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Statistical analysis | Based on the results from a pilot study, the PASS software was used for sample size calculation. With α = 0.05 and β = 0.2, it was determined that 54 cases in each group were needed. Considering a 20% potential loss to follow-up, a total of 195 patients were required for this study.The normal distribution was assessed using a quantile-quantile plot (Q-Q plot) and the Kolmogorov-Smirnov test. Continuous variables were presented as mean ± standard deviation (SD) for normally distributed data or median and interquartile range (IQR) for non-normally distributed data. Numerical differences among the three groups were analyzed using ANOVA for normally distributed variables with homogeneity of variance. Analysis of variance was used for inter-group comparisons at the same time point, and Bonferroni correction was applied for intra-group comparisons at different time points. The chi-square test was used for analyzing categorical data. A p-value less than 0.05 was statistically significant. All statistical analyses were performed using SPSS, Version 25.0 (SPSS Inc., Chicago, IL, USA). | PMC10426143 |
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Results | PMC10426143 |
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General information | Out of the 195 children initially recruited, 14 were excluded due to their inability to cooperate with the measurement of IOP under topical anesthesia before induction. Ultimately, 181 children (59 cases in the NS group, 62 cases in the EL group, and 60 cases in the EH group) were included for analysis (Fig. | PMC10426143 |
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Comparison of IOP | Figure | PMC10426143 |
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Comparison of hemodynamic parameters | HR at TSBP at T | PMC10426143 |
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Discussion | extraocular muscle | AQUEOUS HUMOR | IOP refers to the pressure exerted by the ocular contents on the walls of the eyeball, typically ranging from 11 to 21 mmHg. Various factors influence IOP, including demographic factors such as age and gender and individual physiological factors such as aqueous humor circulation, extraocular muscle tension, and respiratory circulation [Pediatric ophthalmic surgery often requires general anesthesia, and anesthesiologists must ensure the stability of IOP during the induction period to prevent sudden fluctuations. Commonly used drugs for intravenous induction of anesthesia in children include propofol, opioids, and esketamine. In current clinical settings, the combination of propofol and sufentanil is frequently employed, which has been shown to significantly reduce IOP [The pharmacological mechanism of esketamine, similar to ketamine, involves the stimulation of sympathetic nerves by blocking N-methyl-D-aspartate (NMDA) receptors, leading to increased aqueous humor production and extraocular muscle tension, as well as restricted aqueous humor outflow, ultimately resulting in elevated IOP [There are benefits when using esketamine in combination with other anesthetic drugs. Esketamine has a certain sedative and analgesic effect, which can reduce the dosage of other drugs (e.g., opioids, propofol, etc.) in anesthesia induction [Limited studies have investigated the effect of esketamine in combination with other commonly used anesthetics on IOP. Therefore, this study aimed to explore the effect of different doses of esketamine combined with propofol and sufentanil on IOP during the induction of general anesthesia, which appears to be innovative and practical.The study results revealed that the EH group had significantly higher IOP than the other two groups, indicating that esketamine could elevate IOP. However, the IOP of all three groups after induction was lower than at baseline, suggesting that the IOP-reducing effect of propofol and sufentanil was stronger than the IOP-elevating effect of esketamine. Therefore, it is believed that administering esketamine at a dosage not exceeding 0.5 mg/kg, in combination with propofol and sufentanil, does not elevate IOP compared to the pre-induction status. Additionally, the study revealed that the impact of esketamine on IOP was dose-dependent, consistent with the findings of Ausinsch’s study [Using a laryngeal mask airway (LMA) during induction in this study helped reduce the elevation of IOP caused by tracheal intubation in ophthalmic surgery [Prior studies have identified BP as one of the important factors of IOP [This study made several improvements based on previous research. Sobczak et al. [Some limitations present in this study should be acknowledged. Firstly, we did not use bispectral index (BIS) monitoring to assess the depth of anesthesia, as the use of multiple drugs, especially esketamine, may affect BIS readings [ | PMC10426143 |
Acknowledgements | Not applicable. | PMC10426143 |
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Author contributions | Jun Luo and Kuoqi Yin contributed to the conception and design of the study and manuscript drafting. Dinghuan Zhao and Zhao Zhang were involved in data acquisition, analysis, and interpretation. Jun Luo and Kuoqi Yin contributed equally to this work and shared the co-first authorship. All authors have given approval for the publication of the final version of the manuscript. | PMC10426143 |
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Funding | This work has been funded by Tianjin Health Research Project (Approval No. RC20062). | PMC10426143 |
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Availability of data and material | The datasets used and analyzed in the current study are available from the corresponding author on reasonable request. | PMC10426143 |
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Declarations | PMC10426143 |
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Competing interests | The authors declare no competing interests. | PMC10426143 |
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Ethics approval and consent to participate | EYE | This study was approved by the Ethical Committee of Tianjin Eye Hospital and registered at the Chinese Clinical Trial Registry with a registration number ChiCTR2200066586. All the experiment protocol for involving humans was in accordance to the guiding principles of the Helsinki declaration. All parents of the included pediatric patients provided written informed consent. Informed consent was obtained and the consent form was signed by the parents of each participant. | PMC10426143 |
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Consent for publication | Not applicable. | PMC10426143 |
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References | PMC10426143 |
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Subject terms | Anxiety, anxiety | ADVERSE EFFECTS, SECONDARY | We aimed to evaluate the potential anxiolytic effects of premedication with pregabalin, compared with diazepam and placebo. We conducted this non-inferiority, double-blind, randomized controlled trial in ASA classification I-II patients aged 18–70 years, scheduled for elective surgery under general anesthesia. They were allocated to receive pregabalin (75 mg the night before surgery and 150 mg 2 h before surgery), diazepam (5 and 10 mg in the same manner) or placebo. Preoperative anxiety was evaluated using verbal numerical rating scale (VNRS) and Amsterdam Preoperative Anxiety and Information Scale (APAIS) before and after premedication. Sleep quality, sedation level, and adverse effects were assessed as secondary outcomes. A total of 231 patients were screened and 224 completed the trial. The mean change (95%CI) in anxiety scores from before to after medication in pregabalin, diazepam, and placebo groups for VNRS were − 0.87 (− 1.43, − 0.30), − 1.17 (− 1.74, − 0.60), and − 0.99 (− 1.56, − 0.41), and for APAIS were − 0.38 (− 1.04, 0.28), − 0.83 (− 1.49, − 0.16), and − 0.27 (− 0.95, 0.40). The difference in change for pregabalin versus diazepam was 0.30 (− 0.50, 1.11) for VNRS and 0.45 (− 0.49, 1.38) for APAIS, exceeding the limit of inferiority for APAIS of 1.3. Sleep quality was statistically different between pregabalin and placebo groups (Thai Clinical Trials Registry: TCTR20190424001 (24/04/2019) Registry URL: | PMC10272144 |
Introduction | anxiety | ADVERSE EVENTS, SECONDARY | Preoperative anxiety is common and remains an important problem for individuals scheduled for major surgeryPremedication with benzodiazepines has been in used for decades to ease anxiety and promote sleep in patients scheduled for surgeryPregabalin (S-[+]-3-isobutylgaba) is a lipophilic GABA analogPregabalin is also used as a sleep-modulating drugGiven these considerations, the primary aim of this double-blind randomized controlled trial was to compare the anxiolytic effects of premedication with pregabalin, diazepam or placebo in patients scheduled for elective surgery. We hypothesized that patients randomly assigned to receive either pregabalin and diazepam would endorse lower levels of anxiety post-treatment than patients assigned to placebo, but that patients assigned to receive pregabalin and diazepam would not evidence significantly different levels of post-treatment anxiety. The secondary aims were to compare the 3 treatment conditions to each other with respect to sleep quality, overall sedation and rates of adverse events. | PMC10272144 |
Methods | PMC10272144 |
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Ethics | RECRUITMENT | This study was approved by the Ethics Committee of the Faculty of Medicine, Prince of Songkla University, Thailand: REC Number 62-080-8-1 (19/07/2019) and registered with Thai Clinical Trials Registry TCTR20190424001 (24/04/2019). All participants provided written informed consent. Study recruitment began on 29 August, 2019 and continued through 19 December, 2019. The data was anonymized, maintained with confidentiality and in compliance with the Declaration of Helsinki. | PMC10272144 |
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Study design and patient selection | allergy | ALLERGY | This is a randomized, double-blind, placebo-controlled trial. In order to be eligible to participate, potential participants needed to be aged 18 to 70 years old, be scheduled for an elective surgery under general anesthesia, and be rated as having American Society of Anesthesiologists (ASA) physical status I or II.Exclusion criteria included being unable to understand Thai language or provide a written informed consent, having a history of allergy to pregabalin or diazepam, having a history of using pregabalin or diazepam on a regular basis, being pregnant or breast feeding, having renal function impairment (CrCl < 60 mL/min/1.73 m | PMC10272144 |
Measures | PMC10272144 |
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Descriptive measures | pain | Demographic data (sex, age, weight, height, body mass index (BMI), ASA classification and history of previous surgery), baseline clinical variables (vital signs and preoperative pain), and postoperative clinical variables (vital signs) were recorded. | PMC10272144 |
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Primary outcomes | Anxiety, anxiety | We evaluated anxiety before and after receiving 2 doses the study medications prior to surgery using 2 co-primary outcome measures: (1) an 11-point Verbal Numerical Rating Scale (VNRS) with 0 = “Very calm” and 10 = “Very anxious”; and (2) the Amsterdam Preoperative Anxiety and Information Scale (APAIS) Thai version | PMC10272144 |
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Secondary outcomes | Anxiety, anxiety | We assessed preoperative anxiety before receiving the study medications by State Trait Anxiety Inventory (STAI-state) form Y Thai version | PMC10272144 |
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Study population size | This is a non-inferiority trial which hypothesized that the difference in the APAIS scores between participants who received pregabalin and diazepam would be 0. The standard deviation of the APAIS reported in a previous study with a proportional comparison of a visual analog scale of 2.6 was used | PMC10272144 |
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Statistical analysis | anxiety | REGRESSION, SECONDARY | We first computed descriptive statistics to describe the sample and compare the participants assigned to the 3 treatment conditions [using a Fisher’s exact test or Chi-square test as appropriate for the categorical variables, and analysis of variance (ANOVA) F-test or Kruskal–Wallis test as appropriate for the continuous variables] to determine if they were equivalent at baseline. Then, to test the primary hypothesis, we used a mixed-effects random-intercept linear regression with treatment condition as the primary independent variable and the APAIS and VNRS scores as the dependent variable. [Mean values of preoperative anxiety by the APAIS and VNRS (95% confidence interval) before and after receiving study medication in pregabalin, diazepam and placebo groups, the changes in preoperative anxiety by the APAIS and VNRS (95% confidence interval) from baseline and after receiving study medication in each group, and the differences in changes between groups (95% confidence interval) were analyzed using mixed-effects random-intercept linear regression to account appropriately for the repeated measures.] To examine the effects of treatment condition on the secondary outcome variables, we used Kruskal–Wallis and Rank Sum test to analyze sleep quality and Chi-square test for sedation level among the 3 groups. | PMC10272144 |
Discussion | anxiety | The purpose of this study was to determine if patients premedicated with pregabalin would report similar improvements (decreases) in anxiety as those who received the standard treatment, diazepam, for anxiety in this population. The findings indicated that the patients who received the 2 medications evidenced similar improvements in anxiety overtime. However, and unexpectedly, we also found that those who received placebo evidenced deceases in anxiety, and that the anxiety decreases associated with the active treatments were not significantly greater than those that occurred with placebo treatment.Preoperative anxiety is common. The prevalence of clinically meaningful preoperative anxiety has been shown to vary from 12.6 to 59.6%In this study, we utilized 3 tools, the VNRS, APAIS and STAI, to measure preoperative baseline anxiety level before receiving any medications. After the patients had received both the night and on the day of surgery doses of study medications, we employed the VNRS and APAIS to assess the effects of these medications on preoperative anxiety level. All of our patients experienced preoperative anxiety. Our study has shown no significant reduction in preoperative anxiety after receiving pregabalin, diazepam or placebo. This finding is consistent with the results of a systematic review conducted in 2015, which found that the role of pregabalin in reduction of preoperative anxiety measured by visual analog scale in elective surgery remained inconclusiveStudies conducted by Fassoulaki et al.At the same time, many studies have found a positive association between premedication with pregabalin and reducing preoperative anxiety. Gonano et al.The inconstant findings of the efficacy of pregabalin to reduce preoperative anxiety may be related to confounding factors such as different study population, doses and timing of pregabalin administration, as well as methods and timing of anxiety assessment.Regarding comparison of anxiolytic effect between pregabalin and diazepam, one randomized control trial conducted by Jokela et al.Regarding sleep quality, the available data have showed that pregabalin has positive benefits on sleep quality. In rats, pregabalin has been shown to decrease the duration of rapid eye movement sleep (REMS) and significantly increased non rapid eye movement sleep (NREMS)We also found that patients receiving either pregabalin or diazepam had higher sedation scores in comparison to placebo. This finding was consistent with previous studiesThis study aimed to compare the preoperative anxiolytic effect of pregabalin with an active comparator, diazepam as well as placebo. We incorporated 2–3 anxiety assessment tools for confirming patients’ preoperative anxiety level. This study has a number of limitations which should be considered when interpreting the findings. First, our study population consisted of patients scheduled for various kinds of elective surgical procedures as this might pose different influence on preoperative anxiety level. We might have found greater efficacy of one or both of the medications studied had we limited that sample to a single type of surgery or surgical procedure with higher anxiety. Our study participants underwent elective surgery so the results may not be valid to surgical patients with urgent or emergent indications. Also, it is important to note that oral pregabalin is rapidly and completely absorbed with peak level within 1 h and over 90% bioavailabilityDespite these limitations, the study provides information regarding the effects of both pregabalin and diazepam for reducing preoperative anxiety. In a fully powered study that included more subjects than have been included in prior studies, allowing for a direct head-to-head comparison of pregabalin with diazepam, and both of these medications with placebo, and using 2 valid measures of anxiety, we found that in the population studied, while the 2 active treatments were associated with similar beneficial effects, neither evidenced larger effects on preoperative anxiety than placebo. Their findings suggest the possibility that neither treatment may be effective for reducing anxiety for all patients undergoing surgery. More research is therefore needed to help determine the specific populations that might be most responsive to either or both treatments. | PMC10272144 |
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Acknowledgements | The authors would like to thank Ms. Walailuk Jitpiboon for her assistance in the statistical analyses for this paper. | PMC10272144 |
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Author contributions | S.N.: This author helped doing study design, proposal writing, Ethics Committee application, data collection, data analysis, manuscript writing and submission for publication. B.C.: This author helped doing study design, proposal writing, Ethics Committee application, data collection, data analysis and manuscript writing. M.P.J.: This author helped doing manuscript writing and submission for publication. A.F.G.: This author helped doing sample size calculation, data analysis and manuscript writing. J.T.: This author helped doing data collection and manuscript writing. T.C.: This author helped doing data collection and manuscript writing. | PMC10272144 |
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Funding | Supported by Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand. Grant no. 62-080-8-1. | PMC10272144 |
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Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10272144 |
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Competing interests | The authors declare no competing interests. | PMC10272144 |
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References | PMC10272144 |
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Background | PERIODONTITIS | The aim of this work was to evaluate the efficacy of proanthocyanidins (PACNs) as an adjunctive periodontal therapy in patients with periodontitis. | PMC10023589 |
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Methods | MINST, periodontitis, bleeding | PERIODONTITIS, BLEEDING, PLAQUE | Patients with periodontitis (stage III–IV) were included in this randomised clinical study. Patients with periodontitis received 2 different treatment modalities: minimally invasive nonsurgical therapy only (MINST group) or minimally invasive nonsurgical therapy and subgingival application of collagen hydrogels with PACNs (MINST + PACNs group). Clinical periodontal parameters, that is, pocket probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), were evaluated before treatment and after 8 weeks. Concentrations of immunologic markers, matrix metalloproteinase-3 (MMP-3), and tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) in saliva were assessed at baseline and at 8-week follow-up. | PMC10023589 |
Results | MINST, periodontitis | PERIODONTITIS | Forty-six patients diagnosed with periodontitis were randomised into 2 groups: 23 patients in the MINST group and 23 patients in the MINST + PACNs group received the intended treatment. PACNs combined with MINST resulted in additional statistically significant PPD reduction and CAL gain in moderate periodontal pockets by 0.5 mm ( | PMC10023589 |
Conclusions | MINST | Adjunctive use of PACNs in MINST resulted in better clinical outcomes for moderate pockets. Additional use of PACNs improved MMP-3 concentration in saliva more than MINST alone. Biochemical analysis revealed that MMP-3 concentration in saliva reflected the periodontal health state. | PMC10023589 |
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Key words | PMC10023589 |
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Introduction | MINST, tooth loss, Periodontitis | CHRONIC INFECTION, INFLAMMATION, PERIODONTITIS, ALVEOLAR BONE RESORPTION, PERIODONTITIS | Periodontitis is a chronic infection that leads to gingival inflammation, alveolar bone resorption, gingival attachment loss, and tooth loss.Different variations of nonsurgical periodontal therapy, such as minimally invasive nonsurgical therapy (MINST), conventional one-stage or partial quadrant scaling and root planing, and one-stage full mouth oral disinfection, demonstrate successful treatment outcomes.Proanthocyanidins (PACNs) are oligomers or polymers of monomeric flavan-3-ols produced as an end product of the flavonoid biosynthetic pathway.Collagen hydrogels are widely used as active ingredient carriers in pharmacology.To the authors’ knowledge, no clinical study has been done before to evaluate the effects of locally derived PACNs on nonsurgical therapy of periodontitis. The aim of the current clinical study was to assess the effects of collagen hydrogels with PACNs from | PMC10023589 |
Materials and methods | PMC10023589 |
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Trial design | periodontitis | MAY, PERIODONTITIS | We conducted a randomised clinical trial in the Department of Dental and Oral Pathology at the Lithuanian University of Health Sciences in Kaunas, Lithuania, from January to May 2019. Systemically healthy individuals with periodontitis were involved in the study. All included patients must have signed an informed consent form, were willing and able to attend follow-up appointments, and agreed to coded data collection. Patients were given enough time to analyse the protocol of the study and were free to exit the study at any time without a specific reason. After they signed the informed consent form, they were randomly assigned to the control or experimental group (allocation ratio 1:1).The study was performed according to CONSORT guidelines for randomised controlled clinical trials. | PMC10023589 |
Participants | periodontitis, allergic, tooth loss, bone loss | PERIODONTITIS, DISEASES, HIV PERIODONTITIS, BONE LOSS | Male and female patients visiting the Department of Dental and Oral Pathology at the Lithuanian University of Health Sciences in Kaunas, Lithuania, were considered for enrollment.Patients with periodontitis (stage III–IV) were included in the study according to the 2017 World Workshop on the Classification of Periodontal and Peri‐Implant Diseases and Conditions.Patients with stage III and IV periodontitis with slow or moderate rate of progression (A/B) (radiographic bone loss extending to middle or apical third of the root, tooth loss due to periodontitis, maximum probing depth ≥6 mm, horizontal and vertical [≥3 mm] bone loss)Systemically healthy individualsThose with ≥20 remaining teethPatients aged 30 years or olderPatients were excluded if they:Had stage I and II periodontitis (radiographic bone loss in coronal third, no tooth loss due to periodontitis, maximum probing depth ≤5 mm, mostly horizontal bone loss)Had systemic disease(s)Had antibiotic therapy during the last 3 monthsHad periodontal treatment during the last 6 monthsWere pregnant or lactatingClaimed to be allergic to the adjunct (PACNs) | PMC10023589 |
Intervention | MINST | STERILE, CAVITY, HIV PERIODONTITIS | Patients with stage III and IV periodontitis were allocated by the same examiner (RP) to 2 groups: The first group received MINST only (MINST group), and the second group received MINST and single-time subgingival application of collagen hydrogels with PACNs (MINST + PACNs group). Non–commercially available type I collagen hydrogels were manufactured for the research purposes of the current study.Prior to the clinical trial, patients received intraoral cavity preparation (emergency dental treatment, hopeless teeth extraction). Standardisation of the clinical trial was achieved by professional oral hygiene and individual oral hygiene instructions for each patient. During the 8-week term of the trial, the patients were informed not to use other chemical control materials.The clinical trial protocol included several appointments. At baseline, all patients received a periodontal examination, and saliva samples were collected. Samples of unstimulated saliva were collected with 3 sterile cotton rolls deposited for 5 minutes in the oral cavity and stored in sterile tubes at −80 °C. Both treatment groups underwent a full-mouth MINST procedure by a single periodontist (EA). The procedure was performed in a sterile field. Under local anesthesia, the participants underwent MINST with thin and delicate tips together with ultrasonic (Acteon Satelec Suprasson P5 Booster) and hand instruments (Gracey micro-curettes [Hu-Friedy] and mini-curettes [LM-Dental]) and magnification of 4.5×. During the MINST procedure, the periodontist was not informed about the patients’ group assignment (MINST or MINST + PACNs). After the procedure, patients’ group allocation was revealed to the periodontist (EA) by the examiner (RP) and, accordingly, each patient either received adjunctive treatment (the MINST + PACNs group received collagen hydrogel chips with PACNs placed subgingivally in periodontal pockets with PPD ≥4 mm) or had the procedure ended without adjunctive therapy (MINST group). Postoperative care instructions were given.Patients returned for a follow-up appointment 8 weeks after baseline. Periodontal reevaluation of encoded patients was performed by a single examiner (EA). Unstimulated saliva samples were collected in the same manner as mentioned earlier. | PMC10023589 |
Outcomes | For data analysis, pockets were assigned into 2 categories: moderate (PPD, 4–6 mm) and deep (PPD ≥7 mm).Examiner calibration was performed with the use of the Cohen's kappa coefficient (≥0.85). Ten patients with more than 5 teeth with PPD and CAL | PMC10023589 |
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Immunologic investigation | MINST | The relationship of clinical periodontal parameters and MMP-3 and TIMP-1 levels was analysed to assess the efficacy of PACNs in periodontal therapy. Concentrations of immunologic markers, MMP-3, and TIMP-1 in saliva were assessed at baseline and at 8 weeks following therapy.For MMP-3/TIMP-1 detection, unstimulated saliva samples were collected using a Salivette (SARSTEDT AG and Co) saliva sample collection kit. Unstimulated saliva samples were collected at baseline and at 8 weeks following therapy (MINST or MINST + PACNs).Immunologic investigation was performed by the same examiner (RB). Samples were centrifuged at 3500 rpm (2 min) and aliquoted, and a protease inhibitor cocktail (1 mg/mL) was added to each sample. All samples were stored at −80 °C and evaluated using enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's instructions. MMP-3 and TIMP-1 concentration in saliva samples were examined using commercial ELISA kits (Elabscience) and a Multiskan Microplate Photometer (Thermo Fisher Scientific) at a 450-nm wavelength. Results were calculated using the standard curves formed by each assay for saliva and are given in pg/mL. | PMC10023589 |
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Sample size | A sample size of 46 patients, 23 in each group (control and test), was sufficient to detect a clinically important difference in the mean PPD change from baseline in moderate sites at 8 weeks between the control and test groups using a 2-tailed | PMC10023589 |
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Randomisation | MINST, periodontitis, RP | PERIODONTITIS | A total of 46 patients with periodontitis were randomised into 2 groups. RP performed the coding and randomisation of the participants in the treatment groups with a computer-generated randomisation table. At first, the patients were issued unique numbers from 1 to 46. After the coding procedure, a simple randomisation without restrictions was performed, and 2 sets of randomised numbers were generated (23 each). The allocation concealment was done by associating the first set of numbers to the control group (MINST) and the second set to the test group (MINST + PACNs). | PMC10023589 |
Blinding | MINST | STERILE | During the MINST procedure, the clinician (periodontist EA) was not informed about the patients’ group allocation (MINST or MINST + PACNs). After the MINST procedure, the patients’ group assignments were revealed to the clinician by the examiner (RP), and accordingly the patients received the intended treatment.From the beginning of the clinical trial, the patients were not informed which group they have been allocated to. The periodontal treatment was performed under local anesthesia in a sterile field (dental surgery face drapes were used) to eliminate the possibility for patients to monitor the process of the procedure. Thus, patients could not see or feel what type of treatment (MINST of MINST + PACNs) they received. | PMC10023589 |
Statistical methods | CALs, tooth | PLAQUE | The effect of periodontal treatment was reflected by clinical periodontal measures (PPD, CAL, BOP, and PI) and 2 biochemical measures (MMP-3 and TIMP-1 concentrations in saliva). PPD, BOP, CAL, and PI were measured at 6 sites per tooth: mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual. The clinical measurements of third molars were excluded from the study. Per-patient PPD and CAL of moderate pockets at baseline (and at 8 weeks) were obtained by averaging the PPDs and CALs in moderate sites for each patient at baseline (at 8 weeks). Similarly, per-patient PPD and CAL of deep pockets at baseline (and at 8 weeks) were obtained by averaging the PPDs and CALs in deep sites for each patient at baseline (and at 8 weeks). Per-patient PPD (and CAL) change from baseline in moderate (deep) pockets was obtained by averaging the PPD (and CAL) changes within each patient by baseline PPD (4–6 mm or ≥7 mm). Per-patient BOP (and per-patient PI) was obtained by calculating a percentage share of tooth sites with BOP (and plaque) for each patient and by classifying pockets by baseline PPD (4–6 mm or ≥7 mm).Statistical analysis was performed with IBM SPSS 28 statistic software package (IBM Corp.). Shapiro–Wilk test was performed to assess whether clinical periodontal measures (per-patient PPD, CAL, BOP, and PI) and biochemical measures (MMP-3 and TIMP-1 concentrations in saliva) followed a normal distribution. Accordingly, if the data followed a normal distribution, a paired-samples Ethical approval was obtained from the Kaunas Regional Biomedical Research Ethics Committee (No. BE-2-38). All methods were carried out in accordance with relevant guidelines and regulations. All protocols were approved by the Regional Biomedical Research Ethics Committee. | PMC10023589 |
Results | PMC10023589 |
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Participant flow | MINST, periodontitis | PERIODONTITIS, RECRUITMENT | Forty-six patients (stage of periodontitis III–IV) completed the study. Each treatment group (MINST or MINST +PACNs) consisted of 23 randomly selected patients. The number of participants is shown in the CONSORT flow diagram (CONSORT flow diagram of participant recruitment. | PMC10023589 |
Effect on clinical parameters | PMC10023589 |
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Effect on probing depth | MINST, bleeding, SD | BLEEDING, PLAQUE | The mean per-patient PPD dynamics in moderate (baseline PPD 4–6 mm) and deep (baseline PPD ≥7 mm) pockets are presented in Clinical characteristics of sample population at the baseline and after 8 weeks.Significance level is .05 are shown in bold.Paired-samples Related-samples Wilcoxon signed rank test (α=0.05).One-sample BOP, bleeding on probing; CAL, clinical attachment level; MINST, minimally invasive nonsurgical therapy; PACN, proanthocyanidins; PI, plaque index; PPD, pocket probing depth.The mean PPD for moderate pockets in the MINST group significantly differs from the mean PPD for moderate pockets in the MINST + PACNs group at baseline (In both groups, the mean per-patient PPD of moderate and deep pockets reduced statistically significantly after 8 weeks compared to baseline. Specifically, after 8 weeks in the MINST group the mean per-patient PPD reduced from 5.0 (SD = 0.3) mm to 2.1 (SD = 0.6) mm in moderate pockets (The comparison of mean per-patient change in PPD between the 2 treatment types revealed that on average the change in PPD was statistically significantly greater in moderate pockets in the MINST + PACNs group compared to the MINST group (Effect of MINST and MINST + PACNs on change in clinical parameters after 8 weeks from baseline.Significance level is .05 are shown in bold.Independent-samples Independent-samples Mann–Whitney test (α=0.05).BOP, bleeding on probing; CAL, clinical attachment level; MINST, minimally invasive nonsurgical therapy only; PACN, proanthocyanidins; PI, plaque index; PPD, pocket probing depth.Specifically, in moderate pockets the application of adjunctive PACNs resulted in a 0.5-mm greater per-patient PPD reduction ( | PMC10023589 |
Effect on BOP | The BOP dynamics in moderate and deep pockets are presented in | PMC10023589 |
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Effect on salivary biomarkers | MINST, periodontitis | PERIODONTITIS, ADVERSE EFFECTS | A goal of this study was to determine whether MMP-3 might be considered as a biomarker of periodontitis. A total of 46 individuals with periodontitis were included in the study. The effects of MINST and MINST + PACNs treatment on MMP-3 and TIMP-1 levels in saliva are presented in Effect of specific periodontal treatment on MMP-3 (A) and TIMP-1 (B) concentrations in saliva in pg/mL by group and visit. Periodontal treatment groups: MINST and MINST + PACNs. The boxplots of MMP-3 and TIMP-1 concentration in saliva are presented.#MINST, minimally invasive nonsurgical therapy; MMP-3, matrix metalloproteinase-3; PACN, proanthocyanidins; TIMP-1, tissue inhibitor of matrix metalloproteinase-1.The MMP-3 concentration in the MINST + PACNs group reduced statistically significantly after treatment when compared to baseline (The effect of MINST and MINST + PACNs treatment on change in MMP-3 and TIMP-1 concentrations in saliva is presented in The effect of specific periodontal treatment on change in MMP-3 (A) and TIMP-1 (B) concentrations in saliva by group. Periodontal treatment groups: MINST and MINST + PACNs. The boxplots of changes in concentrations of MMP-3 and TIMP-1 in saliva are presented.#MINST, minimally invasive nonsurgical therapy; MMP-3, matrix metalloproteinase-3; PACN, proanthocyanidins; TIMP-1, tissue inhibitor of matrix metalloproteinase-1.No adverse effects were recorded over the whole study period. In addition, we used the economic assumptions and calculated cost-effectiveness of PACNs as a product. Our conclusion is that adjunctive materials (eg, chlorhexidine chips, tetracycline fibers) are similarly cost-effective as PACNs. | PMC10023589 |
Discussion | MINST | PERIODONTITIS, GENERALISED PERIODONTITIS | The current study estimated the effects of PACNs on the treatment of generalised periodontitis by analysing clinical and immunologic parameters. The results showed that adjunctive use of PACNs combined with MINST promoted additional beneficial effects on clinical and immunologic parameters. Adjunctive use of PACNs showed statistically significantly higher PPD reduction in moderate periodontal pockets.To the authors’ knowledge, this clinical study is the first randomised controlled clinical trial to evaluate the efficacy of locally derived PACNs in the treatment of generalised periodontitis. Until now, only 2 clinical studies have reported the investigation of clinical effects of systemically administered PACN nutritional supplements on periodontal health.Clinical research investigating nonsurgical periodontal therapy and adjunctive therapy agreed that locally derived adjuncts showed an additional benefit in clinical parameters.The results of the current study showed no statistically significant differences in BOP values after treatment between the groups. Collagen hydrogels release active substance (PACNs) and dissolve in periodontal pockets quite rapidly (resorption rate usually takes ≥4 weeks).MMPs are one of the most important proteinases, responsible for hydrolysis of components of the extracellular matrix, tissue remodeling, wound healing, and angiogenesis. MMPs can degrade almost all compounds of extracellular matrix and basal membrane, and their redundant activity can lead to periodontal tissue degradation.As mentioned earlier, preclinical studies have shown high antibacterial and anti-inflammatory capacities of PACNs.Our study focused on the analysis of MMP and TIMP proportions to predetermine the level of periodontal tissue destruction in patients with periodontitis. More than 2 decades ago, clinical trials suggested that MMP-3 and TIMP-1 levels may be an additional parameter for periodontal health evaluation.In addition, our study analysed MMP-3 and TIMP-1 changes in relation to nonsurgical periodontal therapy (MINST and MINST + PACNs). Results showed that MMP-3 values in saliva were reduced significantly more in the MINST + PACNs group than in the MINST group. This observation may suggest that additional use of PACNs in periodontal treatment decreases MMP-3 concentrations in saliva more than MINST alone. However, the analysis revealed that no statistically significant differences were observed in the change of TIMP-1 concentration between the groups.There are some limitations of this study. Because the clinical study was designed as a short-term trial (clinical reevaluation 8 weeks after the treatment), it is necessary to determine whether there were any long-term clinical results (at least 6 months after the treatment) | PMC10023589 |
Conclusions | MINST | Within the limits of this study, adjunctive use of PACNs with MINST has been shown to result in additional PPD reduction and CAL gain in moderate periodontal pockets compared to MINST alone. Immunologic investigation showed that additional use of PACNs in MINST reduced MMP-3 concentrations in saliva more than MINST alone. | PMC10023589 |
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Author contributions | All authors collaborated to generate a plan and perform all the necessary experimental procedures. Rasa Pušinskaitė performed the statistical analysis. Rasa Banienė, Evelina Alkimavičienė, and Rasa Pušinskaitė analysed and summarised the experimental results. Evelina Alkimavičienė and Rasa Pušinskaitė wrote the paper. Nijolė Savickienė, Nomeda Basevičienė, Rasa Banienė, and Ingrida Marija Pacauskienė performed the interpretation of data and critically amended the manuscript. All authors approved the final version to be published. | PMC10023589 |
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Conflict of interest | None disclosed. | PMC10023589 |
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REFERENCES | PMC10023589 |
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Funding | This study is a part of project (“Engineering and Functionalization of Delivery System With | PMC10023589 |
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Background | cardiotoxicity | There is rekindled interest in the cardiotoxicity of antimalarial medicines. Halofantrine is associated with QT interval prolongation. Fluconazole and kolanut alter the pharmacokinetics of halofantrine. | PMC10398509 |
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Objectives | The study assessed the electrocardiographic changes of concomitant administration of kolanut or fluconazole with halofantrine and the effects on the QTc interval. | PMC10398509 |
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Methods | Eighteen healthy volunteers received a single oral dose of halofantrine, halofantrine with kolanut or halofantrine with fluconazole in a crossover study. Twelve lead electrocardiography (ECG) was performed to measure the PR and QT interval (QTc). Statistical analysis was with SPSS at 5% level of significance. | PMC10398509 |
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Results | PR intervals were shortened by halofantrine alone and halofantrine with kolanut (169.29 28.67 to 165.29 28.007 and 172.73 29.843 to 163.00 18.336ms) but was prolonged by halofantrine with fluconazole (177.70 27.394 to 186.59 44.434ms). There was prolongation of QTc (384.76 21.727 to 394.12 21.525; 381.36 22.29 to 388.30 17.26 and 382.35 20.08 to 390.84 21.97) in all the three treatment groups at 6 hours, p>0.05. One subject on halofantrine and fluconazole had QTc >440ms. Pre-treatment PR interval (PR | PMC10398509 |
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Conclusion | Concomitant intake of kolanut with halofantrine was significantly decrease cardiac effect of halofantrine. | PMC10398509 |
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Introduction | corona virus disease-19, cardiotoxic, infections, Malaria | PARASITIC INFECTION, MALARIA, INFECTIONS | Malaria is the most important parasitic infection affecting man and may coexist with other infections including HIV. Malaria is a close differential diagnosis of corona virus disease-19 (COVID-19) in this current pandemic. Halofantrine is a synthetic phenanthrene-methanol antimalarial which is chemically related to quinine and mefloquine. Although halofantrine, a potentially cardiotoxic drug is an efficacious antimalarial for the treatment of multi-drug resistant | PMC10398509 |
Objectives | The study assessed the electrocardiographic changes of concomitant administration of kolanut or fluconazole with halofantrine to determine the effects on the QTc and PR intervals. The study also evaluated the influence of serum potassium on the electrocardiographic findings. | PMC10398509 |
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Materials and methods | heart disease | HEART, HEART DISEASE | The study is part of a larger study conducted between September 2003 and January 2004 for which joint University of Ibadan/University College Hospital (UI/IRC/02/0041) ethical approval was obtainedClinical information including family history of heart disease was obtained. Physical examination included blood pressure measurement at baseline and at follow up. Twelve lead electrocardiography (ECG) was performed at 0, 6 and 336 hours with a portable ECG machine P80Six, Esaotebiomedica, Italy, to measure the PR and QT interval (QTc). Electrocardiographic parameters were automatically generated by the machine and confirmed by the authors. Heart rate (Hr.) beats/minutes was measured from the R-R interval by dividing the number of large squares (0.20 s) time unit between consecutive R waves into 300 or the small square (0.04 s) time units into 1500Statistical analysis was with SPSS at 5% level of significance. | PMC10398509 |
Results | HEART | The baseline clinico-electrocardiographic characteristics of healthy volunteers administered halofantrine alone or with either fluconazole or kolanut as shown in Baseline clinico-electrocardiographic characteristics of healthy volunteers administered halofantrine alone or with either fluconazole or kolanutP < 0.05 for halofantrine group versus halofantrine and kolanutThe plasma levels of potassium, sodium, creatinine, and the liver enzymes in the three groups were within the reference intervals at baseline, Baseline biochemical parameters of healthy volunteers administered halofantrine alone or with either fluconazole or kolanutBaseline electrocardiographic intervals significantly correlated with 6-hour values.Heart rates (beats/min) and RR interval (msecs) are shown on Heart rate (/min.) of study participants on halofantrine alone or in combination with kolanut or fluconazoleRR interval (msec) of study participants on halofantrine alone or in combination with kolanut or fluconazoleEight individuals, halofantrine group (2), halofantrine and kolanut group (1), and halofantrine and fluconazole group (5), had pre-treatment PR interval more than 200 msec though they had no clinical symptoms; 5 individuals had PR interval prolonged at 6-hour, same number in the halofantrine and halofantrine kolanut group, but less number, 3 in the halofantrine plus fluconazole group. PR interval, PR interval (msec) of study participants on halofantrine alone or in combination with kolanut or fluconazoleThe QRS duration (msec) and QT interval (msec) are shown on QRS duration (msec) of study participants on halofantrine alone or in combination with kolanut or fluconazoleQT interval (msec) of study participants on halofantrine alone or in combination with kolanut or fluconazoleQTc was derived from Bazzett's formula QT/√RR. There was prolongation of QTc (384.76 21.727 to 394.12 21.525; 381.36 22.29 to 388.30 17.26 and 382.35 20.08 to 390.84 21.97 msec) in all the three treatment groups at 6 hours but were not statistically significant, QTc interval (msec) of study participants on halofantrine alone or in combination with kolanut or fluconazoleThough no patient had QTc prolongation greater than 440 msec pre-treatment, it occurred in one patient on halofantrine and fluconazole at 6 hours, and in another on Day 14. Pre-treatment PR interval (PR | PMC10398509 |
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Discussions | In this study, baseline electrocardiographic intervals significantly correlated with 6-hour values. QT and QTc at 6 hrs and 336 hrs (Day 14) correlated well with pre-treatment value. Electrocardiographic monitoring at 6 hours may be a most important single point measurement of assessment of the electrocardiographic changes in the heart following use of halofantrine. Halofantrine, a phenantherene methanol has a half-life of 4 days and is metabolized to an active metabolite, N-desbutylhalofantrine by cytochrome P 450 (CYP3A4). Subjects, who were healthy volunteers, were not on any of the drugs known to be associated with prolonged QT interval and the serum potassium levels were within normal limits.Concomitant intake of kolanut with halofantrine was found to significantly decrease Cmax and AUC of both halofantrine and the metabolite desbutylhalofantrine | PMC10398509 |
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Conclusion | In conclusion we found halofantrine alone or in concomitant use with fluconazole caused prolonged QT interval which correlated with the baseline, whereas use of kolanut with halofantrine caused reduced PR interval. Further studies are however needed to determine if such QT prolongation is accentuated by presence of background hitherto undiagnosed abnormality or an accentuation of such abnormality. | PMC10398509 |
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Acknowledgement | Abstract of this study was accepted for presentation at the IX | PMC10398509 |
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Conflict of interest | Nil | PMC10398509 |
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Introduction | depression, coronavirus disease 2019, anxiety | CORONAVIRUS DISEASE 2019, POLAND | With the spread of the coronavirus disease 2019 (COVID-19) pandemic, people have been recommended to wear masks in various settings around the world [A recent study revealed notable disparities between Poland and China in mask-wearing and associated health outcomes. Specifically, far fewer Poles (35.0%) wore masks compared to the Chinese (96.8%), and they reported higher levels of anxiety, depression, and physical symptoms by COVID-19 [Although masks have been shown to be effective in reducing the spread of COVID-19 [The use of the aroma essential oils has potential to alleviate the stress caused by wearing masks. Aroma essential oils, a well-known non-invasive, natural compound [Therefore, in this study, a double-blind, randomized controlled trial was conducted to determine the stress-alleviating effects and safety of using aroma seals while wearing masks. Citrus is the one of the most popular scents in the world [ | PMC10653515 |
Methods | PMC10653515 |
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Study design | In this study, a double-blind, randomized controlled trial was conducted to assess the effects of aroma seals on adult participants. The study was conducted between November 11, 2021, and December 20, 2021. The participants were informed in advance about the study’s objectives and methods, and written informed consent was obtained. This study was approved by the Research Ethics Committee of Hoshi University (approval no. 2021–15). The study protocol was pre-registered at the University Hospital Medical Information Network Center prior to the initiation of the study (UMIN trial ID: UMIN000045941, first registered 01/11/2021). This report is from “The effectiveness of using an aroma seal for stress relief when wearing a mask: a parallel group comparison test” of the study. All study methods were performed in accordance with the relevant guidelines and regulations. | PMC10653515 |
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Participants | mental illness, epilepsy, chronic diseases, allergies, hypertension, allergic reactions | ALLERGIC REACTION, EPILEPSY, CHRONIC DISEASES, ALLERGIES, HYPERTENSION | In this study, we recruited 67 healthy university students aged 18 years or older who understood the study’s purpose and content, provided written consent, and volunteered to participate. Eligible participants were those who, to the extent that it did not impede the conduct of the study, had the ability to comprehend the Japanese language, both spoken and written, allowing them to understand the study instructions. We excluded individuals who: (1) declined to participate voluntarily; (2) regularly used aroma essential oils; (3) disliked the scent of aroma essential oils; (4) had known allergies to aroma essential oils; (5) had chronic diseases (such as hypertension or epilepsy); (6) required drug therapy for mental illness; (7) experienced allergic reactions during the patch test; (8) did not report stress from wearing masks initially; or (9) were deemed ineligible by the principal investigator. After applying these exclusion criteria, a total of 62 participants were included in the study. | PMC10653515 |
Randomization and masking | Participants were randomly assigned to one of the two groups (intervention or control) in a 1:1 ratio, and were double-blinded to ensure that the participants and data analysts in the study could not discriminate between the groups of participants. The permuted block method with block sizes of 2 and 4 was used for randomization assignment. An independent allocation coordinator prepared the aroma and placebo seals, creating an allocation table for each participant, including unique identification codes. Random allocation was conducted by a third party not involved in the study, and allocation results were securely stored in a locked safe. Blinding of intervention providers and data analysts was maintained until the completion of data analysis. Randomization was performed using the R statistical software(version 4.0.2, Foundation for Statistical Computing, Vienna, Austria). | PMC10653515 |
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Procedures | skin allergy, aromas, allergic reactions | SKIN ALLERGY, RECRUITMENT, ALLERGIC REACTION | The baseline period in our study refers to the two-week period immediately preceding the intervention period, during which participants applied the seals to their masks. The baseline values used in our analysis were obtained from the questionnaire responses collected on the day before the intervention started.All enrolled participants had their health status checked, followed by a skin allergy test (patch test) with aroma oil; only those who did not have allergic reactions were included in the study. The participants were randomly divided into two groups. After a one-week screening period, participants in both groups used seals when they felt stressed while wearing masks during the two-week intervention period. The seal was applied once a day while going out.In this study, all participants were initially administered a questionnaire survey to confirm their preferred aromas, choosing from aroma categories such as Citrus, Floral, Trees, Oriental, Herb, Spices, and Resin. This assessment, which allowed participants to select multiple preferred aromas, was conducted to confirm comparability by ensuring that there were no differences in aroma preferences between the two groups after randomization. Orange–lime essential oil was adopted for the aroma used in the seal due to its relaxing and refreshing effect. To ensure participants’ comfort, participants themselves were allowed to make adjustments, such as cutting the seal with scissors to make it smaller or placing it further from the nose if they found the fragrance too strong.The responses to the questionnaires were tabulated at three time points: before the implementation of the study, during the intervention period, and at the end of the study. Specifically, the Google Form link for the survey was sent to all participants at noon on the day of tabulation, with responses required by the end of the day. Utilizing Google Forms for the survey ensured that there was no direct contact between the researchers and the participants throughout the study. The recruitment process was completed within a week, by November 10, 2021, and the follow-up was finalized by November 20, 2021. The intervention began within the first week after all participants were randomized. The initial two weeks served as the baseline period, followed by the two-week intervention period. | PMC10653515 |
Study outcomes | Anxiety, anxiety, breathlessness, depression, Depression | The primary outcome was the Depression, Anxiety, and Stress Scale-21 (DASS-21) [The DASS-21 is a 21-question rating scale comprising a three-factor construct of depression, anxiety, and stress. The responses to the questions were scored as 0 (did not apply to me at all), 1 (applied to me to some degree or some of the time), 2 (applied to me to a considerable degree or a good part of time), and 3 (applied to me very much or most of the time). The participants responded by selecting the option that was closest to their current condition in the last week. The responses to each question (from 0 to 3 points) were tabulated, and the scores for depression, anxiety, and stress for each factor item were calculated and evaluated. In this study, we used the Japanese version of the DASS-21 (Short-form version of the Depression Anxiety Stress Scale) to assess participants’ levels of depression, anxiety, and stress [To assess whether they were feeling breathlessness while wearing a mask, participants responded by choosing the option that was closest to their condition in the last two weeks. The questions were scored from 1 to 4 points, and the response options ranged from 1 (not feeling breathlessness) to 4 (feeling breathlessness). In this study, we employed a 4-level rating to evaluate the perception of mask breathless among participants. This approach was considered suitable for our study’s specific context and objectives.The WHO-5 Well-Being Index consists of five questions, with each question scored from 0 to 5 points. The response options ranged from 0 (at no time) to 5 (all of the time). Participants responded by selecting the option that was closest to their condition in the last two weeks. The original items for the five questions were as follows: Question 1 (W1): “I have felt cheerful and in good spirits”; Question 2 (W2): “I have felt calm and relaxed”; Question 3 (W3): “I have felt active and vigorous”; Question 4 (W4): “I woke up feeling fresh and rested”; and Question 5 (W5): “My daily life has been filled with things that interest me.” In this study, we used the Japanese translated version of the WHO-5 [ | PMC10653515 |
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Statistical analysis | depression | ADVERSE EVENTS | Descriptive statistics were used to present the demographic characteristics of the participants. Numerical data (age, number of outings per week, and outcome measures) were presented as means and standard deviations, whereas categorical data (sex, stress, and favorite aroma) were presented as frequencies and ratio. To determine the improvement in the primary outcome of the scale for stress, changes in DASS-21 scores measured at the time points (weeks 1 and 2) from those measured at the baseline were assessed for each group (aroma- and placebo-seal use group). To determine whether breath comfort while wearing a mask improved, the groups were assessed for improvement in the mask-breathlessness score on week 2. In addition, to assess improvements in mental health by reducing stress caused by wearing a mask, the changes in WHO-5 scores for each group at the time of measurement (week 2) with respect to baseline values were evaluated. To evaluate safety, the number of participants who experienced adverse events and the incidence of these adverse events were recorded for each group. All outcomes were coded using the statistical software SAS (Version 9.4, SAS Institute, Inc., Cary, NC, USA). DASS-21 and mask-breathlessness scores were analyzed using a mixed model for repeated measures (MMRM) with each outcome variable baseline values as covariates. WHO-5 scores were analyzed using a mixed-effects model analysis of covariance, also incorporating each outcome variable baseline values. A p-value < 0.05 for all tests was considered statistically significant. All analyses were conducted using a two-tailed test. To ensure complete data, a Google response form was configured to prevent submissions of incomplete forms, resulting in zero missing values. Except for those who withdrew from the study, all participants completed all outcomes at each time point; therefore, the number of participants for efficacy and safety analyses was the same. Additionally, we calculated Cohen’s d effect sizes for stress, depression, and other relevant measures to assess the practical significance of the results. Efficacy assessments were performed on participants who successfully completed all trial sessions, while safety assessments were conducted for those who received at least one intervention. | PMC10653515 |
Results | PMC10653515 |
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Participants’ information | In this study, 67 participants were screened, and 62 were included and randomly assigned to one of two groups: an aroma-seal use group ( | PMC10653515 |
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Flow chart of participant allocation. | The participants’ demographics and baseline characteristics were comparable between the groups ( | PMC10653515 |
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Demographic and baseline characteristics of study participants in the aroma- and placebo-seal use groups. | The values in | PMC10653515 |
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Assessment of depression, anxiety, and stress using the DASS-21 | depression, anxiety | DASS-21, which assesses depression, anxiety, and stress, was utilized in our study. In its evaluations at baseline, 1 week, and 2 week, the scores for the Aroma-Seal Use Group appeared to show a decreasing trend ( | PMC10653515 |
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Comparison of DASS-21 score changes from baseline in the aroma- and placebo-seal use groups. | LSMD, least squares mean difference | PMC10653515 |
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Improvement in discomfort associated with wearing masks | breathlessness | The aroma-seal use group had mean breathlessness scores of 2.48 ± 1.09, 1.74 ± 0.89, and 1.84 ± 0.86 at baseline, first week, and second week of the intervention, respectively, indicating that the scores changed from “it’s rather breathlessness” to “it’s not very breathlessness” in many patients. Conversely, the placebo-seal use group had mean breathlessness scores of 2.37 ± 0.93, 2.17 ± 0.79, and 2.30 ± 0.92 at baseline, week 1, and week 2, respectively, with no significant change in breath comfort when wearing a mask. Furthermore, the aroma-seal use group showed a significantly lower 0.5-point difference in mean breathlessness score change from baseline than the placebo-seal use group in the one- and two-week time points ( | PMC10653515 |
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Comparison of mask-breathlessness score change from baseline in the aroma- and placebo-seal use groups. | LSMD, least squares mean difference | PMC10653515 |
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Assessment of mental well-being using the WHO-5 rating scale | The average score for each item of the WHO-5 was observed to be higher in the intervention group compared to the placebo group ( | PMC10653515 |
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Comparison of WHO-5 score changes from baseline at the end of the two-week intervention in the aroma- and placebo-seal groups. | LSMD, least squares mean difference | PMC10653515 |
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Adverse event reporting | ADVERSE EVENT | Safety was assessed for the 61 participants. The number of days of seal use during the intervention period was 5.6 ± 1.2 and 5.4 ± 1.3 days per week in the aroma- and placebo-seal use groups, respectively, and all 61 participants completed the two weeks of the intervention period. One adverse event (3.2%) each was reported in the aroma- and placebo-seal use groups ( | PMC10653515 |
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A summary of adverse events in the aroma- and placebo-seal use groups. | ADVERSE EVENT | Adverse events were defined as those occurring between the time the seal was applied and 14 days after the last use of the mask seal. | PMC10653515 |
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Discussion | depression, breathlessness | INFLUENZA | This study investigated whether mask seals containing orange–lime essential oils could alleviate stress and breathlessness while wearing a mask and improve mental well-being. The findings revealed a significant improvement in stress and depression, as determined by the DASS-21 scores, in the aroma-seal use group compared to the placebo-seal use group, as well as significantly moderated breathlessness with mask use. In addition, the aroma-seal use group scored significantly higher than the placebo-seal use group on the WHO-5 question, “I have felt calm and relaxed.”Based on the findings of this study, aroma seal masks may have utility in various aspects of daily life. For example, they could offer numerous advantages during extended stays on airplanes. Firstly, the aroma’s scent has been suggested to reduce stress and induce relaxation, potentially aiding in relaxation and stress reduction during long flights. Additionally, aroma seal masks may enhance comfort and improve sleep quality, making them a potential contributor to passenger comfort and well-being in situations such as air travel. With these possibilities in mind, there is potential to enhance the quality of life for many individuals.Previous studies have shown that essential oils are effective and safe as fragrances and that inhaling them has psychophysiological effects on humans [While wearing masks, breathlessness was shown to be relieved more effectively in the aroma-seal use group than the placebo-seal use group. In recent years, aroma sprays for masks have become available on the market; however, aroma seals are less likely to volatilize than aroma sprays and their effects are expected to last longer. Because masks are often worn for long periods of time, aroma seals may be more effective in alleviating breathlessness than sprays.Among the WHO-5 questionnaire items on the Mental Status Assessment Scale, the score on the item ’I have felt calm and relaxed’ was statistically significant, consistent with the previous reports [Several studies on the safety of essential oils have recently been conducted [This study has some limitations. First, there was a gender bias among the participants because nearly 90% of the study participants were female. Women are generally known to have a better sense of smell than men [The significance of this research is that it was conducted in a situation in which people all over the world were wearing masks due to the spread of COVID-19 and experiencing stress and breathlessness. In this study, we conducted a randomized controlled trial using citrus aroma seals to alleviate stress and breathlessness caused by wearing masks. So far, there have been no reports of such a study being conducted on healthy subjects in their daily lives. Masks have traditionally been used to prevent conditions like influenza [Ambient scents have long been recognized to influence people’s moods and social, emotional, and cognitive well-being [ | PMC10653515 |
Conclusion | This study demonstrated the efficacy of aroma seals containing orange–lime essential oils in relieving mental stress and improving the comfort of breathing while wearing a mask. Therefore, using aroma seals while wearing masks can be expected to improve mental health and alleviate discomfort in breathing, improving the quality of daily life of healthy people worldwide. | PMC10653515 |
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Supporting information | PMC10653515 |
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DASS-21 scores in the aroma-seal use group and placebo-seal use group at baseline, 1 week, and 2 week. | (DOCX)Click here for additional data file. | PMC10653515 |
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WHO-5 scores in aroma seal and placebo groups at baseline and 2 week. | (DOCX)Click here for additional data file. | PMC10653515 |
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CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.(DOC)Click here for additional data file.(DOC)Click here for additional data file.(XLS)Click here for additional data file.(XLS)Click here for additional data file.(XLS)Click here for additional data file.The authors would like to thank all the students who participated in this study. We would like to thank Enago ( | PMC10653515 |
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