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Introduction | reduced psychological distress, depression, meaningfulness, ’ | DISORDERS | Health-promoting lifestyle is a multidimensional model of perceptions and activities that begin with personal motivation and help to improve and promote health and self-care [The culture that dominates the society is one of the factors that can affect people's behavior and lifestyle [Lifestyle and HPL usually develop during adolescence [Adolescents are at risk for many different high-risk behaviors and health problems such as immobility, unhealthy eating, tobacco smoking, unprotected sexual relationships, mental disorders, violence, and suicide which can seriously threaten their adulthood health [Meaning-based approaches and logotherapy are among the strategies with potentially positive effects on adolescents’ problems [Different studies have so far been conducted into the effects of logotherapy on the different aspects of health. For example, a study showed that participation in logotherapy-related programs had a negative relationship with suicidal thoughts and depression symptoms and positive relationship with self-esteem and perceived social support [Logotherapy needs therapist-client interaction [Different studies used logotherapy to improve the different aspects of health. For instance, a study showed that a meaning-based intervention by nurses during the COVID-19 pandemic significantly reduced stress and depression and improved meaningfulness among college students, which could lead to reduced psychological distress and improved mental health [Despite the wealth of studies into the effects of logotherapy on the different aspects of health and life, there are limited data about the effects of virtual logotherapy (VL) on HPL, particularly during epidemics such as the current COVID-19 pandemic. Therefore, the present study was conducted to narrow this gap. The study aimed to investigate the effects of VL on HPL among single-parent adolescent girls during the COVID-19 pandemic. | PMC10198750 |
Methods | PMC10198750 |
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Design | This single-blind randomized clinical trial was conducted in Iran. | PMC10198750 |
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Participants and setting | DISEASES, DISORDERS | Study setting was the support organization for vulnerable individuals in Tehran, Iran, and study population consisted of all single-parent adolescent girls who referred to the study setting. Participants were 88 girls who were willing to participate in the study and met the following eligibility criteria: age 13–18 years, having just one parent, and no self-report history of psychological disorders or specific diseases. More than two absences from the intervention sessions were the exclusion criterion. It should be noted that ethical approval was given by the organizational ethics committee of the nursing-midwifery and rehabilitation faculty and participants entered the study voluntarily and completed the informed consent form. Participants were randomly allocated to a control and an intervention group through block randomization and using an online randomization module (Sample size was calculated using the results of a study into the effects of education for student health ambassadors on HPL among adolescent girls. Accordingly, with a confidence level of 0.85, a power of 0.80, a standard deviation of 15 for the HPL score, and at least 10 score increase in the mean score of HPL after VL to be considered significant [Sample size calculation formula | PMC10198750 |
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Instruments | disability or problems such as parent loss | Data were collected using a demographic questionnaire and the Adolescent Health Promotion Short-Form. The demographic questionnaire had ten items on age, educational year, weight, height, family size, birth rank, parent (father or mother), adequacy of monthly family income, and parent’s educational level and occupation.The Adolescent Health Promotion Short-Form was used for HPL assessment. This scale has 21 items in the following six main dimensions: nutrition (Participants in the intervention group received VL in three–five person small groups in eight 90-min biweekly online and offline sessions. The participants resided in their respective houses and used their mobile phones and the intervention was carried out using the live broadcasting of educational software of the Ministry of Education and voice calls in WhatsApp messenger, as well as the possibility of sending files in this software.Educational materials were provided through lectures and group discussions. Moreover, real stories of famous people with enormous success despite disability or problems such as parent loss were narrated to participants and discussed. The important points of each session were also provided to participants through pamphlets and pictures for the purpose of offline use. The audio file of each session was also provided to them at the end of the session. The VL program (Table The content of the logotherapy sessions | PMC10198750 |
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Data analysis | Data were analyzed using the SPSS software (v. 26.0). Pretest and posttest data were described using the measures of descriptive statistics (namely mean, median, standard deviation, and interquartile range) and analyzed using the independent-sample | PMC10198750 |
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Discussion | anxiety, HPL behaviors, frustration, nutritional behaviors, depression, Logotherapy | SAID | The aim of this study was to investigate the effects of VL on HPL among single-parent adolescent girls during the COVID-19 pandemic. Findings showed that VL significantly improved HPL among these girls. This is in agreement with the findings of previous studies [The findings of the present study revealed that VL had significant positive effects on the nutritional behaviors of single-parent adolescent girls. Healthy nutrition is a key component of adolescent health [We also found that VL significantly improved participants’ mean score of physical activity. This dimension refers to a healthy and regular physical activity pattern in lifestyle [Study findings also revealed significant increase in the mean score of the health responsibility dimension of HPL after VL. This is in line with the findings of a study in China which showed that meaning-based psychological intervention significantly improved health and life responsibility in Chinese college students [We also found that VL significantly improved participants’ stress management ability. Single-parent adolescents are vulnerable to stress. Different studies in Iran have shown that logotherapy helps individuals find meaning and purpose in life and thereby, improves their general health and quality of life and reduces their anxiety and depression [Our findings also indicated that VL had significant positive effects on the social support dimension of HPL. The social support can positively affect engagement in HPL behaviors [VL in the present study also significantly improved life appreciation among single-parent adolescent girls. Life appreciation refers to purposefulness in life [The logotherapy intervention in the present study was virtually implemented due to COVID-19-related restrictions such as physical distancing. Most healthcare providers resorted to virtual education during the COVID-19 pandemic [Some eligible girls could not participate in the study due to their limited access to smart phone. Virtual methods have some limitations such as clients’ preference to receive face-to-face services, limited access of some clients to information technology, inappropriateness of these methods for some types of counseling, lack of official guidelines, heavier workload, limited financial and organizational support, lack of the necessary infrastructures, and limited supervision [Generally, in explaining the above results, it can be said that changing behavior, lifestyle improvement and health promotion require motivation and responsibility in people. Logotherapy is also an approach that tries to reduce frustration and create motivation in people to increase their responsibility towards their health and lifestyle. It seems that the results of this research are also due to the increase in motivation, hope, and responsibility of people under the influence of logotherapy. | PMC10198750 |
Limitations | Although participants were randomly allocated to the study groups, there were between-groups differences respecting some of the demographic characteristics of participants. Moreover, the non-normal distribution of some study variables necessitated the use of non-parametric methods for data analysis.In addition, the inability to send a file (such as a video) with a size higher than 100 MB was one of the challenges of using WhatsApp. Also, due to the virtual nature of the intervention and the unwillingness of the participants to make a video call, it was not possible for the researcher to observe the participants and it was only possible to receive verbal and textual feedback. But the ability to send text messages on WhatsApp can be considered as an advantage. Because some participants could express their opinions more easily. | PMC10198750 |
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Conclusion | DISEASES | VL is effective in significantly improving all aspects of HPL, namely nutrition, physical activity, life appreciation, social support, health responsibility, and stress management among single-parent adolescent girls. Therefore, healthcare authorities are recommended to use VL to promote health and prevent illnesses among vulnerable adolescents. Future studies are recommended to compare the effects of face-to-face and virtual logotherapy in different vulnerable populations such as individuals with specific diseases, addicts, and homeless individuals, as well as healthy individuals. | PMC10198750 |
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Acknowledgements | This study was a master’s thesis approved by the Tehran University of Medical Sciences, Tehran, Iran. We would like to thank the Research Administration of this university and the authorities of comprehensive healthcare centers in the south of Tehran, Iran. | PMC10198750 |
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Authors’ contributions | FH, AS and ShP: design of study and acquisition of data; FH, ShP and RN: drafting the manuscript. RN: data analysis; All authors assisted in revising the text and approved the final manuscript. | PMC10198750 |
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Funding | This study was funded and supported by Tehran University of Medical Sciences (TUMS). | PMC10198750 |
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Availability of data and materials | The datasets generated and/or analysed during the current study are not publicly available due [We do not have consent from all patients to publish this data] but are available from the corresponding author on reasonable request. | PMC10198750 |
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Declarations | PMC10198750 |
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Ethics approval and consent to participate | Ethical considerationsThis research was performed in accordance with the Declaration of Helsinki. This study has the approval of the ethics committee of Tehran University of Medical Sciences (code: IR.TUMS.FNM.REC.1398.181), and was registered in the Thailand Clinical Trials Registry (code: TCTR20200517001). We provided participants with information about the aim and methods of the study, confidentiality of their data, voluntariness of participation in and withdrawal from the study, and users of the study findings. After being informed of the benefits and risks of research, Informed consent was obtained from all subjects or their legal guardian(s).At the end of the study, educational materials were provided to participants in the control group in a single session and also through a stress management for adolescents’ pamphlet. | PMC10198750 |
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Consent for publication | Not applicable. | PMC10198750 |
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Competing interests | The authors declare no competing interests. | PMC10198750 |
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References | PMC10198750 |
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Objective | To determine whether the blood lipidomic response to supplementation with two rTG supplements, varying by degree of re-esterification, would differ between treatments. | PMC9882700 |
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Design | ® | This was a double-blind, parallel-design, single-center, 128-day study with sixty young, healthy subjects randomized into two groups. One group received a >95% rTG (Ultimate Omega®), as 1,000 mg capsules containing 325 mg eicosapentaenoic acid (EPA) and 225 mg docosahexaenoic acid (DHA), and the other received a <70% rTG (MEG-3) as 1,000 mg capsules containing 300 mg EPA and 200 mg DHA. Total intake was 2,750 and 2,500 mg EPA+DHA for the Ultimate Omega® and MEG-3 groups, respectively, with blood drawn at 4, 16 and 24 weeks and analyzed for serum and erythrocyte phospholipid fatty acid (PLFA) content. | PMC9882700 |
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Results | For erythrocyte PLFA profiles, EPA, docosapentaenoic acid (DPA) and DHA percentage of total erythrocyte PLFA were significantly greater for the Ultimate Omega® group than for the MEG-3 group, at week 16 ( | PMC9882700 |
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Conclusions | These data suggest that the percentage of rTG in rTG fish oil preparations may evolve as a new chemoprofile/quality control marker that can influence its lipidomic pharmacodynamics. Additional investigations to assess the physiologic/vascular and metabolic/inflammasome responses to concentrated fish oil preparations differing in the percentage of rTG are warranted. | PMC9882700 |
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Data Availability | All relevant data are within the paper and its | PMC9882700 |
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Introduction | hypertriglyceridemia, TG | HYPERTRIGLYCERIDEMIA | The use of supplements with high concentrations of omega-3 polyunsaturated fatty acids (N3PUFA) has become increasingly popular, delivering greater than 90% N3PUFA, most commonly as free fatty acids (FFA), ethyl esters (EE), or re-esterified triglycerides (rTG). The re-esterification process involves the transfer of N3PUFA from fish body oil (FBO) TG-bound fatty acid (FA) concentrates to ethanol, yielding EE concentrates which are then subjected to molecular distillation. The resulting distillate is enzymatically re-esterified into a TG form similar to natural FBO. The fidelity of re-esterification into a TG form is variable and may be a misnomer, as the glyceride profile of rTG supplements is approximately 55–60% TG, 38–42% diglycerides, and 1–3% monoglycerides [Several intervention comparator studies of ≥ 12 weeks have indicated a relationship between lipid format and blood lipidomic response. Neubronner et al. randomized 150 statin therapy subjects with moderate hypertriglyceridemia into three groups: fish oil concentrate given as rTGs or EEs, delivering equal amounts of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), or a corn oil placebo [Given the potential for incomplete re-esterification of acylglycerides into rTG forms of N3PUFA [ | PMC9882700 |
Subjects and methods | PMC9882700 |
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Study design | RECRUITMENT | This study was a randomized, double-blind, parallel-design, single-center study conducted in accordance with local regulations, the International Conference on Harmonization E6 Guideline for Good Clinical Practice (GCP), and the Declaration of Helsinki. The study was sponsored by Nordic Naturals (Watsonville, CA) and conducted at Nutrasource Diagnostics (Guelph, Ontario). Ethical approval was obtained from an Institutional Review Board contracted by Nutrasource. The study was registered at ClinicalTrials.gov (Identifier #NCT02628483). Subjects were recruited in response to advertisements or from study site databases. Written, informed consent was obtained from all participants before any study-related activities. Recruitment began in March of 2016; the first subject was enrolled on March 15, 2016 and the last subject completed the study on December 8, 2016. The total intervention duration was 128 days, with two parallel groups: one group received a >96% TG form of N3PUFA (Ultimate Omega®; Nordic Naturals [UO]) and the other group received a <70% TG form of N3PUFA (MEG-3®, DSM Nutritionals, Heerlen, Netherlands [M3]). | PMC9882700 |
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Fish oil products | UO bulk oil was manufactured and provided by Nordic Naturals; M3 bulk oil was manufactured by and purchased directly from DSM (Dartmouth, Nova Scotia, Canada) by a soft-gel dosage form manufacturer (Select Supplements, Carlsbad, California, USA). Percent TGs (%TGs) in the bulk oils were initially evaluated by each supplier. The soft-gel manufacturer measured %TGs in UO using The American Oil Chemists’ Society (AOCS) official method Ce 5b-89 [ | PMC9882700 |
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Subjects | The study enrolled healthy, non-smoking, normolipidemic adults, aged 18–35 years, with a body mass index (BMI) of 18.5 through 24.9 kg per mThe following were the main exclusion criteria for this study: BMI ≥ 25 kg/m | PMC9882700 |
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Randomization and blinding | The subjects were randomly assigned 1:1 to either the UO or M3 group. The principal investigator, co-investigators, study personnel, and study participants were blinded to the treatment through the completion of the study. Blinding was maintained by labeling both products in a similar manner, differentiated only by their computer-generated randomization code, and with no other distinguishing information between the two products. In addition, the M3 capsules were similar in size and shape to the UO capsules. Allocation concealment was implemented by means of a restricted access drug dispensary unit within the CRO. An allocation schedule facilitated the release of subject supplements to trial personnel as scheduled. | PMC9882700 |
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Study interventions | UO was provided as 1,000 mg soft-gel capsules (Batch 141179), each containing 325 mg EPA and 225 mg DHA, along with 90 mg of other FA, in a 90% re-esterified TG form. M3 was provided as 1,000 mg soft-gel capsules (Batch153143), each containing 300 mg EPA and 200 mg DHA, along with 90 mg of other FA in a 70% re-esterified TG form. Subjects in the respective groups were instructed to consume five capsules daily, taken orally with water at breakfast, providing a total daily amount of 2,750 mg EPA+DHA for UO and 2,500 mg EPA+DHA for M3.The daily dosage level was selected in order to provide an easily comparable, statistically significant increase in ERC phospholipid (PL) N3PUFA content and serum PL N3PUFA content, using two similar chemical forms of EPA and DHA differing only in degree of re-esterification. The M3 oil was chosen because it approximated the EPA (92% w/w) and DHA (89% w/w) profile in UO. No dietary or lifestyle advice/counseling was given to study participants. Treatment compliance was evaluated at clinic visits by counting any unused capsules; minimum acceptable compliance was judged to be at least 80% of the intended dose. Study materials were provided in externally sealed, standard, high-density polyethylene bottles, each of which contained 150 capsules. | PMC9882700 |
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Outcome measurements | TG, Diteba | ADVERSE EVENTS, SECONDARY | The primary outcome measures were the intergroup comparisons of the ERC phospholipid fatty acid (PLFA) profiles at week 16 and the serum PLFA profiles at week 4. The secondary outcome measures were the comparisons of the ERC PLFA profiles at weeks 12 and 24, and blood lipids (i.e. TG, total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], and high-density lipoprotein cholesterol [HDL-C]) at week 24. Safety parameters, including vital signs, blood chemistry (Chem 20), biometrics and adverse events (AE), were also assessed at each visit. Intensity of AE was graded on a 3-point scale (mild, moderate, severe) and reported in detail in the study records. The Medical Dictionary for Regulatory Activities (MedDRA version 19.1) terminology was used to classify all AE with respect to System Organ Class and preferred term.Serum samples and ERC samples were analyzed for PLFA profiles by GC-FID (Gas Chromatography-Flame Ionization Detector) using in-house developed and validated methods (Diteba Laboratories, Inc., Mississauga, Ontario, Canada). Venous blood samples were collected in serum separator tubes (SST) and EDTA (K2) tubes. Samples were processed according to standard clinical procedures for these collection tubes, and serum was collected from the SST tubes. ERC were collected from the EDTA tubes as a red cell pack after removal of the plasma and white blood cells. Samples were stored at -80°C prior to analysis. At time of analysis, frozen samples were thawed in an ice water bath. Serum samples were extracted with chloroform/methanol 2:1. Prior to injection, PLs were separated with a Hybrid SPE-PL cartridge (MilliporeSigma, St. Louis, MO). ERC samples were processed with BCl | PMC9882700 |
Sample size estimation | Based on many previous omega-3 studies by the CRO, it was estimated that twenty-four (24) subjects per group would be required for acceptable statistical analysis. With an expected attrition rate of twenty-five (25) %, 30 subjects per group were required for enrollment. However, a formal sample size or power calculation was not performed. | PMC9882700 |
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Statistical analyses | All calculations and statistical analyses were performed using SAS® (version 9.2 or later; SAS Institute, Cary, NC). Numerical efficacy endpoints were tested for significance by analysis of covariance (ANCOVA). The dependent variable was the post-baseline variable; the factor of interest was the UO group, and the value at baseline was the covariate. The baseline value was at visit 2, except for some laboratory tests (e.g. lipid profile, safety parameters) where baseline was at visit 1. The proportion of AE was compared between groups using Fisher’s Exact test or Chi-square test, as appropriate. All statistical tests were performed two-sided, and significance was accepted at the P = 0.05 level. | PMC9882700 |
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Results | The Consolidated Standards for Reporting of Trials (CONSORT) flow diagram shows the progress of the study subjects in | PMC9882700 |
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Adverse events suspected of being related to a product, by group. | PMC9882700 |
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Discussion | A variety of N3PUFA preparations are marketed internationally, varying in biomass source, e.g. fish liver or body oil, krill, or microalgal extracts and concentrates. Among FBO N3PUFA dosage forms displaying high percentages of EPA and DHA, the process of enrichment and concentration often employs transesterification and subsequent re-esterification into triglycerides (rTG). Re-esterification may not be a high fidelity process, resulting in FBO concentrates with variable percentages of rTGs and residual EEs [Several long-term (≥ 12 weeks) studies have described varying bioavailability of EE forms of N3PUFA, relative to rTG forms [These results may be partly explained by differences in the intestinal processing and absorption mechanics of TGs and EEs. Intraluminal digestion, micelle formation, transmembrane transport and enterocyte processing within the endoplasmic reticulum (ER) have been extensively studied and reviewed over the past 5 decades [Digestion and absorption of chemically modified EE LCFA appears to differ from natural dietary TGs or LCFA such as EPA and DHA. Removal of the synthetic ethyl group (CHThe first critique of our study is the modest inequity of daily EPA and DHA dose from each test product, given that the UO group consumed 125 mg more per day of both EPA and DHA than the M3 group. The treatment selection was guided by the intention to compare two bulk oils with high but varying %rTG content. We elected to have the bulk oils encapsulated in the same facility and in an identical manner (antioxidants, flavor, soft-gel capsule size), and to dispense an identical daily capsule count so as to minimize unblinding of both subjects and investigators. Because the %N3PUFA content in M3 was slightly less than in UO, the daily amount of N3PUFA ingested differed marginally between groups. Although this marginal difference would not be expected to drastically change the results, future studies should attempt to more precisely match EPA and DHA levels.Another critique of our study is the absence of dietary n-3 FA intake data collected | PMC9882700 |
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Conclusion | We observed greater increases in EPA- and DHA-containing lipidomic species after 1 and 4 months of supplementation from a higher % rTG FO preparation (UO) containing a very similar amount of EPA and DHA, in young, normolipidemic subjects, in comparison to a lower %rTG FO preparation (Meg-3®). These data suggest that, like EE vs. rTG compositions, % rTGs in rTG FO preparations may evolve as a new chemoprofile/quality control marker that can influence its lipidomic pharmacodynamics. Given the widespread attention to fish oil supplements, and the fact that the global market value for fish oil is estimated to exceed US$23 billion [ | PMC9882700 |
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Supporting information | PMC9882700 |
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CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC9882700 |
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Certificate of analysis for Ultimate Omega®. | (PDF)Click here for additional data file. | PMC9882700 |
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Certificate of analysis for Meg-3®. | (PDF)Click here for additional data file. | PMC9882700 |
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Individual red blood cell fatty acid raw data. | (XLSX)Click here for additional data file. | PMC9882700 |
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Individual serum fatty acid raw data. | (XLSX)Click here for additional data file. | PMC9882700 |
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Protocol. | (PDF)Click here for additional data file.SM was the primary author, and the person responsible for final content.ALA was a co-author and reviewer of the manuscript.JLE was a co-author and reviewer of the manuscript.ML was a co-author and reviewer of the manuscript.JO was a reviewer and provided all essential materials for the study. | PMC9882700 |
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References | PMC9882700 |
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Subject terms | anxiety, pain | Many patients are frightened of or anxious about dental treatment. We have recently reported our use of virtual reality (VR) to alleviate the fear and anxiety experienced during oral surgical procedures However, the effectiveness of VR in alleviating anxiety varies greatly between individuals. We therefore investigated whether the content of the VR presentation made any difference to its effect in alleviating anxiety, and whether it had any analgesic effect. The study subjects experienced one of two different types of VR presentation and were asked to complete a questionnaire about any changes in their anxiety during the procedure, including a visual analog scale (VAS) score. As an objective evaluation, changes in pain threshold during the VR presentation were investigated using PainVision. For those patients who experienced a presentation showing a natural landscape, the change in VAS score was − 13.3 ± 28.7 mm, whereas for those who experienced a presentation showing a video game the change was − 22.2 ± 32.1 mm, an even greater reduction. In a pain questionnaire completed by individuals who had experienced the video game presentations, approximately 70% reported that their pain had diminished. An objective evaluation of pain threshold also showed that the pain threshold of individuals increased by around 3% while experiencing the natural landscape VR presentation, but that while experiencing the video game presentation, it increased significantly by around 15% compared with baseline. These results show that the content of the presentation affected not only the rate of decrease in anxiety, but also the pain threshold. | PMC10665549 |
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Introduction | ADVERSE DRUG EVENTS, COMPLICATIONS | During oral surgery, patients are required to keep their mouths open for a certain period, and the metallic screech of the surgical drill and the unpleasant smell generated by the drilling of hard tissue such as teeth and bone all contribute to a high level of stressVR refers to the techniques and systems used to create an environment that is not itself a physical original, but functions essentially in the same way by stimulating perception, including the user’s five senses. A major advantage of VR is that because it involves almost no physical invasion, potential drug complications or adverse drug events, it may provide a safe method of sedationHowever, problems have also surfaced. The VR experiences that we prepared and presented to patients featured landscapes and animals that were hardly moving, with the aim of inducing relaxation | PMC10665549 |
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Results | Anxiety, anxiety, pain | Table The results of the satisfaction questionnaire are illustrated in Table A comparison of the results of the decreased anxiety questionnaire between the natural landscape VR and video game VR groups showed high rates of decrease in both groups, with 80% of those in the natural landscape VR group and 84% of those in the video game VR group responding that it had either Decreased Substantially or Decreased (Table An investigation of differences between the preoperative and postoperative VAS scores for anxiety and fear found that, as in our previous report, in the non-VR group, the VAS score for anxiety tended to increase postoperatively by 4.0 ± 22.3 mm compared with that preoperatively. In the two VR groups, however, the VAS score decreased significantly compared with the score for the non-VR group. A comparison between the two VR presentations showed that, for those patients who experienced a presentation showing a natural landscape (The results of the pain questionnaire by the patients who experienced the video game presentation were Decreased Substantially 21%, Decreased 47%, Unchanged 32%, Increased Slightly 0%, and Increased 0%, with approximately 70% reporting that their pain had diminished (Table In the investigation of changes in pain threshold using PainVision, the percentage change in current while experiencing the natural landscape VR and the video game VR compared with the value without VR as baseline was calculated. In terms of the mean threshold shift, the threshold increased by around 3% compared with baseline while experiencing the natural landscape presentation. However, while experiencing the video game presentation, it increased significantly by approximately 15% compared with baseline (Fig. Patient demographics.Data bare represented as a mean ± standard deviation of the mean. No significant differences were found between three groups.Response to the satisfaction questionnaire by VR use.Response to the questionnaire on the alleviation of fear and anxiety by VR use.Changes in VAS scores for anxiety. Difference between the preoperative VAS score for anxiety and that during the procedure. Anxiety improved among patients who used VR, whereas it increased in patients who did not use VR. Error bars represent mean ± SD.Response to the questionnaire on the alleviation of pain during treatment by VR use.Changes in pain threshold. Variations in electric current measured by PainVision. The current is compared with the baseline value while the subject was not using VR (none). Error bars represent mean ± SD. | PMC10665549 |
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Discussion | heaviness, anxiety, pain | Many patients are frightened of or anxious about dental treatmentIn a previous study, we demonstrated that the use of VR decreased anxiety and fear of surgical treatment under local anesthesia both subjectively and objectivelyVR is currently in use in several medical fieldsOne point that warrants attention in the experience of VR is cybersicknessA head-mounted display is required to experience VR, but the thickness and heaviness of these displays is an impediment for both operator and patient. It is hoped that smaller, lighter devices will be developed in the future.In a previous study, we showed that most patients who used VR during a surgical procedure expressed the wish to use VR during other such procedures in the futureOur results showed that the use of VR during impacted mandibular third molar extraction under local anesthesia effectively alleviated fear and anxiety during treatment without side effects. They also suggested that pain relief may vary depending on the content of the presentation. VR has potential as a medical assistive device for use during outpatient surgery under local anesthesia. | PMC10665549 |
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Subjects and methods | PMC10665549 |
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Subjects | vertigo | HEART DISEASE | The study population comprised patients who required impacted mandibular third molar extraction in the Department of Oral Surgery of Saga University Hospital between April 2020 and March 2021. For sample size calculation, we used G*Power software (ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany), found that 100 participants (α level = 0.05, the power = 0.95, and the effect size = 0.5) with an actual target of at least 40 per group were suitable for statistical analysis, and a total of 190 participants were recruited. Ten of these patients were excluded because of a history of cybersickness or vertigo, pregnancy, or previous heart disease. The remaining 180 were randomly allocated to one of three groups by the envelope method: a non-VR group, a natural landscape VR group, and a video game VR group. Data were collected from 172 of these patients (66 men and 106 women) who comprised the final study population (Fig. Subject selection. Ten of these patients were excluded because of a history of cybersickness or vertigo, pregnancy, or previous heart disease. The remaining 180 were randomly allocated to one of three groups: a non-VR group (n = 49), a natural landscape VR group (n = 51), and a video game VR group (n = 80). Data were collected from 172 of these patients (66 men and 106 women) who comprised the final study population. | PMC10665549 |
Evaluation method | Anxiety, anxiety, pain | As a subjective evaluation, preoperative and postoperative fear and anxiety were evaluated by a questionnaire that included a visual analog scale (VAS). Anxiety was scored on a scale from “Completely relaxed” at 0 mm to “The most anxious state imaginable” at 100 mm. The post-treatment questionnaire asked patients to evaluate their satisfaction, reduction in anxiety, and change in pain during treatment carried out while experiencing VR on a five-point scale (Table Anxiety and pain questionnaire. | PMC10665549 |
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Surgical technique | tooth | LOCAL INFILTRATION | After local infiltration anesthesia, the patients were placed in a supine position and were fitted with a patient monitor and a head-mounted display (Oculus Go 32 GB, Oculus VR, Menlo Park, CA). Before the impacted third molar extraction started, they experienced a VR presentation for a short period and were asked to confirm that they were not feeling uncomfortable or disturbed. The extractions were conducted by three board-certified oral surgeons. The following procedure is used for the extraction of an impacted third molar. First, a gingival incision is made for extraction. The subperiosteal mucoperiosteal flap is detached and the mandibular cortical bone is clarified. After removing the bone around the impacted wisdom tooth and clarifying the crown of the tooth, the crown and root of the tooth are divided with a cutting bar. After splitting, the crown and root are dislocated and removed respectively. After curettage of the extraction socket, the mucoperiosteal flap is restored to its original position and sutured to complete the procedure.It was explained to the patients that should they feel uncomfortable or disturbed because of the VR during the extraction, the procedure would immediately be halted, and the VR removed. After the extraction was complete, the VR was removed, hemostasis was confirmed, and the procedure was concluded. | PMC10665549 |
VR presentations | All prototype VR software we used for this study was specially developed by the company PR NETWORK Co. (Fukuoka, Japan). The author (YY) owns the copyright of this software. The natural landscape presentation was the presentation used in our previous study. Specifically, the VR reproduced a large film screen either in a cinema or set up outdoors (on a beach or in a garden), on which the images were projected. Natural scenes of animals exhibiting little movement, or of the sea or rivers, were projected onto the screen (Fig. Prepared VR presentations. ( | PMC10665549 |
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Pain threshold measurement | pain | This experiment was conducted on 46 healthy volunteers (9 men and 37 women; mean age 27.0 years). They experienced the VR presentations while lying flat in the same position as the patients who underwent the surgical procedure. Their pain thresholds were measured using a PainVision PS-2100 (Nipro Corporation, Osaka, Japan) to measure the level of electric current perceived as pain | PMC10665549 |
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Analysis method | The data obtained were examined with respect to their variability and showed a normal distribution curve. A | PMC10665549 |
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Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-47764-8. | PMC10665549 |
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Acknowledgements | The author kindly appreciates the precious work of PR NETWORK Co. (Fukuoka, Japan) for VR production. | PMC10665549 |
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Author contributions | Y.Y. designed the study. All authors performed all surgical treatment. R.A. contributed to the statistical analysis. All the authors interpreted data. Y.Y. wrote the manuscript, all authors reviewed the manuscript. | PMC10665549 |
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Data availability | All data generated or analysed during this study are included in this published article and its supplementary information files. | PMC10665549 |
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Competing interests | The authors declare no competing interests. | PMC10665549 |
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References | PMC10665549 |
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Background | lenses, keratoconus | CORNEAL ECTASIA, DISEASE, LENS, KERATOCONUS | Transepithelial corneal crosslinking (CXL) is a novel surgical approach for the treatment of keratoconus, which is a bilateral asymmetrical ophthalmological disease accompanied by progressive corneal ectasia. Silicon hydrogel (SiH) contact lenses have been extensively used in clinical ophthalmologic medicine, as a postoperative ophthalmological intervention. However, the ideal lens application duration after transepithelial CXL remains uncertain. Here, we aimed to investigate the effects and comfort of immediate corneal contact lens use after transepithelial CXL for keratoconus. | PMC10662168 |
Methods | blurred vision, dry, stinging, tearing, pain, corneal edema, conjunctival congestion, keratoconus, photophobia | CORNEAL EDEMA, KERATOCONUS | In this prospective study, 60 patients with keratoconus who underwent transepithelial CXL treatment were enrolled from September 2021 to January 2023 with a male:female ratio of 39:21, and an average age of 25.42 ± 5.47 years. The patients were divided randomly into two groups: group A contained 30 patients wearing silicone hydrogel contact lenses for 7 days postoperatively, and group B contained 30 patients wearing the same contact lenses for 3 days.Ten subjective ophthalmologic symptoms were surveyed by the patients, including pain, photophobia, foreign body sensation, tearing, burning, blurred vision, dry eyes, difficulty opening the eyes, astringency, and stinging. Ophthalmologic signs, including corneal edema and conjunctival congestion, were recorded by a single clinician on postoperative days 1, 3, and 7. | PMC10662168 |
Results | COMPLICATIONS | Each surgical procedure was readily performed without complications, and both groups postoperative day 7 ( | PMC10662168 |
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Conclusions | postoperative ocular distress | Immediate use of silicone hydrogel corneal lenses after transepithelial CXL effectively alleviates postoperative ocular distress, particularly with a three-day use period as the ideal duration. | PMC10662168 |
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Keywords | PMC10662168 |
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Background | postoperative pain, astigmatism, Keratoconus, Corneal crosslinking, lens, keratoconus, photophobia | CORNEAL ECTASIA, DISEASE PROGRESSION, INFILTRATION, ASTIGMATISM, DISEASE, KERATOCONUS, CORNEA, LENS, KERATOCONUS | Keratoconus is a bilateral asymmetrical ophthalmological disease accompanied by progressive corneal ectasia. The major clinical characteristics are substantial thinning and bulging of the cornea, as well as astigmatism to various extents, resulting in a rapid reduction in visual acuity.The prevalence and incidence rates are approximately 1:375, and are distributed globally [Corneal crosslinking (CXL) is regarded as an effective clinical treatment for preventing disease progression [Although the corneal epithelial layer is untouched during transepithelial CXL procedures, topical destruction caused by riboflavin infiltration and UV light exposure may lead to postoperative pain, photophobia, and foreign body sensation in patients [The main component of the silicon hydrogel (SiH) corneal contact lens is silicone hydrogel, containing 38% hydrogen, a diameter of 14 mm, with base curve 8.8 mm, and corneal central thickness of 0.07 mm [The US Food and Drug Administration (FDA) has approved the overnight use or continuous wearing of contact lenses as part of the treatment of keratoconus [Therefore, in this study, we investigated the impact of contact lens application after transepithelial CXL to analyze whether the patient’s overall comfort is related to the duration of lens wearing and to further evaluate patient satisfaction based on the attained ophthalmologic evidence. | PMC10662168 |
Methods | PMC10662168 |
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Study protocol | LENS, GROUP B | After a routine preoperative examination, each surgery was performed by the same experienced senior physician.The surgical procedure was the same as that used in our previous study [Once the surgical procedure was completed, both groups were immediately fixed with AcuVue Oasys SiH contact lenses (Johnson&Johnson, ACUVUE, USA). In terms of postoperative medication use, each patient was provided with Clopito (Santen, Japan) and Flumei drops (Santen, Japan) after surgery, accompanied with a follow up period of 7 days.On the day after the operation, the researcher evaluated the lens condition of each patient using a slit-lamp microscope, including the central position of the lens, any horizontal or vertical lens displacement, degree of lens movement during natural blinking in the original ocular position and upward gaze position, and wettability of the lens. Patients in Group A underwent lens removal at postoperative day 7, whereas those in Group B underwent lens removal after 3 days. | PMC10662168 |
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Postoperative observation | PMC10662168 |
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Subjective symptoms of the operative eye | PMC10662168 |
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Postoperative comfortability | blurred vision, tearing, edema, pain, photophobia | EDEMA | A standard self-administered questionnaire was adopted for both groups to record the postoperative comfort of the ocular area, which was administered on postoperative days 1, 3, 5, and 7. The questionnaire assessed 10 symptoms, including photophobia, tearing, burning, pain, foreign body sensation, blurred vision, difficulty opening the eyes, dry eyes, edema, and sting. Each feature was scored from 0–3, where a score of 0 was considered asymptomatic, and scores of 1, 2, and 3 were rated as mild, moderate, and severe, respectively. The participants received a tutorial regarding the questionnaire, and the completed questionnaires were collected on the day of the re-examination. | PMC10662168 |
Severity of postoperative ocular pain | postoperative ocular pain, pain | The visual analogue scale (VAS) is used to assess the severity of postoperative ocular pain. The VAS for pain is composed of a 10 cm straight line, which is marked with 0 at one end and 10 at the other. A score of 0 represents “no pain,” score 1–3 represents “mild pain,” which does not affect sleeping; score 4–6 is defined as “moderate pain,” which affects night sleep; score 7–10 is regarded as “severe pain,” which severely affects sleeping [ | PMC10662168 |
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Objective signs of the operative eye | conjunctival congestion, corneal edema | EDEMATOUS, CORNEAL EDEMA, CORNEA, LENS |
A single blinded test was applied for corneal edema assessment, where one senior ophthalmologist masked the allocation of the participant’s group while examining the ocular condition of each participant using slit-lamp microscopy. The resulting ocular status was recorded using a score range between 0–3. A higher score represents worse symptoms, where 0 implies a symptom-free cornea and 3 indicates the most edematous cornea. In addition, conjunctival congestion was examined by the same experienced doctor via slit-lamp using the same single blinding method and the ophthalmologic status was recorded. Scoring ranged 0–3, and the higher the score, the worse the conjunctival congestion.Corneal contact lens conditions were also recorded at each examination. | PMC10662168 |
Statistical analysis | The database was established in Excel using SPSS 20.0 statistical software. All the data were tested for homogeneity of variance and sphericity. Further, analysis of variance (ANOVA) and chi-square tests were used for comparison of preoperative basic condition in the two groups, and repeated measures analysis of variance (rANOVA) and one-way ANOVA were used for postoperative comparison between groups; | PMC10662168 |
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Results | LENS, COMPLICATIONS | All surgical procedures were performed smoothly without any complications. In total, 60 patients in groups A and B completed the entire period of lens wearing and observation. | PMC10662168 |
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Adaptability of the Acuvue Oasys contact lens | lens detachment, lens | LENS, CORNEA | The center of the lens was well accommodated as it evenly covered the entire cornea. The degree of horizontal and vertical displacement of the lens center was within 1 mm, and the necessary mobility for lens in situ and upward gazing positions was sufficient, which were 0.61 ± 0.38 mm and 0.88 ± 0.12 mm, respectively. No accidental lens detachment occurred, and the wetness of the lens was ample. | PMC10662168 |
Patient ocular subjective symptom score | PMC10662168 |
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Discussion | ocular pain, corneal dehydration, corneal crosslinking, pain, haze, lens, keratoconus, postoperative corneal edema, dry eye symptoms | INFILTRATION, EPITHELIALIZATION, ADVERSE EFFECTS, LENS, MEIBOMIAN GLAND DYSFUNCTION, KERATOCONUS, DRY EYES SYNDROME | Ensuring patient comfort and satisfaction is a top priority in healthcare systems. Application of bandage contact lens could effectively promote epithelialization and ease the postoperative symptoms after corneal crosslinking [Through rigorous observation, we discovered that it was feasible for patients to remove their lenses only 3 days after the procedure. This finding has the potential to significantly reduce the interval between follow-up visits and increase patient satisfaction, particularly for those traveling from other provinces or suburban areas to receive medical treatment.In subjective ocular assessment, patients in group B, who removed the lens after 3 days, experienced less ocular pain at day 7 with a score of 0.01 ± 0.40 than those in group A, who removed the lens after 7 days with score of 0.12 ± 0.29. As pain is one of the concerning postoperative matters in CXL surgery, the results of the present study could serve as a reliable reference for future keratoconus post-CXL care. In terms of subjective ocular signs, group B displayed lower scoring results than group A in postoperative corneal edema for day 5 and 7, which were 0.10 ± 0.13 and 0.03 ± 0.07, respectively, for group B and 0.17 ± 0.14 and 0.08 ± 0.11, respectively, for group A.Compared with conventional “epi-off” CXL, the corneal epithelium is removed by applying an infiltration enhancer that assists the thorough infiltration of riboflavin into the corneal stroma. The latter method can effectively eliminate the consequent adverse effects caused by the absence of an epithelial layer, such as corneal dehydration, subepithelial haze, and endothelial disruption [In this study, we found that dry eye symptoms lasted the longest among all negative ocular signs. Several studies have demonstrated the correlation between CXL and dry eyes syndrome. In postoperative transepithelial CXL, a marked reduction has been observed in non-invasive tear break-up time (NITBUT), increased ocular surface disease index (OSDI), and impaired meibomian gland dysfunction [This study has several limitations. As the present study was based on the subjective sensations of the participants, each patient’s identity and profile, such as educational background or comprehension ability, could equally influence the results. Further investigations that incorporate more subjective parameters are required. Moreover, tolerance of the lens for these two groups was not examined prior to the intervention, which may have also affected the results of the study.In conclusion, 3 days is regarded as a desirable period for wearing corneal lenses in postoperative trans-epithelial CXL, showing satisfactory results in clinical observation, delivering better ocular sensation, and sufficient visual quality for patients with keratoconus. | PMC10662168 |
Acknowledgements | The funders had no role in the study design, data collection and analysis, decision to publish, or manuscript preparation. | PMC10662168 |
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Authors’ contributions | LL, JFW, XTZ, Study concept and design; LL, LJ, YLD, data collection; ZZ, JFW, data analysis and interpretation; LL, TF, drafting of the manuscript; XTZ, JFW, TH,critical revision of the manuscript; JFW, XTZ, supervision. All authors read and approved the final manuscript. | PMC10662168 |
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Funding | Not pplicable. | PMC10662168 |
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Availability of data and materials | The data used in this study are available from the corresponding author upon request. | PMC10662168 |
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Declarations | PMC10662168 |
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Ethics approval and consent to participate | EYE | This prospective randomized controlled study was approved by the ethics committee of the Eye and ENT Hospital affiliated with the Fudan Institutional Review Board (ethical code KJ2010-18). This study was conducted according to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all participants after a detailed explanation of the study design. | PMC10662168 |
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Consent for publication | Not applicable. | PMC10662168 |
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Competing interests | The authors declare no competing interests. | PMC10662168 |
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References | PMC10662168 |
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Study: | This 16-week trial was performed using a double-blind, placebo-controlled, parallel group design. We aimed to establish whether | PMC10637569 |
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Results: | cedar pollinosis, nasal blockage | All subjects completed the trial. It was conducted during the season when Japanese cedar pollen is most scattered. Serum concentration of Japanese cedar pollen-specific IgE was > 2.0 UA/mL in patients with Japanese cedar pollinosis. The amount of s-IgA in saliva was not increased by NTM048 in overall subjects, and Japanese cedar pollen-specific IgE was not changed by NTM048 in patients with Japanese cedar pollinosis. The symptom of nasal blockage was improved by NTM048 12 weeks after the start of trial. post hoc analysis indicated a positive correlation between improving psychological status and the increase in occupation ratio of lactobacillus including NTM048. | PMC10637569 |
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Conclusion: | nasal blockage | The amount of s-IgA in saliva was not increased by NTM048, but nasal blockage was improved by it. Psychological status might be improved if dosage of NTM048 is raised to the degree that NTM048 might be increased in the intestinal tract. | PMC10637569 |
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2. Materials and methods | PMC10637569 |
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2.1. Participants | cedar pollinosis, pollinosis | HYPERSENSITIVITY SYMPTOMS, POLLINOSIS | We recruited Japanese adult men and women between 20 and 60 years old who could take capsules between November 20, 2017 and December 31, 2017 via Wakayama Medical University. Their eligibility was assessed according to the following exclusion criteria:1) Symptoms of pollinosis other than cedar pollinosis at the time of screening (November 2017 to January 2018).2) Subjects who regularly take probiotics (e.g., lactic acid bacteria beverages, food, and supplements, and/or 3) Smokers.4) Pregnant women, lactating women, or women who want to become pregnant during the trial period.5) Subjects who show hypersensitivity symptoms to lactic acid bacteria foods.6) Subjects who doctors responsible for this study judge to be otherwise unsuitable for inclusion in the trial.JCP-specific IgE levels were measured in all participants after informed consent to inclusion in this study was received. Participants whose JCP-specific serum IgE level was ≥ 0.7 U | PMC10637569 |
2.2. Study design | This sixteen-week trial was performed using a double-blind, placebo-controlled, parallel group design. Participants were asked to take 2 capsules per day as test foods for 16 weeks. The trial was started between January 25, 2018 and February 1, 2018. Participants visited Wakayama Medical University every 4 weeks (0, 4, 8, 12, and 16 weeks). The participants were asked to collect their saliva for 5 minutes with Salivette Cotton (Sarstedt, Nümbrecht, Germany) under an unstimulated condition. After collection of the saliva, all participants answered a questionnaire, | PMC10637569 |
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2.3. Sample size | Sample size was computed based on the primary end-point measurement of s-IgA level on the last day of trial. In a previous report, the difference of mean of s-IgA level between the start and end of trial was 52.2 in a | PMC10637569 |
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2.4. Measurement in blood and stool samples | BLOOD | Blood samples were centrifuged at 1500 g for 10 minutes, and concentrations of JCP-specific IgE in collected serum samples were measured by fluorescence enzyme immune assay (SRL, Tokyo, Japan). Stool samples were collected in spoon-type collection tubes and frozen at −80°C. Concentration of organic anions and short-chain fatty acids in stool samples were measured by liquid chromatography (Techno Suruga Co., Ltd., Shizuoka, Japan). Fecal bacteria were analyzed by Techno Suruga Co., Ltd. using the terminal restriction fragment length polymorphism-based method, according to methods used in a previous study. | PMC10637569 |
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2.4.1. Test foods. | The test foods were capsules containing starch, calcium stearate and microcrystalline cellulose. Probiotic capsules also contained the viable cell count of | PMC10637569 |
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2.4.2. Randomization and masking. | cedar pollinosis | After obtaining written informed consent, we collected the age and sex of the participants. When the number of eligible participants reached 40 in both the healthy subjects and the patients with Japanese cedar pollinosis, these participants were enrolled.In this study, a static allocation table adjusting sex and age (20–40/41–60) was made by the Clinical Study Support Center at Wakayama Medical University Hospital. Participant lists including test ID, subject status (healthy subjects/patients with Japanese cedar pollinosis), age and sex were sent to assignment staff in January 2018, who performed the allocation according to the table. The allocation results were then sent to a facilitator, who labeled the boxes containing test foods according to the results of allocation with ID for testing purposes. The individuals related to the allocation were not connected with the research staff, and all research staff and enrolled participants were unaware of the actual allocations. All data were fixed on October 9,2018, and the allocation key opening was performed. Data were analyzed by a statistician at the Clinical Study Support Center at Wakayama Medical University, according to the statistical analysis plan. | PMC10637569 |
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2.4.3. Statistical analysis. | SECONDARY | Primary outcome was the difference of s-IgA in saliva from start to end of the study (16 weeks after the start). Secondary outcomes were increase in s-IgA in saliva from the start to 4, 8, and 12 weeks after the start, increase in JCP-specific IgE in serum, each POMS2 score and the score of nasal symptoms 4, 8, 12, and 16 weeks after the start. Further secondary outcomes were increase in organic anions and fatty acid levels and the abundance ratio of each bacterium in fecal samples from the start to the end. The score of nasal symptoms and the abundance ratio of each bacterium in fecal samples were analyzed with Wilcoxon test, and other evaluated items were analyzed with Student To examine whether Data were analyzed using SAS 9.4 software (SAS Institute, Cary, NC) for primary and secondary outcomes and JMP Pro 14.1.0 software (SAS Institute) for post hoc analysis. | PMC10637569 |
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