## Protocol Section
### Identification Module
**NCT ID:** NCT06431646

**Brief Title:** Effectiveness of Web-Based Education on Symptoms and Quality of Life in University Students With Premenstrual Syndrome

**Official Title:** Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms and Quality of Life

#### Organization Study ID Info
**ID:** 60116787-020/31827
#### Organization
**Class:** OTHER
**Full Name:** Pamukkale University
#### Secondary ID Infos
**Domain:** PamukkaleU Scientific Research Projects Coordination Unit
**ID:** 2020SABE021
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2022-06-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-31

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Pamukkale University

#### Responsible Party

**Investigator Affiliation:** Pamukkale University

**Investigator Full Name:** Sevgi Özkan

**Investigator Title:** Dean of Health Sciences Faculty, Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Digital solutions are becoming increasingly prevalent, addressing health concerns through innovative means has become imperative. Among these concerns, Premenstrual Syndrome (PMS) stands out as a significant challenge that affecting the physical and emotional well-being of women of reproductive age. Despite previous studies demonstrating the effectiveness of health education for PMS, there remains a gap in providing accessible and cost-effective evidence-based interventions. The present study seeks to address this gap by using technology to provide targeted information and support to women. For this reason, the purpose of this randomized controlled study is to evaluate the effectiveness of a web-based health education in university students with PMS. The main questions it aims to answer are:

* Does web-based education lower the premenstrual symptoms in university students with PMS?
* Does web-based education improve the quality of life in university students with PMS?

Researchers compared web-based education to a control (no special intervention) to see if intervention works to management PMS. Intervention group participants received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management strategies for 4 weeks.

**Detailed Description:** The study was planned as a parallel, single-blind, randomized, controlled experimental study with a pretest-posttest design. The sample group of the research was the nursing department of a Faculty of Health Sciences in Pamukkale University. Eligibility was determined by the Premenstrual Syndrome Scale and personal information form. The sample size was calculated in the PS Power and Sample Size Calculations 3.1.6 program by using data from a previous study with a large effect size (α =0.05, d=0.86). Accordingly, it was found that at least 32 participants should be taken for each group to sampling for 80% power. To avoid possible data loss, all participants (n=74) determined to be eligible were included in the study. A simple randomization method was used in this study. Outcomes were measured at baseline, 4 weeks, and 12 weeks after the intervention began. Data were collected using the Premenstrual Syndrome Scale, Premenstrual Symptoms Impact Scale, System Usability Scale, and personal information form.

### Conditions Module

**Conditions:**

- Premenstrual Syndrome

- Quality of Life

**Keywords:**

- Premenstrual Syndrome

- Web-Based

- Nurse-Led

- Health Education

- Quality of Life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized controlled study with a pretest-posttest design

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Student

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 67

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention group received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management (especially, non-pharmacologic strategies) for 4 weeks.

**Intervention Names:**

- Behavioral: A web-based education intervention developed for university students with PMS

**Label:** Intervention Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group received no special intervention.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Group

**Description:** The content of the web-based education program includes the definition, prevalence, importance, causes, symptoms, diagnosis, risk factors, management strategies and treatment options of PMS. The education emphasizes non-pharmacological strategies for managing PMS, including diet, exercise and body mass index (BMI), sleep hygiene, smoking cessation, stress management, as well as vitamin and mineral supplements, herbal therapy, acupuncture, acupressure and reflexology.

**Name:** A web-based education intervention developed for university students with PMS

**Other Names:**

- Premenstrual Syndrome Education Program

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** The form was designed by researchers to collect students' socio-demographic characteristics and factors related to PMS, including menstrual characteristics and associated risk factors.

**Measure:** Personal Information Form

**Time Frame:** Baseline

#### Primary Outcomes

**Description:** The scale consists of 44 questions about to experiences in the week before the menstrual period. The total score ranges from 44 to 220, and above the 132 points indicates the presence of PMS. The nine subscales are as follows: (1) depressive affect, (2) anxiety, (3) fatigue, (4) irritability, (5) depressive thoughts, (6) pain, (7) appetite changes, (8) sleep changes, and (9) swelling.

**Measure:** Premenstrual Syndrome Scale (PMSS)

**Time Frame:** Change from baseline score at 4 and 12 weeks

**Description:** The scale consists of six question to evaluate the impact of premenstrual symptoms on health-related quality-of-life. Each question measures the intensity of symptoms ranging from 1 (no influence) to 5 (severe influence), concerning the "last premenstrual period". The total score ranges from 6 to 30, with higher scores indicating worsening quality of life.

**Measure:** Premenstrual Symptoms Impact Scale (PMSIS)

**Time Frame:** Change from baseline score at 4 and 12 weeks

#### Secondary Outcomes

**Description:** The scale consists of 10 questions to evaluate user satisfaction with the usability of products and systems, including websites. Each question scored between 0 (strongly disagree) and 4 (strongly agree) and the total score obtained is multiplied by 2.5 to obtain a score between 0 and 100. A score of 68 or higher is considered above average and indicates the system is usable.

**Measure:** System Usability Scale (SUS)

**Time Frame:** At the end of the 4-week intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Presence of PMS, defined as a score of 132 and above on the PMSS
* Menstrual cycle within the normal range (21-35 days)
* Not using oral contraceptives
* Not having any psychiatric- related problems or treatment
* Actively using the Internet
* Be over 18 years old
* Volunteering to participate in research

Exclusion Criteria:

* Problems accessing the Internet
* Inability to log into the website
* Non-response to the survey questions

**Gender Based:** True

**Gender Description:** Female students with PMS

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Denizli

**Country:** Turkey

**Facility:** Pamukkale University

**Zip:** 20160

#### Overall Officials

**Official 1:**

**Affiliation:** Pamukkale University

**Name:** Ece Özkaradiğin, RN, MSc

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Pamukkale University

**Name:** Sevgi Özkan, RN, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Management of Premenstrual Syndrome: Green-top Guideline No. 48. BJOG. 2017 Feb;124(3):e73-e105. doi: 10.1111/1471-0528.14260. Epub 2016 Nov 30. No abstract available.

**PMID:** 27900828

**Citation:** Taghizadeh Z, Shirmohammadi M, Feizi A, Arbabi M. The effect of cognitive behavioural psycho-education on premenstrual syndrome and related symptoms. J Psychiatr Ment Health Nurs. 2013 Oct;20(8):705-13. doi: 10.1111/j.1365-2850.2012.01965.x. Epub 2012 Sep 10.

**PMID:** 22957993

**Citation:** Ayaz-Alkaya S, Yaman-Sozbir S, Terzi H. The effect of Health Belief Model-based health education programme on coping with premenstrual syndrome: a randomised controlled trial. Int J Nurs Pract. 2020 Apr;26(2):e12816. doi: 10.1111/ijn.12816. Epub 2020 Jan 27.

**PMID:** 31985138

**Citation:** Simsek Kucukkelepce D, Timur Tashan S. The effects of health belief model-based education and acupressure for coping with premenstrual syndrome on premenstrual symptoms and quality of life: A randomized-controlled trial. Perspect Psychiatr Care. 2021 Jan;57(1):189-197. doi: 10.1111/ppc.12546. Epub 2020 May 29.

**PMID:** 32468669

**Citation:** Borji-Navan S, Mohammad-Alizadeh-Charandabi S, Esmaeilpour K, Mirghafourvand M, Ahmadian-Khooinarood A. Internet-based cognitive-behavioral therapy for premenstrual syndrome: a randomized controlled trial. BMC Womens Health. 2022 Jan 8;22(1):5. doi: 10.1186/s12905-021-01589-7.

**PMID:** 34996424

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008599

- Term: Menstruation Disturbances

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M14167

- Name: Premenstrual Syndrome

- Relevance: HIGH

- As Found: Premenstrual Syndrome

- ID: M11582

- Name: Menstruation Disturbances

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000013577

- Term: Syndrome

- ID: D000011293

- Term: Premenstrual Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
