Effectiveness of Web-Based Education on Premenstrual Syndrome and Quality of Life

November 15, 2024 updated by: Sevgi Özkan, Pamukkale University

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

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 evidence-based interventions. The present study aims to fill this gap leveraging technology to deliver targeted information and support to women. For this reason, the purpose of this randomized controlled trial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20160
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PMS (PMSS score of 132+)
  • Normal menstrual cycle (21-35 days)
  • No oral contraceptives
  • No psychiatric problems or treatment
  • Active Internet use
  • Over 18
  • Volunteering to participate in research

Exclusion Criteria:

  • Internet access problems
  • Website login issues
  • Unanswered survey questions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management (especially, non-pharmacologic strategies) for 4 weeks
Behavioral: A web-based education intervention developed for university students with PMS
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.
Other Names:
  • Premenstrual Syndrome Education Program
No Intervention: Control Group
No special intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premenstrual Syndrome Scale (PMSS)
Time Frame: Change from baseline score at 4 and 12 weeks
The scale consists of 44 questions about experiences in the seven days before menstruation. Scores range from 44 to 220, with a total score above 132 indicating the presence of PMS. The scale contains nine subscales, each of which assesses a distinct aspect of PMS-related symptoms.
Change from baseline score at 4 and 12 weeks
Premenstrual Symptoms Impact Scale (PMSIS)
Time Frame: Change from baseline score at 4 and 12 weeks
The scale consists of six questions to evaluate the impact of PMS-related quality of life. Each question assesses the intensity of symptoms experienced during the "last premenstrual period". Total scores range from 6 to 30, with higher scores indicating worsening quality of life.
Change from baseline score at 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: At the end of the 4-week intervention
The scale consists of 10 questions to evaluate user satisfaction with system usability. The total score obtained from the scale is multiplied by 2.5, resulting in a score between 0 and 100. A score of 68 and above indicates that the system is usable.
At the end of the 4-week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal Information Form
Time Frame: Baseline
The form was designed by the researchers to collect students' socio-demographic characteristics and risk factors associated with PMS.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Chair: Ece Özkaradiğin, RN, MSc, Pamukkale University
  • Study Director: Sevgi Özkan, RN, PhD, Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

June 13, 2022

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60116787-020/31827
  • 2020SABE021 (Other Grant/Funding Number: PamukkaleU Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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