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Clinical Trials/NCT06431646
NCT06431646
Completed
Not Applicable

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

Pamukkale University1 site in 1 country67 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premenstrual Syndrome
Sponsor
Pamukkale University
Enrollment
67
Locations
1
Primary Endpoint
Premenstrual Syndrome Scale (PMSS)
Status
Completed
Last Updated
last year

Overview

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 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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 13, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sevgi Özkan

Dean of Health Sciences Faculty, Professor

Pamukkale University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • System Usability Scale (SUS)(At the end of the 4-week intervention)

Study Sites (1)

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