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NCT Number: NCT06431646

Effectiveness of Web-Based Education on Premenstrual Syndrome 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.

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Key information

Conditions

Premenstrual Syndrome Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Quality of Life Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 28, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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