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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06431646
Enrollment
67
Registered
2024-05-28
Start date
2022-01-01
Completion date
2022-06-13
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome, Quality of Life

Keywords

Premenstrual Syndrome, Web-Based, Nurse-Led, Health Education, Quality of Life

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.

Interventions

BEHAVIORALA 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.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Student

Intervention model description

Randomized controlled study with a pretest-posttest design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Premenstrual Syndrome Scale (PMSS)Change from baseline score at 4 and 12 weeksThe 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)Change from baseline score at 4 and 12 weeksThe 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

MeasureTime frameDescription
System Usability Scale (SUS)At the end of the 4-week interventionThe 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

MeasureTime frameDescription
Personal Information FormBaselineThe form was designed by the researchers to collect students' socio-demographic characteristics and risk factors associated with PMS.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026