Clinical trial NCT06431646: Effectiveness of Web-Based Education on Premenstrual Syndrome and Quality of Life
Official title: Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Quality of Life
Keywords: Premenstrual Syndrome
Web-Based
Nurse-Led
Health Education
Quality of Life
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study with a pretest-posttest design
Primary purpose: SUPPORTIVE_CARE

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.

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
* Over 18
* Volunteering to participate in research

Exclusion Criteria:

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

Primary outcomes:
measure: Premenstrual Syndrome Scale (PMSS)
timeFrame: Change from baseline score at 4 and 12 weeks
measure: Premenstrual Symptoms Impact Scale (PMSIS)
timeFrame: Change from baseline score at 4 and 12 weeks
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: At the end of the 4-week intervention
Other outcomes:
measure: Personal Information Form
timeFrame: Baseline
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Ece Özkaradiğin, RN, MSc
role: STUDY_CHAIR
affiliation: Pamukkale University
name: Sevgi Özkan, RN, PhD
role: STUDY_DIRECTOR
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.
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.
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.
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.
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.