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

NCT06431646 | Completed

• 2 other identifiers: 60116787-020/318272020SABE021
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Premenstrual Syndrome Scale (PMSS)

  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)

  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 Outcomes (1)

• System Usability Scale (SUS)

  At the end of the 4-week intervention

Other Outcomes (1)

• Personal Information Form

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No special intervention

Interventions

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.

Also known as: Premenstrual Syndrome Education Program

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female students with PMS
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Denizli, 20160, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27900828 BACKGROUND

• 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.

  PMID: 22957993 BACKGROUND

• 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.

  PMID: 31985138 BACKGROUND

• 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.

  PMID: 32468669 BACKGROUND

• 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.

  PMID: 34996424 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Health Education

Interventions

Spectrometry, Fluorescence

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis

Study Officials

• Ece Özkaradiğin, RN, MSc

  Pamukkale University

  STUDY CHAIR

• Sevgi Özkan, RN, PhD

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Student
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Health Sciences Faculty, Professor

Model Details: Randomized controlled study with a pretest-posttest design

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 28, 2024
• Study Start: January 1, 2022
• Primary Completion: March 31, 2022
• Study Completion: June 13, 2022
• Last Updated: November 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)