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

NCT ID: NCT06431646

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-06-13

Brief Summary

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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

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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.

Conditions

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Premenstrual Syndrome Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study with a pretest-posttest design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Student

Study Groups

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Intervention Group

Web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management (especially, non-pharmacologic strategies) for 4 weeks

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control Group

No special intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Premenstrual Syndrome Education Program

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Sevgi Özkan

Dean of Health Sciences Faculty, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ece Özkaradiğin, RN, MSc

Role: STUDY_CHAIR

Pamukkale University

Sevgi Özkan, RN, PhD

Role: STUDY_DIRECTOR

Pamukkale University

Locations

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Pamukkale University

Denizli, Denizli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27900828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22957993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31985138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32468669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34996424 (View on PubMed)

Other Identifiers

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2020SABE021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

60116787-020/31827

Identifier Type: -

Identifier Source: org_study_id

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