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Premenstrual SyndromeNCT06431646

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

A study testing A web-based education intervention developed for university students with PMS in people with Premenstrual Syndrome and Quality of Life, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Premenstrual Syndrome, Quality of Life
What is being tested?
A web-based education intervention developed for university students with PMS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2022to 13 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Pamukkale University

    Denizli, Denizli, 20160

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms 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.

Read the 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.

Being tested
A web-based education intervention developed for university students with PMS
Keywords
Premenstrual Syndrome, Web-Based, Nurse-Led, Health Education, Quality of Life
Medical subject headings
Premenstrual Syndrome, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A web-based education intervention developed for university students with PMSBehavioural

    Also called Premenstrual Syndrome Education Program

    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.

Study groups in NCT06431646
Study groupRoleWhat they receive
Intervention GroupExperimentalWeb-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management (especially, non-pharmacologic strategies) for 4 weeks
Receives: Behavioral: A web-based education intervention developed for university students with PMS
Control GroupNo interventionNo special intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline score at 4 and 12 weeks

  2. 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.

    Measured: Change from baseline score at 4 and 12 weeks

Secondary outcomes (1)

  1. System Usability Scale (SUS)

    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.

    Measured: At the end of the 4-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start1 Jan 2022
  3. Primary completion31 Mar 2022
  4. Study completion13 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled study with a pretest-posttest design
Masking
Single blind
Who is masked
Participant
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431646
Sponsor's protocol ID
60116787-020/31827
Other IDs
2020SABE021
Status last verified
May 2024
First submitted
15 May 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27900828

  • 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.

    PubMed 22957993

  • 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.

    PubMed 31985138

  • 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.

    PubMed 32468669

  • 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.

    PubMed 34996424

Questions about this trial

What is this clinical trial studying?

A study testing A web-based education intervention developed for university students with PMS in people with Premenstrual Syndrome and Quality of Life, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Premenstrual Syndrome Scale (PMSS) (time frame: Change from baseline score at 4 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06431646, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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