- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428800
The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms
The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Institutional permission and ethics committee approval were obtained for the research. The population of the study consisted of 218 women. The sample of the study consisted of 80 women, 40 of which were experimental and 40 control. Participants were evaluated according to the www.randomizer.org program and randomization was achieved among the women participating in the study.
The research process and the participants in the experimental and control groups will be explained again and the necessary equipment will be provided by the researchers. The "Progressive Relaxation Exercises Guide" prepared by the researcher in accordance with the literature will be given to the women in the experimental group (40), taking the opinions and suggestions of eight experts. At the same time, the comprehensibility and applicability of the guide were evaluated by making a pilot application to 10 women before the research. Afterwards, all the information in the guide will be explained to the women in the experimental group and training will be given until adequate feedback is received. At the same time, progressive relaxation exercises belonging to the Turkish Psychological Association were given to the women in CD form, and listening to the audio recordings together with the relaxation exercises to be performed in accordance with the guide will be indicated. These exercises will be performed by the women in the experimental group for 25-30 minutes a day, every day for 8 weeks. At the end of 8 weeks, women will be reassessed with PMSS. The women in the control group (40) will be told to continue their routine habits regarding PMS in parallel with the study group, without any application. At the end of 8 weeks, women in the control group will be re-evaluated with PMSS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kütahya, Turkey, 43000
- Kutahya Health Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being between 18-35 years old, single marital status,
- Willingness and volunteering to work,
- Being able to read and write in Turkish and understand what he reads,
- Applying to the obstetrics and gynecology outpatient clinic for routine control,
- Getting a score of 110 and above in PMSS.
Exclusion Criteria:
- The woman has an obstetric or medical health problem that prevents her from doing progressive relaxation exercises,
- Having a chronic and gynecological health problem,
- Regular exercise,
- There is a change in menstrual characteristics in the last six months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Experimental
Progressive relaxation exercises will be performed for 25-30 minutes every day for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS.
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Progressive muscle relaxation (PMR) is a relaxation technique that tenses and relaxes muscles in an unprompted, regular, and consecutive manner until the whole body is relaxed.
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NO_INTERVENTION: Control
They will continue their routine coping habits for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intervention applied to the experimental group
Time Frame: It includes an 8-week process.
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At the end of 8 weeks of progressive relaxation exercises, improvement in premenstrual syndrome symptoms of the experimental group is expected.
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It includes an 8-week process.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-41997688-050.99-43313
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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