Effect of Progressive Muscle Relaxation Exercise on Primary Dysmenorrhea Menstrual Symptoms and Quality of Life.
1 other identifier
interventional
42
1 country
1
Brief Summary
In this study, it was aimed to evaluate the effect of progressive muscle relaxation exercise on dysmenorrhea, menstrual symptoms and quality of life in university students with common primary dysmenorrhea. The research is a single center, parallel group block randomized controlled experimental study. This study will be conducted in the Department of Nursing, Faculty of Health Sciences, of a state university in Turkey. The universe of the research will be Gazi University Faculty of Health Sciences, third year and last year nursing students (N: 451). In order to determine the sample size in the research, power analysis was performed using the G Power 3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder Apay (2021), which were similar to our study, were taken as reference. According to the power analysis made by calculating the effect size; It was determined that the sample of the study should consist of a total of 42 people, 21 in each group, will be randomized. The data of the research; Personal information form will be collected using Visual Analogue Scale (VAS), SF-12 Quality of Life Scale Short Form, Menstrual Symptom Scale, Dysmenorrhea Monitoring Form. The implementation of the research is planned between April 15, 2022 and August 15, 2022. Third and fourth year nursing students will be included in the study. First of all, it will be evaluated according to the sampling inclusion criteria using the pre-evaluation form. Women who meet the inclusion criteria will be informed about the purpose and importance of the research, and women who agree to participate in the study will be determined. Informed consent form will be signed by the women who accepted to participate in the study, Visual Analogue Scale, Menstrual Symptom Scale and SF 12 Short Form will be applied. Randomization will be done after obtaining consent and filling out the forms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedApril 21, 2022
April 1, 2022
4 months
March 30, 2022
April 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change difference primary dysmenorrhea of the groups
Visual Analog Scale
8 weeks
change difference between the menstrual symptom scale scores of the groups
menstrual symptom scale
8 weeks
Study Arms (2)
experimental group
EXPERIMENTALThis group will practiced progressive muscle relaxation exercise
control group
NO INTERVENTIONThis group will not practiced progressive muscle relaxation exercise
Interventions
In the application, "Relaxation Exercises CD Audio Recordings" prepared by the Turkish Psychological Association were used. In the the second part of 30 minutes were explained with the sound of the PKGE stream and verbal instructions. Audio recordings in the second part were used in this study. In line with the PCGE sound recordings, each muscle group starting from the hands to the feet, and then the facial and whole body muscles were stretched for about 10 seconds. The exercise was applied by taking deep breaths while tensing each muscle group, and releasing this breath slowly during relaxation. The relaxation lasted 10-20 seconds before the next muscle group was stretched. In this way, the muscles groups in the hands, arms, neck, shoulders, chest, abdomen, hips, feet and fingers, face and whole body were voluntarily stretched and relaxed, respectively, and the students were relaxed.
Eligibility Criteria
You may qualify if:
- Having primary dysmenorrhea,
- Being Nulligravida,
- Having a history of regular menstrual cycles in the last six months (cycle duration 21-35 days),
- Not using hormonal contraceptives,
- A score of 5 or more on the visual analog scale (VAS).
- Not to have metabolic disease, cancer, heart disease and diabetes, diagnosed psychiatric disease, and not using antidepressant medication that would prevent him from performing PCGE.
- Not doing any other body-mind based practice
- Using a smartphone
- Not having any communication problems (mental, auditory, visual, etc.)
You may not qualify if:
- Use of complementary therapies, anti-inflammatory therapy, antidepressants or anxiolytics during the study
- Occurrence of menstrual cycle irregularity
- Performing PKGE 3 times a week or less in a row
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Sıdıka PELİT AKSU
Ankara, Turkey/Ankara, 06500, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sıdıka PELİT AKSU, PhD
Gazi University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research asistant (RN)
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 21, 2022
Study Start
April 15, 2022
Primary Completion
August 15, 2022
Study Completion
September 15, 2022
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share