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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05428800
Other study ID # E-41997688-050.99-43313
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date December 30, 2022

Study information

Verified date February 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. Participant information form and premenstrual syndrome scale will be used in the research. There are two groups in the study as experimental (n=40) and control (n=40).


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Progressive Relaxation Exercises
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.

Locations

Country Name City State
Turkey Kütahya Health Science University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary intervention applied to the experimental group At the end of 8 weeks of progressive relaxation exercises, improvement in premenstrual syndrome symptoms of the experimental group is expected. It includes an 8-week process.
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