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The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Relaxation Exercises
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome, Exercises, Women Health

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kütahya Health Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2022
Last Updated
February 10, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05428800
Brief Title
The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms
Official Title
The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Syndrome, Exercises, Women Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Masking Description
No Masking
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Relaxation Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
intervention applied to the experimental group
Description
At the end of 8 weeks of progressive relaxation exercises, improvement in premenstrual syndrome symptoms of the experimental group is expected.
Time Frame
It includes an 8-week process.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The research was conducted with women between the ages of 18-35.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kütahya Health Science University
City
Kütahya
ZIP/Postal Code
43000
Country
Turkey

12. IPD Sharing Statement

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The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms

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