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The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Premenstrual Syndrome

Primary Purpose

Premenstrual Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Yoga and Muscle Relaxation Exercise Practices
Sponsored by
Eastern Mediterranean 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, Yoga, Muscle Relaxation Exercise Practices, Depression, anxiety and stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Filling the data collection tools and not having an obstacle that would cause communication difficulties in the interviews Having a score of 110 or more from the PMS scale in the data collection form Voluntary consent to participate in the study Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days), Being a second and third year nursing student be over 18 years old

Exclusion Criteria:

Receiving medical treatment for PMS Being pregnant or having experienced pregnancy before Having a systemic or chronic disease No physical or mental health problems that prevent exercise

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Experimental

Arm Label

Yoga Group

control group

Muscle Relaxation Exercise Practices Group

Yoga and Muscle Relaxation Exercise Practices Group

Arm Description

Yoga practice will be done two days a week for 10 weeks.

no intervention

Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.

Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.

Outcomes

Primary Outcome Measures

Premenstrual Syndrome Scale
Premenstrual syndrome scale is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms by Gençdoğan (2006). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points.
Depression Anxiety Stress Scale-21
The DASS-21 scale, which is an abbreviated version of DASÖ-42 developed by Lovibond and Lovibond in 1995, was used. The 21-item short form (DASS-21) of the scale was adapted to Turkish by Sarıçam in 2018 in normal and clinical samples. The scale is a 4-point Likert-type scale and includes 21 questions in total, 7 questions each to measure the dimensions of depression, anxiety and stress.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
May 27, 2022
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05396976
Brief Title
The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Premenstrual Syndrome
Official Title
The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Menstrual Symptoms, Depression, Anxiety and Stress in University Students: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean 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
Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Despite the conclusion that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.
Detailed Description
Menstrual cycle is defined as hormonal and physical changes that continue from menarche to menopause, affecting the whole organism, especially the reproductive organs. During this period, which is necessary for the normal continuation of female reproductive functions and occurs periodically every month, women encounter many menstrual problems. Premenstrual syndrome (PMS), one of the most common problems, is defined as the changes that are associated with the luteal phase of the menstrual cycle and that affect a woman's life in a regular and cyclical way, physically, emotionally and behaviorally.It is stated that PMS, which is very common in the society, affects close family relations, social life, work performance and work relations. The most common symptoms are; muscle, stomach and headache, breast tenderness, weight gain, intense desire for certain foods, appetite change, acne, edema, fatigue, mood swings, emotionality, irritability. It is known that the mental health of women who are physiologically affected by PMS will also be affected by the syndrome and bring along mental problems. Schmelzer stated in his study that the emergence of depressive thoughts and emotions in the premenstrual period is one of the most common PMS symptoms. In many studies examining the relationship between mental health and PMS, it has been found that there is a positive and significant relationship between PMS and depression level. One of these studies, Uran et al., in a study conducted with 55 people with an average age of 15, stated that the most common psychological factors accompanying PMS were irritability and anger level. As can be seen, PMS has negative effects on both mental health and physical health. Although many areas of women with PMS are negatively affected in their daily lives and its incidence is high, very few of them receive professional help and medical care. At the same time, their quality of life is also declining. It is known that women often resort to non-pharmacological methods instead of receiving professional health care, since PMS is considered to be a physiologically normal condition with a traditional point of view.In addition, undesirable effects of medical treatments in coping with PMS are not preferred by women because they bring many health risks. Women can use many non-invasive and risk-free integrated treatment methods (such as heat treatments, exercise, aromatherapy, phytotherapy, Transcutaneous Electrical Nerve Stimulation, acupuncture, acupressure, yoga, progressive relaxation exercises, massage, relaxation techniques, reflexology, reiki) in coping with PMS. ) are more oriented. One of these methods, yoga, is a practice that includes deep breathing, meditation, stretching exercises and posture poses based on the unity of mind and body. It is emphasized that yoga exercises reverse the negative effects of stress on the immune system, improve inflammatory processes, reduce symptoms such as pain and insomnia, and improve quality of life, thanks to the balance, stretching, relaxation and strengthening components.In Yang and Kim's study with undergraduate nursing students with primary dysmenorrhea, a 60-minute yoga program was applied once a week for 12 weeks. As a result of the study, it was determined that menstrual pain decreased significantly in the intervention group compared to the control group. Yonglitthipagon et al. found that yoga exercise applied to women with primary dysmenorrhea between the ages of 18-22 for 30 minutes twice a week for 12 weeks reduced menstrual pain and increased physical fitness and quality of life. It has also been reported in studies that progressive relaxation exercises have a reducing effect on depression, stress and anxiety. Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Although it is concluded that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Syndrome, Yoga, Muscle Relaxation Exercise Practices, Depression, anxiety and stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
Yoga practice will be done two days a week for 10 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention
Arm Title
Muscle Relaxation Exercise Practices Group
Arm Type
Experimental
Arm Description
Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.
Arm Title
Yoga and Muscle Relaxation Exercise Practices Group
Arm Type
Experimental
Arm Description
Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga and Muscle Relaxation Exercise Practices
Intervention Description
Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.
Primary Outcome Measure Information:
Title
Premenstrual Syndrome Scale
Description
Premenstrual syndrome scale is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms by Gençdoğan (2006). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points.
Time Frame
10 weeks
Title
Depression Anxiety Stress Scale-21
Description
The DASS-21 scale, which is an abbreviated version of DASÖ-42 developed by Lovibond and Lovibond in 1995, was used. The 21-item short form (DASS-21) of the scale was adapted to Turkish by Sarıçam in 2018 in normal and clinical samples. The scale is a 4-point Likert-type scale and includes 21 questions in total, 7 questions each to measure the dimensions of depression, anxiety and stress.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female students over the age of 18
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Filling the data collection tools and not having an obstacle that would cause communication difficulties in the interviews Having a score of 110 or more from the PMS scale in the data collection form Voluntary consent to participate in the study Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days), Being a second and third year nursing student be over 18 years old Exclusion Criteria: Receiving medical treatment for PMS Being pregnant or having experienced pregnancy before Having a systemic or chronic disease No physical or mental health problems that prevent exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arzu Abic
Phone
05488506060
Email
arzu.abic@emu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Sinem Dag Canatan, MsC
Email
sinem.dag@emu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Abiç, PhD
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sinem Dağ Canatan, MsC
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aslı Er Korucu, PhD
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahu Aksoy Can, PhD
Organizational Affiliation
Mersin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
Country
Cyprus
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arzu Abic, PhD
Phone
05488506060
Email
arzu.abic@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/22830969/
Description
Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results.
URL
http://pubmed.ncbi.nlm.nih.gov/27315239/
Description
Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial

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The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Premenstrual Syndrome

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