- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05396976
The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Premenstrual Syndrome
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arzu Abic
- Phone Number: 05488506060
- Email: arzu.abic@emu.edu.tr
Study Contact Backup
- Name: Sinem Dag Canatan, MsC
- Email: sinem.dag@emu.edu.tr
Study Locations
-
-
-
Famagusta, Cyprus
- Eastern Mediterranean University
-
Contact:
- Arzu Abiç, PhD
- Phone Number: 05488506060
- Email: arzu.abic@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
no intervention
|
|
|
Experimental: Yoga Group
Yoga practice 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.
|
|
Experimental: Muscle Relaxation Exercise Practices Group
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.
|
|
Experimental: Yoga and Muscle Relaxation Exercise Practices Group
Yoga and 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Premenstrual Syndrome Scale
Time Frame: 10 weeks
|
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.
|
10 weeks
|
|
Depression Anxiety Stress Scale-21
Time Frame: 10 weeks
|
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.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arzu Abiç, PhD, Eastern Mediterranean University
- Principal Investigator: Sinem Dağ Canatan, MsC, Eastern Mediterranean University
- Principal Investigator: Aslı Er Korucu, PhD, Ankara University
- Principal Investigator: Ahu Aksoy Can, PhD, Mersin University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETK00-2022-0100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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