- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296043
The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome
March 29, 2024 updated by: Saglik Bilimleri Universitesi
The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Various medications can be used to relieve PMS symptoms, but there is no treatment to completely eliminate it.
For this reason, women may seek traditional and alternative practices to reduce PMS complaints.
Alternative methods such as herbal treatment, aromatherapy, acupuncture, nutrition regulation and stress control can be used to relieve PMS symptoms.
It has been stated that applying mind-body based therapies to relieve PMS symptoms is safe and cost-effective.
Such interventions include progressive muscle relaxation exercise (PCGE), paced breathing, clinical hypnosis, yoga, mindfulness, reflexology, and cognitive behavioral therapies.
Su-Jok application, which is an alternative method, can also be used to relieve PMS symptoms.
In Su-Jok therapy, the practitioner stimulates points on the hands and feet to activate auto-regulatory mechanisms and bring the body to a healthy state.
Due to the negative effects of PMS on daily life, knowing the frequency of occurrence and risk factors is expected to contribute and guide individuals in coping with PMS.
While PMS threatens the health of the individual in particular, it generally brings socio-economic burdens to the individual, family and society.
Study Type
Interventional
Enrollment (Estimated)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Filiz Ünal Toprak, PhD
- Phone Number: 05077732090
- Email: filizore1@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Getting over 104 points from the PMS scale,
- Having regular menstruation,
- Not having any chronic disease,
- Not using any method to cope with PMS.
Exclusion Criteria:
- Having irregular menstruation,
- Having musculoskeletal system and respiratory diseases,
- Having a diagnosed psychiatric disease,
- Having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
No application will be made to this group by the researcher.
|
|
Experimental: Progressive Muscle Relaxation Exercise Group
Application will be made on the day PMS symptoms begin and throughout the menstrual cycle.
|
Exercise Group
|
Experimental: Su-Jok Group
Application will be made on the day PMS symptoms begin and throughout the menstrual cycle.
|
Hand massage with seeds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time Frame: 3 months
|
In the 1st, 2nd and 3rd month menstrual periods;
|
3 months
|
FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time Frame: 3 months
|
In the 1st, 2nd and 3rd month menstrual periods;
|
3 months
|
SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time Frame: 3 months
|
In the 1st, 2nd and 3rd month menstrual periods;
|
3 months
|
NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time Frame: 3 months
|
In the 1st, 2nd and 3rd month menstrual periods;
|
3 months
|
Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined).
Time Frame: 3 months
|
In the 1st, 2nd and 3rd month menstrual periods;
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Filiz Ünal Toprak, PhD, Saglik Bilimleri Universitesi
- Principal Investigator: Sevil Albayrak, PhD, Cyprus Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 10, 2024
Primary Completion (Estimated)
July 15, 2024
Study Completion (Estimated)
August 15, 2024
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 28, 2024
First Posted (Actual)
March 6, 2024
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU-FUT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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