The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome

June 6, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Sağlık Bilimleri Üniversitesi
        • Contact:
          • Filiz Ünal Toprak, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Progressive Muscle Relaxation Exercise Group
Exercise Group
Experimental: Su-Jok Group
Application will be made on the day PMS symptoms begin and throughout the menstrual cycle.
Procedure: Su-Jok Intervention
Hand massage with seeds

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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;

  • Premenstrual Syndrome Scale
  • VAS evaluation scale will be applied.
3 months
FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time Frame: 3 months

In the 1st, 2nd and 3rd month menstrual periods;

  • Premenstrual Syndrome Scale
  • VAS evaluation scale will be applied.
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;

  • Premenstrual Syndrome Scale
  • VAS evaluation scale will be applied.
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;

  • Premenstrual Syndrome Scale
  • VAS evaluation scale will be applied.
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;

  • Premenstrual Syndrome Scale
  • VAS evaluation scale will be applied.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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