NCT06296043

Brief Summary

The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

June 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 12, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Premenstrual SyndromeNursingSu-JokProgressive muscle relaxation exercise

Outcome Measures

Primary Outcomes (5)

  • PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10)

    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)

    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)

    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)

    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).

    In the 1st, 2nd and 3rd month menstrual periods; * Premenstrual Syndrome Scale * VAS evaluation scale will be applied.

    3 months

Study Arms (3)

Progressive Muscle Relaxation Exercise Group

EXPERIMENTAL

Application will be made on the day PMS symptoms begin and throughout the menstrual cycle.

Procedure: Progressive Muscle Relaxation Exercise Group

Su-Jok Group

EXPERIMENTAL

Application will be made on the day PMS symptoms begin and throughout the menstrual cycle.

Procedure: Su-Jok Intervention

Control Group

NO INTERVENTION

No application will be made to this group by the researcher.

Interventions

Exercise Group

Progressive Muscle Relaxation Exercise Group

Hand massage with seeds

Su-Jok Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince it is a study conducted on premenstrual symptoms with women, it concerns the female gender.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Getting over 104 points from the PMS scale,
  • Having regular menstruation,
  • Not having any chronic disease,
  • Not using any method to cope with PMS.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Filiz Ünal Toprak, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • Sevil Albayrak, PhD

    Kıbrıs İlim Üniversitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Filiz Ünal Toprak, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Double (Participant, Outcomes Assessor) Since the application will be performed by the researcher, participant will be blinded in this study. The statistician will be blinded in the evaluation of the data.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Three groups with su-jok group, progressive muscle relaxation exercise group and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

March 6, 2024

Study Start

April 10, 2024

Primary Completion

July 15, 2024

Study Completion

August 15, 2024

Last Updated

June 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations