NCT06208670

Brief Summary

Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence. Materials and Methods: The research was planned as an experimental study with a pretest-posttest control group, with female patients coming for examination at Siirt Training and Research Hospital Gynecology Polyclinics between December 2023 and August 2024. "Personal Information Form, Premenstrual Syndrome Scale and Violence Tendency Scale" were used to collect data in the study. Percentage distributions and t-test in independent groups were used to evaluate the data.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 22, 2023

Last Update Submit

January 18, 2024

Conditions

Keywords

Premenstrual Syndrome SymptomsTendency to ViolenceProgressive Muscle Relaxation Exercises

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Syndrome Scale

    The premenstrual Syndrome Scale (PMSS) was developed by Başaran GENÇDOĞAN in 2006. The scale consists of 44 items in a 5-point Likert type (never, very rarely, sometimes, frequently, continuously). In the scoring of the scale, 1= never, 2= very rarely, 3= sometimes, 4= frequently, 5= continuously. A minimum score of 44 and a maximum score of 220 can be obtained from the scale. The reliability of the PMSQ was determined by test-retest and internal consistency methods. The reliability of the scale is Cronbach's alpha 0,75. (Gençdoğan, 2006).

    Six month

Secondary Outcomes (1)

  • The Violence Tendency Scale

    Six month

Study Arms (2)

Progressive Muscle Relaxation Exercises

EXPERIMENTAL

Progressive Relaxation Exercises (PGE) Practice: The importance and benefits of PGE exercises, situations to be avoided during the exercise, and the process of teaching by practicing and practicing the exercise will be done by the trained researcher for eight weeks, and it will be ensured that they repeat it at home. Progressive relaxation exercise instructions and a practical demonstration of the researcher will be made with the directives in the audio video with music. During the relaxation exercises, individuals will first intentionally tighten the muscle groups in the hands, arms, neck, shoulders, face, chest, abdomen, buttocks, feet, and fingers (muscle groups starting from the hands and ending with the feet) and then relax the muscles according to the commands on the CD.

Behavioral: Progressive muscle relaxation exercises

Violent tendency Scale

EXPERIMENTAL

was developed to identify aggression and violence tendencies

Behavioral: Violent tendency Scale

Interventions

PMI is among the non-pharmacological methods nurses can offer caregivers (Yılmaz et al., 2019). Health professionals, especially nurses, should evaluate all women of reproductive age in terms of PMS, plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, support the planned educational interventions through written or visual materials, provide effective and quality counseling services, and aim to improve women's decreased quality of life (Abay \& Kaplan 2019; Aksoy Derya et al. 2019; Akmalı et al. 2020). Women can be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo \& Dahn, 2005; ACOG, 2015; Khajehei 2015).

Progressive Muscle Relaxation Exercises

Violent tendency Scale

Violent tendency Scale

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe reason why we included only female subjects in our study is that we studied premenstrual syndrome as a subject.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study,
  • years old,
  • At least primary school graduate,
  • Scored 110 and above on the Premenstrual Syndrome Scale,
  • Menstrual cycle length for the last three months is within normal limits (21-35),
  • Women who have not used oral contraceptives for the last three months.

You may not qualify if:

  • Having a physical or mental illness that would prevent participation in the study,
  • Women who score below 110 points on the Premenstrual Syndrome Scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Education Research Hospital

Siirt, Centrum, 56100, Turkey (Türkiye)

Location

Related Publications (1)

  • Togluk S, Gul S. The effects of progressive muscle relaxation exercises on premenstrual syndrome symptoms and violence tendencies in women: a randomized controlled trial. BMC Womens Health. 2025 Apr 12;25(1):176. doi: 10.1186/s12905-025-03712-4.

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sidar GÜL, PhD

    SİİRT UNIVERSITY

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 17, 2024

Study Start

January 15, 2024

Primary Completion

March 15, 2024

Study Completion

August 15, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Once our study is finalized, it is planned to be published in an international journal.

Shared Documents
SAP, CSR
Time Frame
The data will be made available at the end of the study and there will be no restrictions on use.
Access Criteria
Attribution Use for scientific purposes

Locations