NCT06909955

Brief Summary

This study results will provide evidence on the effectiveness of Progressive Muscle Relaxation Exercises (PMRE) as a complementary method in improving Premenstrual Syndrome (PMS), an important women's health issue. Additionally, it will contribute to the literature by shedding light on irritability and anxiety, which are common side effects of PMS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet 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 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 27, 2025

Last Update Submit

March 27, 2025

Conditions

Keywords

premenstrual syndromeprogressive relaxation exercise

Outcome Measures

Primary Outcomes (3)

  • Premenstrual Syndrome Scale

    Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this scale consists of 44 items in a five-point Likert format, with response options scored from 1 to 5.

    evaluations will be conducted at the day 1 and after 8 weeks.

  • Violence Tendency Scale

    Violence Tendency Scale (VTS): Developed by Göka, Bayat, and Türkçapar (1995) for the Ministry of National Education to assess violence tendencies in secondary school students, the scale was later redesigned and validated in the Prime Ministry Family Research Institution's 1998 study on violence in family and society.

    evaluations will be conducted at the day 1 and after 8 weeks.

  • Beck Anxiety Inventory

    Beck Anxiety Inventory (BAI): Developed by Beck and colleagues in 1988, the Beck Anxiety Inventory (BAI) consists of 21 items and follows a Likert-type (0-3) self-report format (Beck, Brown, Epstein, \& Steer, 1988).

    evaluations will be conducted at the day 1 and after 8 weeks.

Study Arms (2)

Exercise group

EXPERIMENTAL
Other: Exercise

Control group

NO INTERVENTION

Interventions

Relaxation Exercises (Progressive Muscle Relaxation Exercises): Progressive muscle relaxation exercises, one of the relaxation techniques, will be used in this study. Participants will be instructed to sit in a comfortable position on a chair during the exercises. Clear and precise instructions will be provided to ensure proper execution. The exercise program will be conducted for 8 weeks, 3 days a week, for 30 minutes, under the supervision of an expert physiotherapist.

Exercise group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly femle persons will accept
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female students studying at Istanbul Aydın University, Faculty of Health Sciences, Those who score 111 or above on the Premenstrual Syndrome Scale (PMSS), Female students aged 18-24 will be included in the study.

You may not qualify if:

  • Non-Turkish speakers, Individuals who cannot communicate normally, Students who are unable to comply with the exercise program will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premenstrual Dysphoric DisorderPremenstrual Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

February 27, 2025

First Posted

April 4, 2025

Study Start

April 1, 2025

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

April 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share