NCT05428800

Brief Summary

The aim of this study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. Participant information form and premenstrual syndrome scale will be used in the research. There are two groups in the study as experimental (n=40) and control (n=40).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

June 9, 2022

Last Update Submit

February 10, 2023

Conditions

Keywords

Premenstrual Syndrome, Exercises, Women Health

Outcome Measures

Primary Outcomes (1)

  • intervention applied to the experimental group

    At the end of 8 weeks of progressive relaxation exercises, improvement in premenstrual syndrome symptoms of the experimental group is expected.

    It includes an 8-week process.

Study Arms (2)

Experimental

EXPERIMENTAL

Progressive relaxation exercises will be performed for 25-30 minutes every day for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS.

Behavioral: Progressive Relaxation Exercises

Control

NO INTERVENTION

They will continue their routine coping habits for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS.

Interventions

Progressive muscle relaxation (PMR) is a relaxation technique that tenses and relaxes muscles in an unprompted, regular, and consecutive manner until the whole body is relaxed.

Experimental

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe research was conducted with women between the ages of 18-35.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18-35 years old, single marital status,
  • Willingness and volunteering to work,
  • Being able to read and write in Turkish and understand what he reads,
  • Applying to the obstetrics and gynecology outpatient clinic for routine control,
  • Getting a score of 110 and above in PMSS.

You may not qualify if:

  • The woman has an obstetric or medical health problem that prevents her from doing progressive relaxation exercises,
  • Having a chronic and gynecological health problem,
  • Regular exercise,
  • There is a change in menstrual characteristics in the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No Masking
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 23, 2022

Study Start

March 15, 2022

Primary Completion

July 30, 2022

Study Completion

December 30, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations