NCT05340101

Brief Summary

In this study, it was aimed to evaluate the effect of progressive muscle relaxation exercise on dysmenorrhea, menstrual symptoms and quality of life in university students with common primary dysmenorrhea. The research is a single center, parallel group block randomized controlled experimental study. This study will be conducted in the Department of Nursing, Faculty of Health Sciences, of a state university in Turkey. The universe of the research will be Gazi University Faculty of Health Sciences, third year and last year nursing students (N: 451). In order to determine the sample size in the research, power analysis was performed using the G Power 3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder Apay (2021), which were similar to our study, were taken as reference. According to the power analysis made by calculating the effect size; It was determined that the sample of the study should consist of a total of 42 people, 21 in each group, will be randomized. The data of the research; Personal information form will be collected using Visual Analogue Scale (VAS), SF-12 Quality of Life Scale Short Form, Menstrual Symptom Scale, Dysmenorrhea Monitoring Form. The implementation of the research is planned between April 15, 2022 and August 15, 2022. Third and fourth year nursing students will be included in the study. First of all, it will be evaluated according to the sampling inclusion criteria using the pre-evaluation form. Women who meet the inclusion criteria will be informed about the purpose and importance of the research, and women who agree to participate in the study will be determined. Informed consent form will be signed by the women who accepted to participate in the study, Visual Analogue Scale, Menstrual Symptom Scale and SF 12 Short Form will be applied. Randomization will be done after obtaining consent and filling out the forms.

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
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 30, 2022

Last Update Submit

April 15, 2022

Conditions

Keywords

DysmenorrheaQuality of LifeMenstrual Symptomsnursing students

Outcome Measures

Primary Outcomes (2)

  • change difference primary dysmenorrhea of the groups

    Visual Analog Scale

    8 weeks

  • change difference between the menstrual symptom scale scores of the groups

    menstrual symptom scale

    8 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

This group will practiced progressive muscle relaxation exercise

Behavioral: ROGRESSIVE MUSCLE RELAXATION EXERCISE

control group

NO INTERVENTION

This group will not practiced progressive muscle relaxation exercise

Interventions

In the application, "Relaxation Exercises CD Audio Recordings" prepared by the Turkish Psychological Association were used. In the the second part of 30 minutes were explained with the sound of the PKGE stream and verbal instructions. Audio recordings in the second part were used in this study. In line with the PCGE sound recordings, each muscle group starting from the hands to the feet, and then the facial and whole body muscles were stretched for about 10 seconds. The exercise was applied by taking deep breaths while tensing each muscle group, and releasing this breath slowly during relaxation. The relaxation lasted 10-20 seconds before the next muscle group was stretched. In this way, the muscles groups in the hands, arms, neck, shoulders, chest, abdomen, hips, feet and fingers, face and whole body were voluntarily stretched and relaxed, respectively, and the students were relaxed.

experimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having primary dysmenorrhea,
  • Being Nulligravida,
  • Having a history of regular menstrual cycles in the last six months (cycle duration 21-35 days),
  • Not using hormonal contraceptives,
  • A score of 5 or more on the visual analog scale (VAS).
  • Not to have metabolic disease, cancer, heart disease and diabetes, diagnosed psychiatric disease, and not using antidepressant medication that would prevent him from performing PCGE.
  • Not doing any other body-mind based practice
  • Using a smartphone
  • Not having any communication problems (mental, auditory, visual, etc.)

You may not qualify if:

  • Use of complementary therapies, anti-inflammatory therapy, antidepressants or anxiolytics during the study
  • Occurrence of menstrual cycle irregularity
  • Performing PKGE 3 times a week or less in a row

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sıdıka PELİT AKSU

Ankara, Turkey/Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sıdıka PELİT AKSU, PhD

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sıdıka PELİT AKSU, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research asistant (RN)

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 21, 2022

Study Start

April 15, 2022

Primary Completion

August 15, 2022

Study Completion

September 15, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations