The Effect of Progressive Muscle Relaxation Exercise Applied Before Endometrial Biopsy on Pain, Anxiety Level and Patient Comfort in Premenopausal Women

July 6, 2026 updated by: Ayşegül KARAKOÇ, Uskudar University
This study was designed to determine the effect of progressive muscle relaxation exercises performed before endometrial biopsy on pain, anxiety levels, and patient comfort in premenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to implement progressive muscle relaxation exercises to control and minimize feelings such as pain, anxiety, and discomfort experienced by women prior to undergoing endometrial biopsy procedures for diagnostic and screening purposes during the premenopausal period. The study aims to examine whether the application of progressive muscle relaxation exercises results in a reduction in pre-procedure anxiety and an increase in comfort among women.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Esenyurt
      • Istanbul, Esenyurt, Turkey (Türkiye), 3434
        • Istanbul Esenyurt Necmi Kadıoğlu State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Endometrial biopsy request must be performed using an endometrial biopsy cannula (Pipelle).
  • Aged 40 years or older with irregular cycles.
  • At least a primary school graduate.
  • No impediment to performing progressive relaxation exercises.
  • The patient's consent to participate in the study.

Exclusion Criteria:

  • Presence of any physical or mental disability.
  • The patient's refusal to participate in the study.
  • Presence of any neurological or psychiatric disorder/use of medication
  • Having entered menopause.
  • Having a disease that could prevent the exercises from being performed (musculoskeletal problems, asthma, etc.).
  • The patient having previously undergone an abortion, endometrial biopsy, or endocervical biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: progressive muscle relaxation exercise
The group will receive pre-procedure training on progressive muscle relaxation exercises prior to the study. The researcher will explain how to perform the exercise and its importance for patients for approximately 5 minutes. Patients will then be instructed to perform progressive muscle relaxation exercises in a quiet room that will not distract them, using a tablet and headphones to listen to audio instructions. The patient will be taken to a screened-off area for dressing and undressing. The examination table and surgical instruments required for the patient's procedure will be prepared in a sterile manner. When the patient is ready, she will be taken to the gynecological table and the doctor will perform an endometrial biopsy.
Behavioral: progressive muscle relaxation exercise
progressive muscle relaxation exercise
Active Comparator: control group
The patient will be taken to a private changing room. When the patient is ready, she will be taken to the gynecological table and the doctor will perform an endometrial biopsy. Patients in good general health will be taken to the changing room to get dressed and will be informed about the procedure before being directed to the doctor's office for a prescription.
Behavioral: progressive muscle relaxation exercise
progressive muscle relaxation exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 2 months
Pain intensity was assessed using the Visual Analog Scale (VAS), a simple, reliable, and widely used unidimensional measure of subjective pain intensity (Hawker et al., 2011). The scale consists of a 10-cm horizontal or vertical line anchored by two descriptors representing the extremes of pain (0 = "no pain" and 10 = "worst imaginable pain"). Participants were asked to mark on the line the point that best represented their pain intensity. The score was determined by measuring the distance (in millimeters) from the "no pain" anchor to the participant's mark. It has been shown to correlate well with other clinical pain assessment tools and is frequently used in both research and clinical settings for its ease of use and sensitivity(Jensen et al., 1986).
2 months
State Anxiety Inventory (STAI Form I)
Time Frame: 2 months
State anxiety was assessed using the State-Trait Anxiety Inventory (STAI Form I), originally developed by Spielberger and colleagues to measure situational anxiety levels. The scale consists of 20 items evaluating how individuals feel "at the moment," rated on a 4-point Likert scale (1 = not at all to 4 = very much so). The Turkish validity and reliability study was conducted by Öner and Le Compte. The scale includes both direct and reverse-scored items (10 reverse items: 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). Total scores range from 20 to 80, with higher scores indicating greater anxiety levels. In the present study, the internal consistency of the STAI was high (Cronbach's α = 0.888).
2 months
General Comfort Questionaire (GCQ)
Time Frame: 2 months
Comfort was assessed using the General Comfort Questionnaire (GCQ), developed by Kolcaba based on the taxonomic structure of comfort theory, which includes three levels and four dimensions. The 48-item instrument is rated on a 4-point Likert scale and includes both positively and negatively worded items; negative items are reverse scored. Total scores range from 48 to 192, with higher scores indicating greater comfort. The final score is calculated by dividing the total score by the number of items, yielding a mean score between 1 and 4. The Turkish validity and reliability study was conducted by Karabacak and Kuğuoğlu, reporting a Cronbach's α of 0.85. In the present study, the internal consistency of the GCQ was excellent (Cronbach's α = 0.926). Subscale reliability coefficients were 0.915 for Relief, 0.908 for Ease, and 0.899 for Transcendence, indicating high reliability.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

October 25, 2025

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UskudarU-SBF-AK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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