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

NCT07694037 | Completed

• 1 other identifier: UskudarU-SBF-AK-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Diseases

Keywords

progressive muscle relaxation; pain; anxiety; comfort; premenopausal

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS)

  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)

  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)

  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

Study Arms (2)

progressive muscle relaxation exercise

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

progressive muscle relaxation exercise BEHAVIORAL

progressive muscle relaxation exercise

control group; progressive muscle relaxation exercise

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Istanbul Esenyurt Necmi Kadıoğlu State Hospital

Istanbul, Esenyurt, 3434, Turkey (Türkiye)

Location

Related Publications (3)

• Yoo SA, Kim CY, Kim HD, Kim SW. Effects of progressive muscle relaxation therapy with home exercise on pain, fatigue, and stress in subjects with fibromyalgia syndrome: A pilot randomized controlled trial. J Back Musculoskelet Rehabil. 2022;35(2):289-299. doi: 10.3233/BMR-191703.

  PMID: 34151818 BACKGROUND

• Turan GB, Ozer Z, Sarikose A. The effects of progressive muscle relaxation exercise applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality: A randomized controlled trial. Eur J Oncol Nurs. 2024 Jun;70:102580. doi: 10.1016/j.ejon.2024.102580. Epub 2024 Apr 1.

  PMID: 38636116 BACKGROUND

• Vitale SG, Buzzaccarini G, Riemma G, Pacheco LA, Di Spiezio Sardo A, Carugno J, Chiantera V, Torok P, Noventa M, Haimovich S, De Franciscis P, Perez-Medina T, Angioni S, Lagana AS. Endometrial biopsy: Indications, techniques and recommendations. An evidence-based guideline for clinical practice. J Gynecol Obstet Hum Reprod. 2023 Jun;52(6):102588. doi: 10.1016/j.jogoh.2023.102588. Epub 2023 Apr 13.

  PMID: 37061093 BACKGROUND

Related Links

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MeSH Terms

Conditions

Uterine Diseases; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

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: Principal Investigator

Model Details: progressive muscle relaxation exercise and control

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: July 9, 2026
• Study Start: April 30, 2025
• Primary Completion: June 1, 2025
• Study Completion: October 25, 2025
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)