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Endometrial DiseasesNCT07694037

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

A study testing progressive muscle relaxation exercise in people with Endometrial Diseases, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometrial Diseases
What is being tested?
progressive muscle relaxation exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2025to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Esenyurt Necmi Kadıoğlu State Hospital

    Istanbul, Esenyurt, 3434

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
progressive muscle relaxation exercise
Keywords
progressive muscle relaxation, pain, anxiety, comfort, premenopausal
Medical subject headings
Uterine Diseases, Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • progressive muscle relaxation exerciseBehavioural

    progressive muscle relaxation exercise

Study groups in NCT07694037
Study groupRoleWhat they receive
progressive muscle relaxation exerciseExperimentalThe 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.
Receives: Behavioral: progressive muscle relaxation exercise
control groupActive comparatorThe 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.
Receives: Behavioral: progressive muscle relaxation exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 months

  2. 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).

    Measured: 2 months

  3. 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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start1 Sep 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
progressive muscle relaxation exercise and control
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694037
Sponsor's protocol ID
UskudarU-SBF-AK-01
Status last verified
Oct 2026
First submitted
8 May 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34151818

  • 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.

    PubMed 38636116

  • 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.

    PubMed 37061093

Questions about this trial

What is this clinical trial studying?

A study testing progressive muscle relaxation exercise in people with Endometrial Diseases, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07694037, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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