The Effect of Virtual Reality on Women Undergoing Endometrial Biopsy

NCT06961097 | Recruiting

• 1 other identifier: 2025/7/4
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety. Hypotheses H0: Virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy. H1: Virtual reality glasses have an effect on women's pain and anxiety during endometrial biopsy. The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an endometrial biopsy. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups. Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sounds music of the video will be played in the practice room with a bluetooth speaker. Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.

Conditions

Endometrial Biopsy

Outcome Measures

Primary Outcomes (2)

• Numerical Pain Scale

  It was developed to measure the pain level of patients. It is named differently at two ends on a vertical or horizontal line of ten centimeters (cm) in length (0=no pain, 10=highest level of pain). The numerical values specified by the patient indicate the pain intensity. The validity and reliability of the scale have been performed. It has been determined that it is a suitable method for assessing the pain intensity.

  immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure

• Change in anxiety

  STAI-S It is a self-assessment type scale consisting of short statements. While the State Anxiety Inventory (SAI) provides information only about what is felt at that moment, the Trait Anxiety Inventory (TAI) was developed to measure what has been felt in the last 7 days. The SAI-SAI is a Likert-type scale consisting of 20 items and graded from 1 to 4. It is reported that the reliability coefficients obtained as a result of studies conducted with normal and patient samples of the scale vary between .83 and .87

  immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. After being taken to the gynecological table for the endometraial biopsy procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sound music of the video will be played.

Other: Virtual Reality Group

control group

NO INTERVENTION

Interventions

Virtual Reality Group OTHER

control group

Also known as: control group

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*Being over 18 years old
• Speaking and understanding Turkish
• Being willing to participate in the research

You may not qualify if:

• Not volunteering to participate in research \* Not speaking or understanding Turkish

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Samsun University

Samsun, 55200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sümeyye BAL, Ph.D.

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

Sümeyye BAL, Ph.D

CONTACT

05434276696; sumeyyebal@gmail.com

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: Lecturer Ph. D.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

TU (1)