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Clinical Trials/NCT06961097
NCT06961097CompletedNot Applicable

The Effect of Virtual Reality Glasess Application on Pain and Anxiety in Women Undergoing Endometrial Biopsy:A Randomized Controlled Research

Ondokuz Mayıs University1 site in 1 country68 target enrollmentStarted: May 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
68
Locations
1
Primary Endpoint
Numerical Pain Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

control group

No Intervention

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.

Intervention: Virtual Reality Group (Other)

Outcomes

Primary Outcomes

Numerical Pain Scale

Time Frame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure

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.

Change in anxiety

Time Frame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sümeyye BAL

Lecturer Ph. D.

Ondokuz Mayıs University

Study Sites (1)

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