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Clinical Trial NCT06961097 for Endometrial Biopsy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Effect of Virtual Reality on Women Undergoing Endometrial Biopsy 64 Virtual

Recruiting
Clinical Trial NCT06961097 is an interventional study for Endometrial Biopsy that is recruiting. It started on 1 May 2025 with plans to enroll 64 participants. Led by Ondokuz Mayıs University, it is expected to complete by 1 June 2026. The latest data from ClinicalTrials.gov was last updated on 20 July 2025.
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 i...

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Official Title

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

Conditions
Endometrial Biopsy
Other Study IDs
  • 2025/7/4
NCT ID Number
NCT06961097
Start Date (Actual)
2025-05-01
Last Update Posted
2025-07-20
Completion Date (Estimated)
2026-06-01
Enrollment (Estimated)
64
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVirtual 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. 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, th...Show More
Virtual Reality Group
control group
No Interventioncontrol group
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes

  • *Being over 18 years old

    • Speaking and understanding Turkish
    • Being willing to participate in the research

  • Not volunteering to participate in research * Not speaking or understanding Turkish
Ondokuz Mayıs University logoOndokuz Mayıs University
Study Responsible Party
Sümeyye BAL, Principal Investigator, Lecturer Ph. D., Ondokuz Mayıs University
Study Central Contact
Contact: Sümeyye BAL, Ph.D, 05434276696, [email protected]
1 Study Locations in 1 Countries
Samsun University, Samsun, 55200, Turkey (Türkiye)
Sümeyye BAL, Contact, 05434276696, [email protected]
Recruiting