Effect of Virtual Reality on Anxiety and Pain During Gynecological Examination

NCT07059780 | Completed

• 2 other identifiers: ERU-SBE-FND-20252023/728
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to examine the effects of using virtual reality (VR) glasses during gynecological examinations on women's pain and anxiety levels. A total of 126 women were randomly assigned to either an intervention group, who used VR glasses during the examination, or a control group, who received standard care. Visual and auditory stimuli from nature-themed videos were shown to the intervention group using VR glasses during the procedure. Participants' pain was assessed using the Visual Analog Scale (VAS), and anxiety was measured using the State-Trait Anxiety Inventory (STAI-I). The study was conducted between February and November 2024 at the Department of Obstetrics and Gynecology, Erciyes University Hospital.

Conditions

Anxiety; Pain; Gynecological Examination; Women's Health

Keywords

anxiety; pain; virtual reality; Women's Health; gynecological examination

Outcome Measures

Primary Outcomes (2)

• Change in State Anxiety Score (STAI-I)

  The State Anxiety Inventory (STAI-I) consists of 20 self-report items that measure how the individual feels at a specific moment. Each item is rated on a 4-point Likert scale: 1 (Not at all) to 4 (Very much so). The scale includes both direct and reverse-scored items. Reverse-scored items include items 1, 2, 5, 8, 10, 11, 16, 19, and 20. The total score is calculated by subtracting the sum of reverse-scored items from the sum of direct items and then adding 50. Total scores range from 20 to 80, with higher scores indicating greater anxiety. The questionnaire will be administered immediately before and 15 minutes after the gynecological examination. The change in scores will be analyzed to evaluate the intervention's effectiveness.

  Baseline (immediately before the examination) and Post-procedure (within 15 minutes after the examination)

• Visual Analog Scale for Pain (VAS)

  The Visual Analog Scale for Pain (VAS) is a widely used unidimensional tool designed to assess subjective pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" on the left end and "worst imaginable pain" on the right. Participants will be asked to place a mark along the line that best reflects the intensity of their current pain. The distance (in centimeters) from the left end to the mark will be measured, yielding a score between 0 and 10, with higher scores indicating greater pain intensity. The VAS will be administered once, within 10 minutes following the gynecological examination.

  Post-procedure (within 10 minutes after the gynecological examination)

Secondary Outcomes (1)

• Pain Beliefs Questionnaire - PBQ)

  Baseline (within 30 minutes before the gynecological examination)

Study Arms (2)

Virtual Reality Intervention Group

EXPERIMENTAL

Participants in this group underwent a routine gynecological examination while wearing virtual reality glasses that displayed immersive nature-themed videos with visual and auditory stimuli to reduce anxiety and pain.

Device: Virtual Reality Glasses

Routine Care Without VR Group

NO INTERVENTION

Participants in this group received standard gynecological examination without any virtual reality intervention. No visual or auditory stimulus was provided during the procedure.

Interventions

Virtual Reality Glasses DEVICE

Participants in the intervention group wore virtual reality (VR) glasses during the gynecological examination. The VR content included immersive nature-themed scenes accompanied by calming background music. The intervention aimed to provide a multisensory distraction to reduce perceived anxiety and pain levels during the procedure.

Virtual Reality Intervention Group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 19 and 49 years
• Literate and able to complete the questionnaire
• Agree to participate voluntarily
• Undergoing gynecological examination

You may not qualify if:

• Having a diagnosed gynecological cancer
• Hearing or visual impairments
• Cognitive or communication difficulties
• History of psychiatric illness
• Refusal to wear VR glasses

Sponsors & Collaborators

• Fazilet Nur Daşkın: lead

Study Sites (1)

Erciyes University Gevher Nesibe Hospital

Kayseri, Melikgazi, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evrim Bayraktar, PhD

  Erciyes University Faculty of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc Student in Nursing

Model Details: Participants were randomly assigned to two groups: the intervention group received virtual reality during the procedure, and the control group received standard care.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: February 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)