Effect of Virtual Reality on Anxiety and Pain During Gynecological Examination

NCT ID: NCT07059780

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-03-30

Brief Summary

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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.

Detailed Description

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This study was designed to investigate the effect of virtual reality (VR) glasses on pain and anxiety levels experienced by women during gynecological examinations. It was conducted as a randomized controlled experimental study between February and November 2024 at Erciyes University Gevher Nesibe Hospital, Department of Obstetrics and Gynecology.

A total of 126 participants were randomly assigned to intervention and control groups (63 each). Inclusion criteria included women aged between 19 and 49 years, literate, and voluntarily agreeing to participate. Women with gynecological cancer, communication impairments, or visual/auditory disabilities were excluded.

The intervention group received standard gynecological examination procedures along with VR glasses showing immersive nature videos during the examination. The control group underwent the examination without VR intervention. Data collection tools included a Personal Information Form, Pain Beliefs Questionnaire, the Visual Analog Scale (VAS) for pain, and the State-Trait Anxiety Inventory-I (STAI-I) for anxiety. In addition, a Satisfaction Form was applied to the intervention group after the examination.

The aim of the study was to determine whether VR application can reduce perceived pain and anxiety during gynecological procedures. The findings of this study are expected to contribute to non-pharmacological nursing interventions in women's health practices.

Conditions

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Anxiety Pain Gynecological Examination Women's Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality Intervention Group

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.

Group Type EXPERIMENTAL

Virtual Reality Glasses

Intervention Type 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.

Routine Care Without VR Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality Glasses

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fazilet Nur Daşkın

OTHER

Sponsor Role lead

Responsible Party

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Fazilet Nur Daşkın

MSc Student in Nursing

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Evrim Bayraktar, PhD

Role: STUDY_CHAIR

Erciyes University Faculty of Health Sciences

Locations

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Erciyes University Gevher Nesibe Hospital

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/728

Identifier Type: OTHER

Identifier Source: secondary_id

ERU-SBE-FND-2025

Identifier Type: -

Identifier Source: org_study_id

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