The Effect of Virtual Reality Application on Pain, Anxiety, Vital Signs on Hernia Patients Operated With Spinal Anesthesia

NCT ID: NCT07065084

Last Updated: 2025-07-17

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

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2023-06-23

Brief Summary

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Abstract The aim of this study was to evaluate the effect of virtual reality application on pain, anxiety and vital signs during the procedure. This randomized controlled study included 110 hernia patients who underwent spinal anesthesia in the General Surgery Operating Room of a hospital in the western region of Turkey. Patients were randomly assigned to the experimental group or the control group. Patients in the experimental group (n=55) were shown virtual reality goggles and a music-enhanced video for 20 minutes during the surgical procedure. Patients in the control group (n=55) received standard nursing care. Patients in both groups were evaluated using VAS, State and Trait Anxiety Inventory, and Life Findings Monitoring Form.

Keywords: Virtual Reality simulation, Anxiety, Surgery, Pain, Nursing Care

Detailed Description

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Conditions

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Patient Centered Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention: one group was shown a video with virtual reality goggles during the surgical intervention.

control: this group underwent a routine surgical procedure throughout the surgical intervention. No intervention was performed.

The difference in pain, vital signs and anxiety between the two groups was analyzed.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

No additional masking was applied.

Study Groups

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Study (video wathced with VR glasses)

the patients in the intervention group were fitted with VR goggles by the researcher immediately after the spinal anesthesia was administered by the researcher during the operation in hernia patients who received spinal anesthesia for the study, when the patient was placed on the operating table and given the operating position, just before the surgical incision started. The procedures were performed without interfering with anesthesia and general operating room functioning. When the surgical incision was to be made, videos were started to be watched from the VR glasses simultaneously. During the 20 minute procedure, the licensed product "Relax with Nature" with music background with virtual reality glasses

Group Type EXPERIMENTAL

Virtual Reality glasses

Intervention Type PROCEDURE

In the study, the patients in the intervention group were fitted with VR goggles by the researcher immediately after the spinal anesthesia was administered by the researcher during the operation in hernia patients who received spinal anesthesia for the study, when the patient was placed on the operating table and given the operating position, just before the surgical incision started. The procedures were performed without interfering with anesthesia and general operating room functioning. When the surgical incision was to be made, videos were started to be watched from the VR glasses simultaneously. During the 20 minute procedure, the licensed product "Relax with Nature" with music background with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel screen resolution display unit, China) was watched with virtual reality application. Patients were shown videos of lakes, forests, waterfalls, rivers and beaches. In the studies, it was stated that these videos

Control (routine surgical procedure)

this group underwent a routine surgical procedure throughout the surgical intervention. No intervention was performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality glasses

In the study, the patients in the intervention group were fitted with VR goggles by the researcher immediately after the spinal anesthesia was administered by the researcher during the operation in hernia patients who received spinal anesthesia for the study, when the patient was placed on the operating table and given the operating position, just before the surgical incision started. The procedures were performed without interfering with anesthesia and general operating room functioning. When the surgical incision was to be made, videos were started to be watched from the VR glasses simultaneously. During the 20 minute procedure, the licensed product "Relax with Nature" with music background with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel screen resolution display unit, China) was watched with virtual reality application. Patients were shown videos of lakes, forests, waterfalls, rivers and beaches. In the studies, it was stated that these videos

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

diagnosed with hernia spinal anesthesia used

Exclusion Criteria

psychiatric/mental illness vision/hearing disability general anesthesia used
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celal Bayar University

OTHER

Sponsor Role lead

Responsible Party

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Dilek Çeçen Çamlı

Asist. Prof. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DILEK CECEN CAMLI

Role: PRINCIPAL_INVESTIGATOR

MCBÜ SAĞLIK BİLİMLERİ FAKÜLTESİ

Locations

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Manisa Celal Bayar University

Manisa, YUNUSEMRE, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Study Documents

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Document Type: Clinical Study Report

View Document

Other Identifiers

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24/11/2021/20.478.486/997

Identifier Type: -

Identifier Source: org_study_id

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