NCT07065084

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 17, 2025

Status Verified

May 1, 2025

Enrollment Period

Same day

First QC Date

April 28, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

virtual realityağrıanxiety

Outcome Measures

Primary Outcomes (1)

  • pain level

    Patients' pain intensity was assessed intraoperatively and postoperatively using the Numerical Rating Scale (NRS). Scale scores range from 0-10. A high score indicates an increase in the patient's pain.

    preoperative and intraoperative: Two time

Secondary Outcomes (1)

  • Anxiety Level

    preoperative and intraoperative: two times

Study Arms (2)

Study (video wathced with VR glasses)

EXPERIMENTAL

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

Procedure: Virtual Reality glasses

Control (routine surgical procedure)

NO INTERVENTION

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

Interventions

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

Study (video wathced with VR glasses)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with hernia spinal anesthesia used

You may not qualify if:

  • psychiatric/mental illness vision/hearing disability general anesthesia used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, YUNUSEMRE, 45030, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • DILEK CECEN CAMLI

    MCBÜ SAĞLIK BİLİMLERİ FAKÜLTESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No additional masking was applied.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof. Dr

Study Record Dates

First Submitted

April 28, 2025

First Posted

July 15, 2025

Study Start

November 24, 2021

Primary Completion

November 24, 2021

Study Completion

June 23, 2023

Last Updated

July 17, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Reason for not sharing IPD: There is no plan to share IPD because the study was not designed for secondary data use.

Available IPD Datasets

Clinical Study Report (dilek.cecen@cbu.edu.tr)Access

Locations