The Effect of Virtual Reality Application on Pain, Anxiety, Vital Signs on Hernia Patients Operated With Spinal Anesthesia
1 other identifier
interventional
102
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2023
CompletedFirst Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
July 15, 2025
CompletedJuly 17, 2025
May 1, 2025
Same day
April 28, 2025
July 14, 2025
Conditions
Keywords
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)
EXPERIMENTALthe 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
Control (routine surgical procedure)
NO INTERVENTIONthis 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
Eligibility Criteria
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)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DILEK CECEN CAMLI
MCBÜ SAĞLIK BİLİMLERİ FAKÜLTESİ
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
- 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.