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

The Effect of Virtual Reality Application on Pain, Anxiety and Vital Signs During the Procedure in Hernia Patients Operated With Spinal Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Patient Centered Care
• Intervention / Treatment: Procedure: Virtual Reality glasses

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yunusemre
    • Manisa, Yunusemre, Turkey, 45030
      • Manisa Celal Bayar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

diagnosed with hernia spinal anesthesia used

Exclusion Criteria:

psychiatric/mental illness vision/hearing disability general anesthesia used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
No Intervention: Control (routine surgical procedure); this group underwent a routine surgical procedure throughout the surgical intervention. No intervention was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Level	Anxiety scores of the patients before and after surgery were determined using the 'State-Trait Anxiety Inventory' prepared by Spielberger et al. The total score of the scale ranges between 20-80. A total score above 60 indicates severe anxiety. a high score on the scale in the study indicates that the patient's anxiety during and after the procedure is elevated.	preoperative and intraoperative: two times

Collaborators and Investigators

• Sponsor: Celal Bayar University
• Investigators: Principal Investigator: DILEK CECEN CAMLI, MCBÜ SAĞLIK BİLİMLERİ FAKÜLTESİ

Publications and helpful links

Helpful Links

• Like population
• like methods

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: July 14, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; virtual reality; ağrı
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 24/11/2021/20.478.486/997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Reason for not sharing IPD: There is no plan to share IPD because the study was not designed for secondary data use.

Study Data/Documents

1. Clinical Study Report
   Information identifier: dilek.cecen@cbu.edu.tr

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No