The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients: A Double-Blinded Randomised Controlled Trial
Phase: NA
Conditions: Anxiety
Sponsor: Trakya University

 
Official Title of the Study: 
The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in 
Abdominal Surgery Patients: A Double-Blinded Randomized Controlled Trial 
Date 
30.05.2022 
Protocol Number / Registration ID: 
ClinicalTrials.gov Identifier: NCT05718661 
Document Type: 
Study Protocol and Statistical Analysis Plan 
Principal Investigator: 
Dr. Sevim Akbal, RN, Trakya University Faculty of Health Sciences, Department of Nursing 
Sponsor: 
Trakya University 
Study Site: 
General Surgery Service, Trakya University Hospital, Edirne, Türkiye 
Confidentiality Statement: 
This document contains confidential information intended for use by the research team and 
authorized personnel only. No part of this document may be disclosed to any third party without 
prior written consent of the principal investigator or study sponsor. 
 
 
 
 
 
 
 

Study Protocol and Statistical Analysis Plan  
1.Study Title  
The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal  
Surgery Patients: A Double-Blinded Randomized Controlled Trial  
2. Study Protocol  
2.1 Aim  
This study aimed to evaluate the effectiveness of virtual reality (VR) distraction in alleviating 
preoperative anxiety among patients scheduled for abdominal surgery 
2.2 Design  
This is a double-blinded (blinded to data collection and data analysis) randomized controlled trial 
conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. 
The study protocol is registered at ClinicalTrials.gov (ID: NCT05718661). 
2.3 Study Setting and Period  
The study was conducted between December 1, 2022, and December 20, 2024, at the General Surgery 
Service of a university hospital in the Trakya region, Edirne, Türkiye. The hospital serves as a referral 
center and contributes to medical and health sciences education. 
2.4 Participants  
Inclusion Criteria: 
• 
Adults aged ≥18 years  
• 
Undergoing elective abdominal surgery (e.g., appendectomy, hernia, gallbladder/pancreas surgery)  
• 
Awaiting transfer to the operating room in the morning  
• 
Able to communicate and provide informed consent  
Exclusion Criteria: 
• 
Abdominal cancer surgery 
• 
Emergency or unplanned surgery 
• 
Isolation status 
• 
Visual/auditory impairments 
• 
Neurological disorders (e.g., vertigo)  
 
 
2.5.Sample Size 
The sample size was calculated based on the study by Mosso et al. (2009) using G*Power 3.1.9.7 
software. With an effect size of d=0.920, alpha=0.05, and power=0.95, a total of 96 patients were 
required (32 in each group). 
 
2.6 Randomization  
 

Patients were randomized using the Research Randomizer tool (https://www.randomizer.org/) into 
three groups: VR, placebo-video, and control. 
 
3.Interventions and Data Collection 
 
3.1 Tools  
 
Patient Information Form: Sociodemographic and clinical data. 
Visual Analog Scale-Anxiety (VAS-A): Scores from 0 (no anxiety) to 10 (maximum anxiety). 
Smart Bracelet (Xiaomi Mi Band 5): Measures heart rate variability-based stress (1100 scale). 
3.2.Procedures 
Evaluation 1 (T1): 
-Conducted in the patient’s room in the morning. 
-Informed consent obtained; forms and baseline anxiety/stress measurements completed. 
Evaluation 2 (T2): 
-Conducted 10–15 minutes after intervention or rest period  
 
Virtual Reality Group: 
-Watched a 2-hour 4K virtual forest video 
(https://www.youtube.com/watch?v=uEMmpJgaXvo). 
-Used Zore G04E VR Shinecon headset with headphones and disposable eye covers. 
-The researcher observed for any adverse effects. 
 
 
Placebo-Video Group: 
 
Watched the same video on a smartphone using disposable headphones  
 
Control Group 
No intervention; second evaluation conducted after ~15 minutes of rest. 
 
4.Ethical Considerations  
Approval was obtained from the Trakya University Ethics Committee (TÜTF-GOBAEK 2022/240) 
and the hospital administration (E-51088030-100-317619). All participants provided verbal and 
written informed consent. The study adhered to the Helsinki Declaration and CONSORT guidelines 
5.Statistical Analysis Plan 
5.1.Software 
Data analysis was performed using IBM SPSS Statistics for Windows, Version 28.0 
5.2.Descriptive Statistics 
-Continuous variables (e.g., age, anxiety, stress): Mean, SD, median, min, max 
-Categorical variables (e.g., gender, education, chronic diseases): Frequency and percentage 

5.3.Normality Testing 
Shapiro-Wilk test for all continuous variables 
5.4.Inferential Statistics: 
-Between-Group Comparisons:  
Kruskal-Wallis H Test for comparing continuous variables across the three groups  
Mann-Whitney U Test with Bonferroni correction for post-hoc pairwise comparisons  
-Within-Group Comparisons (T1 vs. T2): 
Wilcoxon Signed Ranks Test  
 
-Categorical Variables: 
Pearson Chi-Square Test  
5.5.Statistical Significance 
Significance level set at p < 0.05 
Confidence interval: 95%