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The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery

Primary Purpose

Anxiety

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Watching video with virtual glasses
watching video without virtual glasses
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring anxiety, preoperative period, virtual reality

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being 18 years or older, To be able to communicate in Turkish, Volunteering to participate in the research To have abdominal surgery Not applying isolation to the patient It was determined that there is no obstacle to communication. Exclusion Criteria: Not volunteering to participate in the research To have a surgical intervention other than abdominal surgery Failure to communicate The patient is in isolation Having a vision problem Having a health problem that prevents using virtual glasses Premedication has been applied

Sites / Locations

  • Trakya University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Virtual Reality Glasses Group

Non-Virtual Reality Glasses Group

Control Group

Arm Description

The intervention group will watch a virtual reality video with mobile virtual glasses by the researcher (SŞ) and the stress level on the smart wristband will be recorded. In addition, necessary variables will be recorded with the data collection form.

The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded. In addition, necessary variables will be recorded with the data collection form.

Anxiety control will be done by the researcher (SU) for the control group.

Outcomes

Primary Outcome Measures

Preoperative Anxiety Level-1
stress level measured by smart bracelet VAS-A scale-before watching video
Preoperative Anxiety Level-2
stress level measured by smart bracelet and VAS-A scale-after watching video

Secondary Outcome Measures

Full Information

First Posted
January 30, 2023
Last Updated
February 7, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT05718661
Brief Title
The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Official Title
The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. In the pre-surgical period, the nurse's practices that will facilitate the patient's coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms. For these reasons, it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.
Detailed Description
Questions to be Answered in the Study The questions expected to be answered in the study to be conducted to evaluate the effect of acupressure application on the anxiety level in the preoperative period in patients who will undergo abdominal surgery; What is the frequency of anxiety before abdominal surgery? What is the effect of virtual reality on anxiety management before abdominal surgery? Variables of the Research Preoperative anxiety scale/level Data Collection Tools Patient Information Form, VAS-A and a smart wristband with stress level measurement feature will be used to collect data. Form-1.Patient Information Form: It is a form consisting of sociodemographic questions created by the researchers. Form-2. Visual Anxiety Scale (VAS-A): The Numerical Anxiety Severity Scale consists of a horizontal line that begins with the expression "0" or "no anxiety" and ends with the expression "100" or "severe anxiety". The patient is asked to choose the number that best describes the pain, between 0 and 100, by showing the scale. The result of the scale was evaluated over the arithmetic mean (Carr et al 2005; Kindler et al 2000). Smart Wristband: A smart wristband with photoplethysmography (PPG) feature that detects and reports stress-related changes will be used. After assessing whether the data fit the normal distribution with the Kolmogorov Smirnov test, if the data fit the normal distribution, parametric tests (Single Sample t-Test, One- and Multi-Way Analysis of Variance, Spearman's Correlation Analysis); if the data do not fit the normal distribution, non-parametric tests (Mann-Whitney U Test, Kruskall Wallis Test, Friedman Test, Pearson's Correlation Analysis) will be used. Mean, standard deviation and percentage distribution methods will be used in the descriptive analysis of the data. The power of the sample will be calculated with the post hoc analysis to be made. The universe of the research; Between 01.03.2023 and 01.12.2023, all patients who will undergo abdominal surgery in the Trakya University Health Research Center General Surgery Clinic will form. The sample of the research; The sample will consist of individuals who meet the selection criteria and volunteer to participate in the research. Sample of the Study: Mosso et al. (2009) in the study titled "Virtual reality on mobile phones to reduce anxiety in outpatient surgery" in which the anxiety levels of patients who used virtual reality in the preoperative period were evaluated using VAS-A. Accordingly, the effect size was calculated as d=0.920. In the calculation of the sample size, using the G-Power (G-Power 3.1.9.7, Kiel, Germany) program, effect size d=0.920, margin of error=0.05, power (1-β err probe)=0.95, 32 patients were included in each group. needed was determined. Using this number; For the initiative group; 32 patients For the control group; 32 patients For the placebo group; The total number of patients to be sampled was planned to be 96, 32 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, preoperative period, virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This research was designed using the experimental (intervention) research method. Under the same environment and conditions, to determine the effect on the same dependent variable, the intervention (experimental) group using virtual reality and the placebo group not using virtual reality (watching the same video with the naked eye), pre-test (measurement of the dependent variable before the intervention), post-test (dependent measurement of the variable after intervention). In addition, the group that was not interfered with will form the control group and a data collection form will be applied with an interval of 30 minutes.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Glasses Group
Arm Type
Experimental
Arm Description
The intervention group will watch a virtual reality video with mobile virtual glasses by the researcher (SŞ) and the stress level on the smart wristband will be recorded. In addition, necessary variables will be recorded with the data collection form.
Arm Title
Non-Virtual Reality Glasses Group
Arm Type
Placebo Comparator
Arm Description
The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded. In addition, necessary variables will be recorded with the data collection form.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Anxiety control will be done by the researcher (SU) for the control group.
Intervention Type
Behavioral
Intervention Name(s)
Watching video with virtual glasses
Intervention Description
Using Mobile Virtual Glasses; In the preoperative period, after the patient is taken to the surgical service, a virtual reality video will be watched with mobile virtual glasses at the specified time (before going to the operating room on the day of surgery). Measurements will be made before and after the application. Necessary hygiene will be provided before the use of glasses, and the researcher will ensure hand cleaning before entering the patient's room.
Intervention Type
Behavioral
Intervention Name(s)
watching video without virtual glasses
Intervention Description
The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded.
Primary Outcome Measure Information:
Title
Preoperative Anxiety Level-1
Description
stress level measured by smart bracelet VAS-A scale-before watching video
Time Frame
2 minute
Title
Preoperative Anxiety Level-2
Description
stress level measured by smart bracelet and VAS-A scale-after watching video
Time Frame
2 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being 18 years or older, To be able to communicate in Turkish, Volunteering to participate in the research To have abdominal surgery Not applying isolation to the patient It was determined that there is no obstacle to communication. Exclusion Criteria: Not volunteering to participate in the research To have a surgical intervention other than abdominal surgery Failure to communicate The patient is in isolation Having a vision problem Having a health problem that prevents using virtual glasses Premedication has been applied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dogan Albayrak, Dr
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trakya University Hospital
City
Edirne
ZIP/Postal Code
22000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It will be decided to share the data after the ethics committee decision for which the study permit is obtained.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
The primary author is reached via e-mail and if requested, data will be shared with the consent of all authors.
Citations:
PubMed Identifier
18550203
Citation
Herrera-Espineira C, Rodriguez del Aguila Mdel M, Rodriguez del Castillo M, Valdivia AF, Sanchez IR. Relationship between anxiety level of patients and their satisfaction with different aspects of healthcare. Health Policy. 2009 Jan;89(1):37-45. doi: 10.1016/j.healthpol.2008.04.012. Epub 2008 Jun 11.
Results Reference
background
PubMed Identifier
20124283
Citation
Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.
Results Reference
background
PubMed Identifier
16033593
Citation
Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.
Results Reference
background
PubMed Identifier
32498771
Citation
Hendricks TM, Gutierrez CN, Stulak JM, Dearani JA, Miller JD. The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Mayo Clin Proc. 2020 Jun;95(6):1148-1157. doi: 10.1016/j.mayocp.2020.02.032.
Results Reference
background
PubMed Identifier
19377147
Citation
Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
Results Reference
background
Links:
URL
https://www.youtube.com/watch?v=uEMmpJgaXvo&ab_channel=4KRelaxationChannel
Description
video that participants will watch with mobile virtual glasses - also video that participants will watch without virtual glasses

Learn more about this trial

The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery

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