Effect of Virtual Reality on Preoperative Anxiety

The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery

The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Other: VR application group

Detailed Description

The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yenisehir
    • Mersin, Yenisehir, Turkey, 33343
      • Mersin University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:The study included

• conscious,
• orientated and cooperated patients who could speak and understand Turkish,
• who had no psychiatric diseases,
• who were 18 years old and older,
• who were scheduled for elective colorectal surgery for the first time,
• who did not take any sedative drugs before surgery, and
• who gave written and oral permission to participate in the study

Exclusion Criteria:n The study excluded

• had language problems,
• underwent emergency surgery,
• were over 65 years of age and
• refused to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR application group; The experimental group received VR application in the preoperative period for 10 minutes.	Other: VR application group; During the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music.
No Intervention: Control group; The control group received the routine procedure in the unit clinic where the study was conducted. The routine procedure of the unit includes patients are taken to the operating room on a stretcher and wait on the stretcher in the surgery waiting room until the operation room is prepared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Anxiety Specific to Surgery Questionnaire score	The psychological response of patients to preoperative anxiety was evaluated with Anxiety Specific to Surgery Questionnaire. With a total of 10 items, responses are made on a five-point Likert scale format ranging from 1 (do not agree at all) to 5 (completely agree). Anxiety Specific to Surgery Questionnaire score is obtained by adding the answers to all items (minimum score=10; maximum score=50). The increase in the scale score indicates that the level of anxiety increases. The researchers administered Anxiety Specific to Surgery Questionnaire to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement.	10 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change systolic blood pressure	Determine patients' physiological responses (systolic blood pressure) of preoperative anxiety after virtual reality application The researchers measured systolic blood pressure to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their systolic blood pressure values were followed on the portable monitor (Vismo, Nihon Kohden, Germany).	10 minute
Change diastolic blood pressure	Determine patients' physiological responses (diastolic blood pressure) of preoperative anxiety after virtual reality application The researchers measured diastolic blood pressure to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their diastolic blood pressure values were followed on the portable monitor (Vismo, Nihon Kohden, Germany)	10 minute
Change heart rate	Determine patients' physiological responses (heart rate) of preoperative anxiety after virtual reality application The researchers measured heart rate to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their heart rate were followed on the portable monitor (Vismo, Nihon Kohden, Germany)	10 minute
Change respiratory rate	Determine patients' physiological responses (respiratory rate) of preoperative anxiety after virtual reality application The researchers measured respiratory rate to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their respiratory rate were followed on the portable monitor (Vismo, Nihon Kohden, Germany)	10 minute
Change peripheral oxygen saturation	Determine patients' physiological responses ( peripheral oxygen saturation) of preoperative anxiety after virtual reality application The researchers measured peripheral oxygen saturation to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their peripheral oxygen saturation were followed on the portable monitor (Vismo, Nihon Kohden, Germany)	10 minute

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Principal Investigator: Gulay Altun Ugras, PhD, Mersin University, Nursing Faculty

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: colorectal surgery; virtual reality; nurse
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Gulay Ugras

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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