Effect of Virtual Reality on Preoperative Anxiety

Preoperative Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547322
• Other study ID #: Gulay Ugras
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2020
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mersin University Hospital	Mersin	Yenisehir

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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