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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04547322
Other study ID # Gulay Ugras
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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