Back to resultsEffect of Virtual Reality on Preoperative Anxiety
Primary Purpose
Preoperative Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
VR application group
Sponsored by
About this trial
This is an interventional supportive care trial for Preoperative Anxiety focused on measuring colorectal surgery, virtual reality, nurse
Eligibility Criteria
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.
Sites / Locations
- Mersin University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VR application group
Control group
Arm Description
The experimental group received VR application in the preoperative period for 10 minutes.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04547322
Brief Title
Effect of Virtual Reality on Preoperative Anxiety
Official Title
The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin 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
The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety
Keywords
colorectal surgery, virtual reality, nurse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, parallel, two arm, randomized controlled clinical trial
Masking
Participant
Masking Description
The researchers involved in the data analysis and statistics stages were blinded to the group assignment, too. However, those involved in the running of the study were not blinded. Also, the person who performed the measurements was not blinded due to the nature of VR application.
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR application group
Arm Type
Experimental
Arm Description
The experimental group received VR application in the preoperative period for 10 minutes.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
VR application group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Anxiety Specific to Surgery Questionnaire score
Description
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.
Time Frame
10 minute
Secondary Outcome Measure Information:
Title
Change systolic blood pressure
Description
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).
Time Frame
10 minute
Title
Change diastolic blood pressure
Description
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)
Time Frame
10 minute
Title
Change heart rate
Description
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)
Time Frame
10 minute
Title
Change respiratory rate
Description
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)
Time Frame
10 minute
Title
Change peripheral oxygen saturation
Description
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)
Time Frame
10 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulay Altun Ugras, PhD
Organizational Affiliation
Mersin University, Nursing Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mersin University Hospital
City
Mersin
State/Province
Yenisehir
ZIP/Postal Code
33343
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Virtual Reality on Preoperative Anxiety
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