- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05154916
The Effect of Virtual Reality Based Relaxation Program on Patients to be Performed Bronchoscopy
July 2, 2023 updated by: gülcan bahcecioğlu, Ataturk University
The Effect of Virtual Reality-Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients to be Performed Bronchoscopy
With the virtual reality application in patients with bronchoscopy, it is aimed to reduce the fear, stress and tension arising from the possibility of the development of pain and complications in the patients.
The research will be carried out in the form of pretest-posttest application with 30 experimental and 30 control groups.
The researcher aims to minimize the fear and stress in the patient by applying the virtual reality application to the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during the procedure.
The researcher will download the licensed program called 'a walk on the beach' to the virtual reality glasses and the patient will watch this program with glasses.
The patient in the experimental group will have to fill in the Visual Analogue Scale, Anxiety Evaluation Form, Anxiety Symptoms Follow-up Form, and Patient Information Form before the procedure.
10-15 minutes after the procedure, the patient will be asked to fill the Visual Analogue Scale, Anxiety Evaluation Form, Anxiety Symptoms Follow-up Form and the Virtual Reality Glasses Application Satisfaction Form.
No procedure will be applied to the patients in the control group and they will be asked to fill in the Patient Information Form, Visual Analogue Scale Form, Anxiety Evaluation Scale Form, and Anxiety Symptoms Follow-up Form before the procedure.
After the procedure, he will be asked to fill in the other forms again, except the Patient Information Form.
Patients over the age of 18, who have no communication problems, no psychiatric problems, who volunteered to participate in the study, and who had local application in bronchoscopy will be included in the study.
Patients with psychiatric problems and communication problems will not be included in the study.
Before the procedure, the patient will be informed that his/her identity information will be kept confidential and that he/she can withdraw from the research at any time, and all his/her rights will be informed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy.
For this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment.
The virtual reality environment will be organized on the basis of relaxation exercise.
In this direction, first of all, an image will be created by taking 3D modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound.
Afterwards, the relaxation exercise created will be applied to the patients before and during the bronchoscopy application.
The aim of this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients to be Performed Bronchoscopy.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Center
-
Elazığ, Center, Turkey, 25240
- Fırat University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- be18 years and over
- Ability to communicate adequately
- Absence of psychiatric problems
- Those who are determined by the physician that they do not have a physical disability in exercising
- Volunteering to participate in the research
- Individuals who have the ability to use technological tools
- Patients who underwent local application in bronchoscopy
Exclusion Criteria:
- Those who have communication problems
- Those with psychiatric problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental:
Bronchoscopy of Virtual Reality Based Relaxation Program Will Be Applied
|
Virtual Reality Based Relaxation Program
|
|
No Intervention: No Intervention
Bronchoscopy of Virtual Reality Based Relaxation Program Will Not Be Applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale Evaluation
Time Frame: 60 minutes
|
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital.
Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0
points means no pain, 100 points means a lot of pain
|
60 minutes
|
|
Virtual Reality Glasses Application Satisfaction Form
Time Frame: 60 minutes
|
In this form, there are questions prepared in line with the relevant literature (Dutucu, 2019) in order to determine the satisfaction with the video watched with virtual reality glasses.The higher the score, the higher the satisfaction
|
60 minutes
|
|
Anxiety Assessment Scale
Time Frame: 60 minutes
|
Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line.
Line has 0 at the beginning and 10 at the end.
10 means very extreme anxiety and 0 means no anxiety.
|
60 minutes
|
|
Physiological Symptoms of Anxiety Follow-up Form
Time Frame: 60 minutes
|
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation value.These values will be checked again in 4 weeks.
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gülcan B Turan, Firat University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
November 18, 2021
First Submitted That Met QC Criteria
November 30, 2021
First Posted (Actual)
December 13, 2021
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
July 2, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- E-97132852-050.01.04-87889
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.