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

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.

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.

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