- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003543
The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy
The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy:
Study Overview
Detailed Description
High anxiety levels before the procedure can negatively affect the procedure by reducing patient compliance and may lead to the incompleteness of the procedure. Anxiety and fear experienced during colonoscopy cause more pain during the procedure.
In addition to pharmacological methods, there are non-pharmacological methods to provide patient comfort and manage the level of pain, fear and anxiety in interventional procedures such as colonoscopy. The methods used can be grouped under three main headings: physical, supportive and cognitive-behavioral. Cognitive-behavioral methods, which can be performed with practices such as relaxation and distraction, help control pain, fear and anxiety level.
The virtual reality application, developed thanks to the advancement of computer technology, is used as a cognitive-behavioral method to alleviate pain, fear and anxiety. With this method, the process of processing incoming pain signals slows down in patients who focus their attention on the environment they see, and fear, anxiety and pain are perceived less. It is important to relieve the patient's pain, fear and anxiety before colonoscopic interventions, to diagnose the patient correctly, to facilitate the health personnel who will perform the procedure, to facilitate the patient's compliance with the procedure, to prevent possible complications and to increase patient satisfaction. This study was planned to examine the effect of relaxation exercise, which will be performed with virtual reality application, which will distract their attention before and during the colonoscopy, on the experienced pain, fear and anxiety levels.
The research will be conducted as a randomized, experimental study with a pretest-posttest control group. The sample of the study will be composed of a total of 46 patients, 23 experimental and 23 control groups, who will be subjected to colonoscopy between August 2023- August 2024 in the Colonoscopy Unit of the Gastroenterology Polyclinic of Fırat University Hospital. Virtual reality application will be applied to the patient in the experimental group by the researcher 10 minutes before the procedure and 10-15 minutes during the procedure. The first measurement will be obtained by applying the Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety, State-Trait Anxiety Inventory (DSQ) and Patient Information Form to the patient in the experimental group before the procedure. The second measurement will be obtained by applying the Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale (DSQ) to the patient 10-15 minutes after the procedure. No intervention will be performed on the patients in the control group. 1 measurement will be obtained by applying the Patient Information Form, Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale before the procedure only. After the procedure, the second measurement will be obtained by re-applying the other forms except the Patient Information Form. The data will be analyzed using the SPSS 23 program. Shapiro Wilk test, t test, Mann-Whitney U test, Wilcoxon test and Chi-square analysis will be used in the analysis of the data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Center
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Elazığ, Center, Turkey, 25240
- Fırat University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to speak and understand Turkish
- Having cognitive competence to answer data collection tools
- Absence of communication problems (hearing, language, understanding, etc.)
- Not having a psychiatric diagnosis
- Absence of a history of convulsions
- Patients who underwent local application in colonoscopy
Exclusion Criteria:
- Those with communication problems
- Those with psychiatric problems
Study Plan
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 |
|---|---|
|
No Intervention: Control
no application will be made
|
|
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Experimental: Virtual Reality
virtual glasses will be applied
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Virtual Reality
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale -Pain
Time Frame: 1 hours later
|
Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest.
It has numbered shapes ranging from 1-10.
The line has 0 at the beginning and 10 at the end.
10 means unbearable pain, 0 means no pain.
The VAS scale is frequently used in the evaluation of pain severity.
While the patient marks the pain he/she has felt on this line, each point marked is measured in cm
|
1 hours later
|
|
Visual Analog Scale - Fear
Time Frame: 1 hours later
|
Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest.
It has numbered shapes ranging from 1-10.
The line has 0 at the beginning and 10 at the end.
10 means unbearable fear, 0 means no fear.
The VAS scale is frequently used in the evaluation of fear severity.
While the patient marks the fear he/she has felt on this line, each marked point is measured in cm
|
1 hours later
|
|
Visual Analog Scale -Anxiety
Time Frame: 1 hours later
|
Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest.
The line has 0 at the beginning and 10 at the end.
10 means unbearable pain, 0 means no pain.
VAS is frequently used in the evaluation of pain intensity.
While the patient marks the anxiety he/she has felt on this line, each marked point is measured in cm
|
1 hours later
|
|
State-Trait Anxiety Inventory
Time Frame: 1 hours later
|
Developed by Spielberg et al. (1970) to measure the state and trait anxiety levels of individuals, the scale, which consists of two parts and the English name is Speilberg's State-Trait Anxiety Inventory (STAI), is a self-tested reliability and validity study in Turkish by Öner and Le Compte (1977).
assessment scale (37-38) In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients.
Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the severity of the feelings, thoughts or behaviors expressed by the items. .
There are direct or reverse scored statements in the scale.
|
1 hours later
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülcan B.TURAN, Firat University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-19003918-730.08.03-347141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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