Clinical trial NCT06003543: The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy
Official title: The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: Fear
Colonoscopy,
Pain
Anxiety
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or treating gastrointestinal system diseases by entering through the anus with a flexible, thin tube with a camera at the end, called a colonoscope. All parts of the large intestine with colonoscopy; ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum and anal canal by retroflexion can be evaluated. Colonoscopic interventions applied in gastroenterology cause pain, fear and anxiety in patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale -Pain
timeFrame: 1 hours later
measure: Visual Analog Scale - Fear
timeFrame: 1 hours later
measure: Visual Analog Scale -Anxiety
timeFrame: 1 hours later
measure: State-Trait Anxiety Inventory
timeFrame: 1 hours later
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat university
state: Center
Study officials:
affiliation: Firat University
name: Gülcan B.TURAN
role: PRINCIPAL_INVESTIGATOR
References: