Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003543
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-08-16
Brief Title:
The Effect of Virtual Reality Application on Pain Fear and Anxiety in Patients Undergoing Colonoscopy
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Virtual Reality Application on Pain Fear and Anxiety in Patients Undergoing Colonoscopy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients 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
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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None