Viewing Study NCT06333418



Ignite Creation Date: 2024-05-06 @ 8:19 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06333418
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-27
First Post: 2024-03-13

Brief Title: Effects of VR and Glass WF Colonoscopy
Sponsor: Suleyman Demirel University
Organization: Suleyman Demirel University

Study Overview

Official Title: The Effect of Virtual Rain Forest and Glass Waterfall on Satisfaction Comfort Anxiety and Vital Signs Undergoing Colonoscopy
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
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: VRWN_colon
Brief Summary: Background Today colonoscopy is widely used in many diseases especially in the screening and diagnosis of colorectal cancers Colonoscopy is considered a procedure that disturbs the patients comfort because it is a very invasive and painful procedure Along with physical discomfort during the procedure it triggers emotional disturbances such as fear and anxiety in the patient

Purpose To examine the effect of virtual rain forest and glass waterfall on satisfaction comfort anxiety and vital signs before colonoscopy Method The population of the study consists of all patients who applied to Mardin Education and Research Hospital Department of General Surgery Endoscopy Unit and were scheduled for colonoscopy The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample In calculating the sample of the study power analysis was performed and it was found the effect size of 040 95 power and 001 margin of error for this study that a total of 135 individuals for the three groups and at 60 individuals for each group GPower version 3010 was used for statistical power analysis The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program Before the arthroscopy procedure the patients included in the study will be randomly divided into three groups 45 rain forest video VR group 45 glass waterfall group and 45 control group All participants in the study will first fill out a patient identification form containing patient demographic information
Detailed Description: Background Today colonoscopy is widely used in many diseases especially in the screening and diagnosis of colorectal cancers Colonoscopy is considered a procedure that disturbs the patients comfort because it is a very invasive and painful procedure Along with physical discomfort during the procedure it triggers emotional disturbances such as fear and anxiety in the patient

Purpose To examine the effect of virtual rain forest and glass waterfall on satisfaction comfort anxiety and vital signs before colonoscopy Method The population of the study consists of all patients who will apply to Mardin Education and Research Hospital Department of General Surgery Endoscopy Unit and will be scheduled for colonoscopy The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample In calculating the sample of the study power analysis will be performed and it will be found the effect size of 040 95 power and 001 margin of error for this study that a total of 135 individuals for the three groups and at 60 individuals for each group GPower version 3010 was used for statistical power analysis The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program Before the arthroscopy procedure the patients included in the study will be randomly divided into three groups 45 rain forest video VR group 45 glass waterfall group and 45 control group All participants in the study will first fill out a patient identification form containing patient demographic information Before the colonoscopy procedure 360-degree VR rain forest video scenes will be watched 30 minutes using VR head device in virtual glasses group Glass Water group patients will watch and listen 30 minutes a portative glass waterfall

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