The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level

Colonoscopy Clinical Trial

Official title: The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level

Status Not yet recruiting

Clinical Trial Summary

The study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses used during a colonoscopy on vital signs, pain, and anxiety level. After the approval of the ethics committee and institutional permission, 60 patients who applied to the endoscopy unit for colonoscopy procedure between 1 October 2020 and 1 October 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0,665 (effect size), α = 0.05 (margin of error), 1-β = 0.80 (Power) and by using the G-Power package program with the specified criteria. It was decided to recruit 58 people (29 people per group). The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Before the colonoscopy, the patient will be visited and information will be given about the purpose, content, and intervention to be applied. After obtaining verbal and written consent from the patients who accepted to participate in the study, the "Individual Characteristics Form" will be filled. Then, before the colonoscopy procedure, the anxiety states of the patients in the experimental and control groups will be asked with the "State and Trait Anxiety Inventory", their pain status with the Analog Scale (VAS), and their first life findings will be measured and the first measurement values will be recorded in the "Vital Signs Follow-up Form".

The patients in the experimental group will be informed about the virtual glasses before the colonoscopy procedure and the virtual reality glasses will be placed on the patient's head during the procedure. Then, during the colonoscopy procedure, the duration of the colonoscopy will vary between 3-10 minutes, and during the colonoscopy period, videos with music background, parks, nature and seaside walks, underwater, etc., will be watched by the patient and the "Vital Signs Tracking Form" The second measurement values will be saved by making measurement to.

Immediately after the colonoscopy procedure is finished, "Visual Analogue Scale (VAS)", "Life Findings Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. The standard application will be applied to the patients in the control group during the colonoscopy procedure and the second measurement values will be recorded by measuring the "Vital Signs Follow-up Form".Immediately after the colonoscopy procedure is completed, the third measurement value will be recorded by measuring the "Visual Analogue Scale (VAS)" and "Vital Signs Follow-up Form". "State Anxiety Inventory" will be read and the answers recorded.

Clinical Trial Description

The universe of the research; patients who are between October 1, 2020, and October 1, 2021, in the endoscopy unit for colonoscopy procedure where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's endoscopy unit between 1 October 2020 - 1 October 2021. The independent variable of the study is virtual reality glasses. The dependent variables of the study are anxiety states, pain intensity, and vital signs score average. In the research, "Individual Characteristics Form", "State and Trait Anxiety Inventory", the Analog Scale (VAS), and "Vital Signs Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Colonoscopy

• NCT number: NCT04710121
• Study type: Interventional
• Source: Istanbul University-Cerrahpasa
• Contact: Esra KILINÇ AKMAN, MSC
• Phone: +905548039273
• Email: esra.kilincakman@ogr.iu.edu.tr
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 3, 2021
• Completion date: December 20, 2021