Before Colonoscopy Effect of Virtual Reality Application on Anxiety and Vital Signs

Colonoscopy Clinical Trial

Official title:

Examining the Effect of Virtual Reality Application on Patient's Anxiety and Vital Signs Before Colonoscopy: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407531
• Other study ID #: VRG208
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Akdeniz University
• Contact: Seda Cansu Yenigün, PhD
• Phone: 05077286208
• Email: seda.cansu.yenigun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned to examine the effect of virtual reality application on the patient's anxiety and vital signs before colonoscopy. The hypotheses of the research are as follows:

H1: Virtual reality application before colonoscopy has an effect on patients' anxiety and vital signs.

H0: Virtual reality application before colonoscopy has no effect on patients' anxiety and vital signs.

Before colonoscopy, patients in the study group will be asked to watch videos using virtual reality glasses.

Description:

After obtaining the ethics committee and institutional permission for the research, the researcher was taken to the hospital for the colonoscopy procedure.

He/she will introduce himself/herself to the patients and explain the purpose of the research. Patients who volunteered to participate in the study Informed consent will be obtained. Data regarding the socio-demographic characteristics of the patients included in the patient introduction form The patient will be interviewed face to face, and data regarding the patients' clinical characteristics will be recorded from the patient file. colonoscopy Data will begin to be collected from the first patient to undergo the procedure. Anxiety and life assessment with VAS 30 minutes before the procedure The findings will be considered. According to the randomization, the patient in the virtual reality glasses group was first asked by the researcher.

It will be explained to the patient that he will wear the glasses for 30 minutes and watch a video before the procedure. By researcher 30 When the minute is up, the patient will be informed and asked to remove the glasses. No intervention was made to the patient in the control group.

It will not be done. Anxiety and vital signs were measured with VAS 5-10 minutes before the procedure began in all patient groups.

will be looked into. After each patient use, the virtual reality glasses will be cleaned and dried with alcohol-based cleaning material.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Volunteering to participate in the research,

• Being literate,

• Be 18 years or older.

Exclusion Criteria:

• Performing colonoscopy at the same time as endoscopy,

• Using any analgesic or anxiolytic,

• Having a visual or hearing impairment,

• Performing an emergency colonoscopy.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Other:
• VR-G
Patients watched videos with virtual glasses before undergoing colonoscopy

Locations

Country	Name	City	State
Turkey	Finike State Hospital	Antalya	Finike

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety (Visual Analog Scale-Anxiety)	Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.	30 minutes before colonoscopy
Primary	Anxiety (Visual Analog Scale-Anxiety)	Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.	5-10 minutes before colonoscopy
Primary	Systolic blood pressure	In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.	30 minutes before colonoscopy
Primary	Systolic blood pressure	In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.	5-10 minutes before colonoscopy
Primary	Diastolic blood pressure	In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.	30 minutes before colonoscopy
Primary	Diastolic blood pressure	In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.	5-10 minutes before colonoscopy
Primary	Heart rate	In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.	5-10 minutes before colonoscopy
Primary	Heart rate	In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.	30 minutes before colonoscopy