Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy

Pain Clinical Trial

Official title:

The Effect of Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level and Patient Satisfaction in Patients to be Applied With Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05797142
• Other study ID #: 2020-11
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: March 2023
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate the effect of relaxation exercise with VR (Virtual Reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and satisfaction in patients undergoing endoscopy.

Description:

Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Being over 18 years old

• Ability to communicate adequately

• Absence of psychiatric problems

• Volunteering to participate in the research

Exclusion Criteria:

Those who have communication problems

• Those with psychiatric problems

• Being unconscious

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Other:
• Virtual reality glasses
Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30 minutes).

Locations

Country	Name	City	State
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul	Turkiye

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	Baseline (Before endoscopy)
Primary	Visual Analog Scale	The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	5 minute after endoscopy
Secondary	Anxiety Assessment Scale	Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Anxiety Assessment Scale, line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.	Baseline (Before endoscopy)
Secondary	Anxiety Assessment Scale	Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Anxiety Assessment Scale, line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.	5 minute after endoscopy
Secondary	Physiological Symptoms of Anxiety Follow-up Form	This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.	Baseline (Before endoscopy)
Secondary	Physiological Symptoms of Anxiety Follow-up Form	This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.	1 minute after endoscopy
Secondary	Virtual Reality Glasses Application Satisfaction Form	In this form, there are questions prepared in line with the relevant literature in order to determine the satisfaction with the video watched with virtual reality glasses.	5 minute after endoscopy