The Effect of Virtual Reality Application on Pain Severity, Anxiety Level and Patient Satisfaction

The Effect of Virtual Reality Application on Pain Severity, Anxiety Level and Patient Satisfaction in Patients Who Will Be Applied Coronary Angiography

In this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients Who Will Be Applied Angiography.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: Virtual reality glasses

Detailed Description

Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 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 (30-45 minutes).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Güneydoğu Anadolu Bölgesi
    • Istanbul, Güneydoğu Anadolu Bölgesi, Turkey, 21076
      • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being over 18 years old
• Ability to communicate adequately
• Absence of psychiatric problems
• Volunteering to participate in the research
• Experiencing coronary angiography for the first time

Exclusion Criteria:

• Those who have communication problems
• Those with psychiatric problems
• Emergency coronary angiography
• Having symptoms of myocardial infarction,
• Being unconscious,
• Having surgery in the last 6 weeks,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Routine maintenance will be applied
Experimental: Virtual reality glasses; Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 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 (30-45 minutes).	Other: Virtual reality glasses; Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 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 (30-45 minutes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before angiography (mean 6 months after study completion)
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.	After angiography (through study completion, an average of 6 month)
Anxiety Assessment Scale	Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.	Before angiography (mean 6 months after study completion)
Anxiety Assessment Scale	Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.	After angiography (through study completion, an average of 6 month)
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.	Before angiography (mean 6 months after study completion)
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.	After angiography (through study completion, an average of 6 month)
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.	Before angiography (mean 6 months after study completion)
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.	After angiography (through study completion, an average of 6 month)

Collaborators and Investigators

• Sponsor: Istanbul Sabahattin Zaim University

Publications and helpful links

General Publications

• 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. Epub 2022 Apr 7.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; virtual reality glasses; Angiography.
• Additional Relevant MeSH Terms: Mental Disorders; Neurologic Manifestations; Anxiety Disorders; Pain
• Other Study ID Numbers: 6811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No