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

NCT05459246 | Completed

• 1 other identifier: 6811
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Pain

Keywords

virtual reality glasses; Pain; Anxiety; Angiography.

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Virtual reality glasses

EXPERIMENTAL

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

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Virtual reality glasses OTHER

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).

Virtual reality glasses

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Güneydoğu Anadolu Bölgesi, 21076, Turkey (Türkiye)

Location

Related 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. Epub 2022 Apr 7.

  PMID: 35397973 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zülfünaz Özer, PhD

  Istanbul Sabahattin Zaim University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Virtual reality glasses and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is an experimental study with pre-test and post-test control groups

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 14, 2022
• Study Start: July 4, 2022
• Primary Completion: September 29, 2022
• Study Completion: November 29, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)