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

NCT05797142 | Completed

• 1 other identifier: 2020-11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Pain

Keywords

virtual reality glasses; Pain; Anxiety; Endoscopy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Anxiety Assessment Scale

  Baseline (Before endoscopy)

• Anxiety Assessment Scale

  5 minute after endoscopy

• Physiological Symptoms of Anxiety Follow-up Form

  Baseline (Before endoscopy)

• Physiological Symptoms of Anxiety Follow-up Form

  1 minute after endoscopy

• Virtual Reality Glasses Application Satisfaction Form

  5 minute after endoscopy

Study Arms (2)

: Virtual reality glasses

EXPERIMENTAL

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).

Other: Virtual reality glasses

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Virtual reality glasses OTHER

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).

: Virtual reality glasses

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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

You may not qualify if:

• Those who have communication problems
• Those with psychiatric problems
• Being unconscious

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Turkiye, 340340, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: March 10, 2023
• First Posted: April 4, 2023
• Study Start: May 5, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)