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

Sponsor
Istanbul Sabahattin Zaim University (Other)
Overall Status
Completed
CT.gov ID
NCT05797142
Collaborator
(none)
100
1
2
2.1
47.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality glasses
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is an experimental study with pre-test and post-test control groupsThis study is an experimental study with pre-test and post-test control groups
Masking:
Single (Participant)
Masking Description:
Virtual reality glasses and control group
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
May 5, 2021
Actual Primary Completion Date :
Jul 8, 2021
Actual Study Completion Date :
Jul 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: : 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).

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).

No Intervention: Control group

Routine maintenance will be applied

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale [Baseline (Before endoscopy)]

    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.

  2. Visual Analog Scale [5 minute after endoscopy]

    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.

Secondary Outcome Measures

  1. Anxiety Assessment Scale [Baseline (Before endoscopy)]

    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.

  2. Anxiety Assessment Scale [5 minute after endoscopy]

    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.

  3. Physiological Symptoms of Anxiety Follow-up Form [Baseline (Before endoscopy)]

    This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.

  4. Physiological Symptoms of Anxiety Follow-up Form [1 minute after endoscopy]

    This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.

  5. Virtual Reality Glasses Application Satisfaction Form [5 minute after endoscopy]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Sabahattin Zaim University, Faculty of Health Sciences Istanbul Turkiye Turkey 340340

Sponsors and Collaborators

  • Istanbul Sabahattin Zaim University

Investigators

  • Principal Investigator: Zülfünaz Özer, PhD, Istanbul Sabahattin Zaim University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zülfünaz ÖZER, Principal Investigator, Istanbul Sabahattin Zaim University
ClinicalTrials.gov Identifier:
NCT05797142
Other Study ID Numbers:
  • 2020-11
First Posted:
Apr 4, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zülfünaz ÖZER, Principal Investigator, Istanbul Sabahattin Zaim University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2023