Back to resultsVirtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy
Primary Purpose
Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality glasses
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring virtual reality glasses, Pain, Anxiety, Endoscopy
Eligibility Criteria
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
Sites / Locations
- Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
: Virtual reality glasses
Control group
Arm 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, with a music background, licensed product "Secret Garden", during the procedure (30 minutes).
Routine maintenance will be applied
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05797142
First Posted
March 10, 2023
Last Updated
April 3, 2023
Sponsor
Istanbul Sabahattin Zaim University
1. Study Identification
Unique Protocol Identification Number
NCT05797142
Brief Title
Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sabahattin Zaim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
Keywords
virtual reality glasses, Pain, Anxiety, Endoscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental study with pre-test and post-test control groups
Masking
Participant
Masking Description
Virtual reality glasses and control group
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
: Virtual reality glasses
Arm Type
Experimental
Arm 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, with a music background, licensed product "Secret Garden", during the procedure (30 minutes).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied
Intervention Type
Other
Intervention Name(s)
Virtual reality glasses
Intervention 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, with a music background, licensed product "Secret Garden", during the procedure (30 minutes).
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Baseline (Before endoscopy)
Title
Visual Analog Scale
Description
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.
Time Frame
5 minute after endoscopy
Secondary Outcome Measure Information:
Title
Anxiety Assessment Scale
Description
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.
Time Frame
Baseline (Before endoscopy)
Title
Anxiety Assessment Scale
Description
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.
Time Frame
5 minute after endoscopy
Title
Physiological Symptoms of Anxiety Follow-up Form
Description
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.
Time Frame
Baseline (Before endoscopy)
Title
Physiological Symptoms of Anxiety Follow-up Form
Description
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.
Time Frame
1 minute after endoscopy
Title
Virtual Reality Glasses Application Satisfaction Form
Description
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.
Time Frame
5 minute after endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zülfünaz Özer, PhD
Organizational Affiliation
Istanbul Sabahattin Zaim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
City
Istanbul
State/Province
Turkiye
ZIP/Postal Code
340340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35397973
Citation
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.
Results Reference
result
Learn more about this trial
Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy
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