Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Based Relaxation Program
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Virtual Reality, Anxiety, Pain, Endoscopy Patients
Eligibility Criteria
Inclusion Criteria:
- be18 years and over
- Ability to communicate adequately
- Absence of psychiatric problems
- Those who are determined by the physician that they do not have a physical disability in exercising
- Volunteering to participate in the research
- Individuals who have the ability to use technological tools
Exclusion Criteria:
Those who have communication problems
• Those with psychiatric problems
Sites / Locations
- Firat UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Reality Based Relaxation Program
Control group
Arm Description
Virtual Reality Based Relaxation Program
Routine maintenance will be applied.
Outcomes
Primary Outcome Measures
Visual Analog Scale
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain
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.
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 value.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05585749
Brief Title
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
Official Title
The Effect of Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
With the virtual reality application in patients with bronchoscopy, it is aimed to reduce the fear, stress and tension arising from the possibility of the development of pain and complications in the patients. The research will be carried out in the form of pretest-posttest application with 30 experimental and 30 control groups. The researcher aims to minimize the fear and stress in the patient by applying the virtual reality application to the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during the procedure.
Detailed Description
This study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy. For this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment. The virtual reality environment will be organized on the basis of relaxation exercise. In this direction, first of all, an image will be created by taking 3D modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Virtual Reality, Anxiety, Pain, Endoscopy Patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Virtual Reality Based Relaxation Program
Masking
Participant
Masking Description
Virtual Reality Based Relaxation Program
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Based Relaxation Program
Arm Type
Experimental
Arm Description
Virtual Reality Based Relaxation Program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Based Relaxation Program
Intervention Description
Virtual Reality Based Relaxation Program
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain
Time Frame
1 hours later
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. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.
Time Frame
1 hours later
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 value.
Time Frame
1 hours later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be18 years and over
Ability to communicate adequately
Absence of psychiatric problems
Those who are determined by the physician that they do not have a physical disability in exercising
Volunteering to participate in the research
Individuals who have the ability to use technological tools
Exclusion Criteria:
Those who have communication problems
• Those with psychiatric problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülcan Bahçecioğlu Turan, PhD
Phone
+904242333555
Email
glcnbah@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan Bahçecioğlu Turan, PhD
Organizational Affiliation
Firat University
Official's Role
Study Chair
Facility Information:
Facility Name
Firat University
City
Elazığ
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülcan Bahçecioğlu Turan, PhD
Phone
+904242370000
Email
glcnbah@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hatice Özdemir
Phone
+904242333555
Email
glcnbah@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
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