- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407531
Before Colonoscopy Effect of Virtual Reality Application on Anxiety and Vital Signs
Examining the Effect of Virtual Reality Application on Patient's Anxiety and Vital Signs Before Colonoscopy: A Randomized Controlled Study
This study was planned to examine the effect of virtual reality application on the patient's anxiety and vital signs before colonoscopy. The hypotheses of the research are as follows:
H1: Virtual reality application before colonoscopy has an effect on patients' anxiety and vital signs.
H0: Virtual reality application before colonoscopy has no effect on patients' anxiety and vital signs.
Before colonoscopy, patients in the study group will be asked to watch videos using virtual reality glasses.
Study Overview
Detailed Description
After obtaining the ethics committee and institutional permission for the research, the researcher was taken to the hospital for the colonoscopy procedure.
He/she will introduce himself/herself to the patients and explain the purpose of the research. Patients who volunteered to participate in the study Informed consent will be obtained. Data regarding the socio-demographic characteristics of the patients included in the patient introduction form The patient will be interviewed face to face, and data regarding the patients' clinical characteristics will be recorded from the patient file. colonoscopy Data will begin to be collected from the first patient to undergo the procedure. Anxiety and life assessment with VAS 30 minutes before the procedure The findings will be considered. According to the randomization, the patient in the virtual reality glasses group was first asked by the researcher.
It will be explained to the patient that he will wear the glasses for 30 minutes and watch a video before the procedure. By researcher 30 When the minute is up, the patient will be informed and asked to remove the glasses. No intervention was made to the patient in the control group.
It will not be done. Anxiety and vital signs were measured with VAS 5-10 minutes before the procedure began in all patient groups.
will be looked into. After each patient use, the virtual reality glasses will be cleaned and dried with alcohol-based cleaning material.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seda Cansu Yeniğün, PhD
- Phone Number: 05077286208
- Email: seda.cansu.yenigun@gmail.com
Study Contact Backup
- Name: Seher Ünver, PhD
- Phone Number: 0 (505) 500 72 17
- Email: seherunver@trakya.edu.tr
Study Locations
-
-
Finike
-
Antalya, Finike, Turkey, 07740
- Recruiting
- Finike State Hospital
-
Contact:
- Yüksel Kurt, Doktor
- Phone Number: (0242) 855 20 00
- Email: finikedevlethastanesi@hs01.kep.tr
-
Principal Investigator:
- Seda Cansu Yeniğün, PhD
-
Principal Investigator:
- Seher Ünver, PhD
-
Principal Investigator:
- Hatice Merve Alptekin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the research,
- Being literate,
- Be 18 years or older.
Exclusion Criteria:
- Performing colonoscopy at the same time as endoscopy,
- Using any analgesic or anxiolytic,
- Having a visual or hearing impairment,
- Performing an emergency colonoscopy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR-G
The patient will wear virtual glasses and watch a video 30 minutes before the procedure.
|
Patients watched videos with virtual glasses before undergoing colonoscopy
|
No Intervention: Control
No intervention will be performed on control group patients and the standard care protocol of the clinic will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety (Visual Analog Scale-Anxiety)
Time Frame: 30 minutes before colonoscopy
|
Patients' anxiety will be evaluated (0-10 point).
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
|
30 minutes before colonoscopy
|
Anxiety (Visual Analog Scale-Anxiety)
Time Frame: 5-10 minutes before colonoscopy
|
Patients' anxiety will be evaluated (0-10 point).
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
|
5-10 minutes before colonoscopy
|
Systolic blood pressure
Time Frame: 30 minutes before colonoscopy
|
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
|
30 minutes before colonoscopy
|
Systolic blood pressure
Time Frame: 5-10 minutes before colonoscopy
|
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
|
5-10 minutes before colonoscopy
|
Diastolic blood pressure
Time Frame: 30 minutes before colonoscopy
|
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
|
30 minutes before colonoscopy
|
Diastolic blood pressure
Time Frame: 5-10 minutes before colonoscopy
|
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
|
5-10 minutes before colonoscopy
|
Heart rate
Time Frame: 5-10 minutes before colonoscopy
|
In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.
|
5-10 minutes before colonoscopy
|
Heart rate
Time Frame: 30 minutes before colonoscopy
|
In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.
|
30 minutes before colonoscopy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VRG208
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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