Before Colonoscopy Effect of Virtual Reality Application on Anxiety and Vital Signs

May 10, 2024 updated by: Seda Cansu Yeniğün, Akdeniz University

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

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Finike
      • Antalya, Finike, Turkey, 07740
        • Recruiting
        • Finike State Hospital
        • Contact:
        • Principal Investigator:
          • Seda Cansu Yeniğün, PhD
        • Principal Investigator:
          • Seher Ünver, PhD
        • Principal Investigator:
          • Hatice Merve Alptekin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

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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