The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level

NCT04710121 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-01-14

No results posted yet for this study

Summary

The study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses used during a colonoscopy on vital signs, pain, and anxiety level. After the approval of the ethics committee and institutional permission, 60 patients who applied to the endoscopy unit for colonoscopy procedure between 1 October 2020 and 1 October 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0,665 (effect size), α = 0.05 (margin of error), 1-β = 0.80 (Power) and by using the G-Power package program with the specified criteria. It was decided to recruit 58 people (29 people per group). The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Before the colonoscopy, the patient will be visited and information will be given about the purpose, content, and intervention to be applied. After obtaining verbal and written consent from the patients who accepted to participate in the study, the "Individual Characteristics Form" will be filled. Then, before the colonoscopy procedure, the anxiety states of the patients in the experimental and control groups will be asked with the "State and Trait Anxiety Inventory", their pain status with the Analog Scale (VAS), and their first life findings will be measured and the first measurement values will be recorded in the "Vital Signs Follow-up Form".

The patients in the experimental group will be informed about the virtual glasses before the colonoscopy procedure and the virtual reality glasses will be placed on the patient's head during the procedure. Then, during the colonoscopy procedure, the duration of the colonoscopy will vary between 3-10 minutes, and during the colonoscopy period, videos with music background, parks, nature and seaside walks, underwater, etc., will be watched by the patient and the "Vital Signs Tracking Form" The second measurement values will be saved by making measurement to.

Immediately after the colonoscopy procedure is finished, "Visual Analogue Scale (VAS)", "Life Findings Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. The standard application will be applied to the patients in the control group during the colonoscopy procedure and the second measurement values will be recorded by measuring the "Vital Signs Follow-up Form".Immediately after the colonoscopy procedure is completed, the third measurement value will be recorded by measuring the "Visual Analogue Scale (VAS)" and "Vital Signs Follow-up Form". "State Anxiety Inventory" will be read and the answers recorded.

Conditions

  • Colonoscopy

Interventions

OTHER

Virtual Reality Glasses

Virtual Reality Glasses (VRG), one of the methods of distracting attention; widely used in clinical medical care to relieve symptoms by providing the opportunity to create therapeutic environments for the evaluation and treatment of medical conditions. Virtual reality is a computer simulation technique that enables individuals to hear and feel the sounds and corresponding stimuli accompanying the visual image through headphones. The most basic feature that distinguishes virtual reality (VR) glasses from similar applications is that it gives individuals a real feeling. VR has helped to distract patients from mental processing and reduce the amount of pain. Virtual reality glasses, which are inexpensive to apply and use, do not cause side effects, and can be used in the recovery of the individual, are an intervention that can be preferred in nursing practices.

Sponsors & Collaborators

  • Esra KILINÇ AKMAN

    lead OTHER

Principal Investigators

  • Ayfer ÖZBAŞ, Prof · Istanbul University - Cerrahpasa

  • Esra KILINÇ AKMAN, MSC · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2021-06-20
Completion
2021-12-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710121 on ClinicalTrials.gov