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Effects of VR and Mural Curtain During Colonoscopy

NCT05410184 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-06-13

No results posted yet for this study

Summary

Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as embarrassment, fear, and anxiety in the patient.

Purpose: To examine the effects of virtual reality glasses and video surveillance and picture screen application applied during colonoscopy on patients' satisfaction, tolerance, comfort and sense of shame.

Method: The population of the study consists of all patients who applied to Suleyman Demirel University Research and Practice Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 180 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 180 individuals for the three groups and at 60 individuals for each group. As a result, the sample of the research will consist of 180 people, 60 of whom are in the video with VR glasses, 60 people are in the mural curtain group and 60 people are in the control group. The study group of 180 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer-based Research Randomizer program. Data will be collected in the endoscopy unit on weekdays when the procedure is performed. The person who will collect the data is the endoscopy nurse working in the unit, one of the researchers. Colonoscopy procedure will be performed by the physician working in the unit, who is also one of the researchers. Before the colonoscopy procedure, the patients included in the study will be randomly divided into three groups: video group with VR, mural curtain group and control group. All participants in the study will first fill out a patient identification form containing patient demographic information. .

Conditions

  • Misadventure During Endoscopic Examination

Interventions

DEVICE

Virtual Reality Glasses group

Except for the preparation of the patient for the procedure, since the colonoscopy procedure takes approximately 30 minutes, 30-minute 360-degree VR video scenes will be watched using the phone and VR head device

OTHER

mural curtain group

the mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure.

Sponsors & Collaborators

  • Suleyman Demirel University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2022-11-30
Completion
2022-12-30

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 NCT05410184 on ClinicalTrials.gov