Effects of VR and Mural Curtain During Colonoscopy (VR_COLON)

Suleyman Demirel University

Status: Not yet enrolling

Conditions: Misadventure During Endoscopic Examination

Treatments: Other: mural curtain group; Device: Virtual Reality Glasses group

Study type: Interventional

Funder types: Other

Identifiers

NCT05410184

vr/curtain colon

Details and patient eligibility

About

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. .

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 aged and over
• Written and verbal consent to participate in the study,
• Being conscious (person, place and time orientation),
• Undergoing colonoscopy for the first time

Exclusion criteria

• Having vision, hearing and communication problems
• Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
• Diagnosed with visual, auditory and / or balance disorders,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Virtual Reality Glasses

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality Glasses group

Mural Curtain

Experimental group

Description:

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

Treatment:

Other: mural curtain group

control group

No Intervention group

Description:

Patients of the control group, will not receive any intervention except for applied routine hospital colonoscopy procedures.