Clinical trial NCT06333418: Effects of VR and Glass WF Colonoscopy
Official title: The Effect of Virtual Rain Forest and Glass Waterfall on Satisfaction, Comfort, Anxiety, and Vital Signs Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Misadventure During Endoscopic Examination
Keywords: virtual reality
glass waterfall
satisfaction
comfort
colonoscopy
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment experimental model using randomized pretest and posttest with control group
Primary purpose: SUPPORTIVE_CARE

Brief 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 fear, and anxiety in the patient.

Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 135 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 135 individuals for the three groups and at 60 individuals for each group. G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 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. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information.

Detailed description: 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 fear, and anxiety in the patient.

Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who will apply to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and will be scheduled for colonoscopy. The sample will be represented by 135 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 will be performed and it will be found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 135 individuals for the three groups and at 60 individuals for each group. G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 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. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information. Before the colonoscopy procedure, 360-degree VR rain forest video scenes will be watched 30 minutes using VR head device in virtual glasses group. Glass Water group, patients will watch and listen 30 minutes a portative glass waterfall

Eligibility criteria: 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,

Primary outcomes:
measure: Patient Information Form
timeFrame: the fundamental characteristics of the patients will be filled in 40 minutes before the colonoscopy procedure
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline Visual Analogue Scale in 50 minutes
measure: State and Trait Anxiety Scale (STAI)
timeFrame: Change from Baseline The State and Trait Anxiety Scale in 50 minutes
measure: The Patient Observation Form
timeFrame: Change from Baseline The Patient Observation Form in 50 minutes
measure: Pulse rate before colonoscopy procedure
timeFrame: Change from Baseline Pulse rate in 50 minutes
measure: Respiratory rate before colonoscopy procedure
timeFrame: Change from Baseline Respiratory rate in 50 minutes
measure: Systolic and diastolic blood pressure before colonoscopy procedure
timeFrame: Change from Baseline Systolic and diastolic blood pressure in 50 minutes
measure: Oxygen saturation values before colonoscopy procedure
timeFrame: Change from Baseline Oxygen saturation values in 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dicle University
name: Hasan GENC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rostom A, Ross ED, Dube C, Rutter MD, Lee T, Valori R, Bridges RJ, Pontifex D, Webbink V, Rees C, Brown C, Whetter DH, Kelsey SG, Hilsden RJ. Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest Endosc. 2013 Feb;77(2):255-61. doi: 10.1016/j.gie.2012.10.003.
citation: Dogan Yilmaz E, Unlusoy Dincer N. The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):318-328. doi: 10.1097/SGA.0000000000000733. Epub 2023 Jun 5.