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Clinical Trial NCT06333418 (VR/WN_colon) for Misadventure During Endoscopic Examination is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effects of VR and Glass WF Colonoscopy (VR/WN_colon) 135 Virtual

Not yet recruiting
Clinical Trial NCT06333418 (VR/WN_colon) is an interventional study for Misadventure During Endoscopic Examination and is currently not yet recruiting. Enrollment is planned to begin on April 3, 2024 and continue until the study accrues 135 participants. Led by Suleyman Demirel University, this study is expected to complete by June 8, 2024. The latest data from ClinicalTrials.gov was last updated on March 27, 2024.
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...

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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...

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Official Title

The Effect of Virtual Rain Forest and Glass Waterfall on Satisfaction, Comfort, Anxiety, and Vital Signs Undergoing Colonoscopy

Conditions
Misadventure During Endoscopic Examination
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • VR/WN_colon
  • VR/WF
NCT ID Number
Start Date (Actual)
2024-04-03
Last Update Posted
2024-03-27
Completion Date (Estimated)
2024-06-08
Enrollment (Estimated)
135
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
virtual reality
glass waterfall
satisfaction
comfort
colonoscopy
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVirtual Reality Glasses
Before the colonoscopy procedure, 360-degree VR video scenes will be watched to patients 30 minutes using VR head device.
Virtual Reality Glasses Group
Before the colonoscopy procedure, 360-degree VR video scenes will be watched to patients 30 minutes using VR head device.
ExperimentalGlass waterfall
Before the colonoscopy procedure, patients will watch and listen 30 minutes a portative glass waterfall
Glass waterfall
Before the colonoscopy procedure, patients will watch and listen 30 minutes a portative glass waterfall
No Interventioncontrol group
Patients of the control group, will not receive any intervention except for applied routine hospital colonoscopy procedures
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Patient Information Form
This form, which will be created by the researcher; Patients' age, gender, education level, marital status, employment status, income level, chronic disease status, previous surgery, complaints about coming to the hospital, having knowledge about colonoscopy, whether they would prefer the current method if they need to have colonoscopy again, It consists of a total of 14 questions questioning the use of additional sedation and painkillers during the procedure
the fundamental characteristics of the patients will be filled in 40 minutes before the colonoscopy procedure
Visual Analogue Scale (VAS)
This scale developed by Price (1983) will be used in the research to determine the level of tolerance, comfort and satisfaction. It is a scale in which the distance between the two ends with a minimum value of 0 on one end and a maximum value of 10 on the other end is measured with a 10 cm ruler. In this context; The patient is explained that there are two endpoints and that he is free to mark any place between them that fits the severity of his pain. The distance between the beginning of "no comfort, tolerance and satisfaction" and this point marked by the patient is measured and recorded in centimeters. It has been shown that the VAS is a valid tool for the measurement of psychological and health variables such as pain and satisfaction, which is widely used in clinical studies
Change from Baseline Visual Analogue Scale in 50 minutes
State and Trait Anxiety Scale (STAI)
It is a self-assessment questionnaire developed by Spielberger et al. and consists of short assessments. The STAI includes 40 four-point Likert-type items ranging from "None" to "Completely". The validity and reliability of the STAI in Turkey were established by Öner and Le Compte. The STAI includes two separate scales, the State Anxiety Score (SAS) and the Trait Anxiety Score (TAS). The SAS requires the person to describe how they feel at a certain moment and under certain conditions and to respond by taking into account their feelings about the situation they are in. On the other hand, the TAS requires the person to describe how they usually feel. Higher scores indicate increased anxiety level. In the Turkish validity and reliability study, Cronbach's alpha reliability coefficients were between 0.83 and 0.87 for the TAS and between 0.94 and 0.96 for the SAS.
Change from Baseline The State and Trait Anxiety Scale in 50 minutes
The Patient Observation Form
This form will be created by the researcher based on the literature review, the vital signs (pulse (min), respiratory rate (min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and oxygen saturation values (%)) of the patients before and after the procedure will be recorded the form. Researcher will has a automatic blood pressure monitor and a probe device for recording vital signs in the endoscopy unit. While the patients' vital signs will being taken, a fully automatic blood pressure monitor will be used to measure blood pressure and pulse. To measure the respiratory rate, the patient placed his hand on his chest and his chest movements will be counted and recorded for one minute. Oxygen saturation level will be measured from the index finger with a probe device.Data will be collected by recording all vital measurement values on a single form. The form will similar to forms commonly used in nursing research for patient vital signs.
Change from Baseline The Patient Observation Form in 50 minutes
Pulse rate before colonoscopy procedure
60 to 100 beats per minute is normal. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure
Change from Baseline Pulse rate in 50 minutes
Respiratory rate before colonoscopy procedure
12 to 18 breaths per minute is normal. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure
Change from Baseline Respiratory rate in 50 minutes
Systolic and diastolic blood pressure before colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure
Change from Baseline Systolic and diastolic blood pressure in 50 minutes
Oxygen saturation values before colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure
Change from Baseline Oxygen saturation values in 50 minutes
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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,
Suleyman Demirel University logoSuleyman Demirel University
Study Responsible Party
Hasan Genç, Principal Investigator, Asistant Professor, Dicle University
Study Central Contact
Contact: Hasan GENC, PhD, +0955319887307, [email protected]
No location data.