Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
180 participants
INTERVENTIONAL
2022-06-27
2022-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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. .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy
NCT06003543
Effects of VR and Glass WF Colonoscopy
NCT06333418
The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level
NCT04710121
Before Colonoscopy Effect of Virtual Reality Application on Anxiety and Vital Signs
NCT06407531
The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy
NCT05027659
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual Reality Glasses
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.
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
Mural Curtain
the mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure.
mural curtain group
the mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure.
control group
Patients of the control group, will not receive any intervention except for applied routine hospital colonoscopy procedures.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
mural curtain group
the mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
* Diagnosed with visual, auditory and / or balance disorders,
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Suleyman Demirel University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hasan Genç
Asistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Suleyman Demirel University
Isparta, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.
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.
Bronner K, Mesters I, Weiss-Meilik A, Geva R, Rozner G, Strul H, Inbar M, Halpern Z, Kariv R. Determinants of adherence to screening by colonoscopy in individuals with a family history of colorectal cancer. Patient Educ Couns. 2013 Nov;93(2):272-81. doi: 10.1016/j.pec.2013.06.029. Epub 2013 Aug 2.
Umezawa S, Higurashi T, Uchiyama S, Sakai E, Ohkubo H, Endo H, Nonaka T, Nakajima A. Visual distraction alone for the improvement of colonoscopy-related pain and satisfaction. World J Gastroenterol. 2015 Apr 21;21(15):4707-14. doi: 10.3748/wjg.v21.i15.4707.
Veldhuijzen G, Klaassen NJM, Van Wezel RJA, Drenth JPH, Van Esch AA. Virtual reality distraction for patients to relieve pain and discomfort during colonoscopy. Endosc Int Open. 2020 Jul;8(7):E959-E966. doi: 10.1055/a-1178-9289. Epub 2020 Jun 30.
Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
vr/curtain colon
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.