Misadventure During Endoscopic ExaminationVR_COLONNCT05410184
Effects of VR and Mural Curtain During Colonoscopy
A study testing Virtual Reality Glasses group and mural curtain group in people with Misadventure During Endoscopic Examination, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Misadventure During Endoscopic Examination
- What is being tested?
- Virtual Reality Glasses group and mural curtain group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, 32260
Altun Baksi, Assoc. Prof., PhD, 05053973246, altun.baksi@hotmail.com
Hasan Genç, Asist. Prof., PhD, +905319887307, hasangenc4721@hotmail.com
About this study
Official title: The Effect of Virtual Reality Glasses and Application of Mural Curtain on Satisfaction, Tolerance, Comfort and Embarrassment During Colonoscopy
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. .
- Being tested
- Virtual Reality Glasses group, mural curtain group
- Keywords
- virtual reality, tolerance, embarrassment, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Glasses groupDevice
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 groupOther
the mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses | Experimental | 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. Receives: Device: Virtual Reality Glasses group |
| Mural Curtain | Experimental | the mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure. Receives: Other: mural curtain group |
| control group | No intervention | Patients of the control group, will not receive any intervention except for applied routine hospital colonoscopy procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
This form, which was 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
Measured: the fundamental characteristics of the patients will be filled in 15 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 (12).
Measured: Change from Baseline Visual Analogue Scale in 1 hour
The Colonoscopy Shame Scale
this scale was developed in the United States in 2012 by Kimberly A. Mitchell and colleagues for the use of healthcare professionals. The scale consists of 15 questions examining the reasons why patients are ashamed of colonoscopy. For the statements in the scale, the participants mark the most appropriate answer for their own thoughts on a scale between 1 and 4 (strongly disagree=1, disagree=2, agree=3, totally agree=4). The lowest score that can be obtained from the total scale is 15, the highest score is 60. Higher scores indicate more embarrassment. The Cronbach's alpha coefficient of the original scale was 0.96. The validity and reliability study in Turkey was conducted by Koroglu in 2014 and the Cronbach's alpha coefficient of the scale was found to be 0.94 (11, 13).
Measured: Change from Baseline The Colonoscopy Shame Scale in 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start27 Jun 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Misadventure During Endoscopic ExaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental model using randomized pretest and posttest with control group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Genç, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410184
- Sponsor's protocol ID
- vr/curtain colon
- Acronym
- VR_COLON
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all IPD that underlie results in a publication
Publications
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.
PubMed 32056820Rostom 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.
PubMed 23317691Bronner 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.
PubMed 23916675Umezawa 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.
PubMed 25914482Veldhuijzen 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.
PubMed 32626819Diette 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.
PubMed 12628899
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses and Application of Mural Curtain on Satisfaction, Tolerance, Comfort and Embarrassment During Colonoscopy
- ClinicalTrials.gov ID
- NCT05410184
- Acronym / sponsor ID
- VR_COLON / vr/curtain colon
- Keywords
- virtual reality, tolerance, embarrassment, satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 27 Jun 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- experimental model using randomized pretest and posttest with control group
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses | Experimental | Device: Virtual Reality Glasses groupExcept 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 | Experimental | Other: mural curtain groupthe mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure. |
| control group | No intervention | –Patients of the control group, will not receive any intervention except for applied routine hospital colonoscopy procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Glasses groupExcept 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 | Device | Virtual Reality Glasses |
| mural curtain groupthe mural curtain group; they will be asked to focusing the mural curtain with a nature view during the colonoscopy procedure. | Other | Mural Curtain |
Primary outcome
Patient Information Form
Time frame: the fundamental characteristics of the patients will be filled in 15 minutes before the colonoscopy procedure
This form, which was 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
Visual Analogue Scale (VAS)
Time frame: Change from Baseline Visual Analogue Scale in 1 hour
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 (12).
The Colonoscopy Shame Scale
Time frame: Change from Baseline The Colonoscopy Shame Scale in 1 hour
this scale was developed in the United States in 2012 by Kimberly A. Mitchell and colleagues for the use of healthcare professionals. The scale consists of 15 questions examining the reasons why patients are ashamed of colonoscopy. For the statements in the scale, the participants mark the most appropriate answer for their own thoughts on a scale between 1 and 4 (strongly disagree=1, disagree=2, agree=3, totally agree=4). The lowest score that can be obtained from the total scale is 15, the highest score is 60. Higher scores indicate more embarrassment. The Cronbach's alpha coefficient of the original scale was 0.96. The validity and reliability study in Turkey was conducted by Koroglu in 2014 and the Cronbach's alpha coefficient of the scale was found to be 0.94 (11, 13).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 32056820Celebi 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.
- Background: PubMed 23317691Rostom 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.
- Background: PubMed 23916675Bronner 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.
- Background: PubMed 25914482Umezawa 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.
- Background: PubMed 32626819Veldhuijzen 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.
- Background: PubMed 12628899Diette 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.
- Individual participant dataSharing planned: Undecided. all IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses group and mural curtain group in people with Misadventure During Endoscopic Examination, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: the fundamental characteristics of the patients will be filled in 15 minutes before the colonoscopy procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410184, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.