Virtual RealityNCT05723861
Virtual Reality During Colonoscopy
A study testing VR in people with Virtual Reality and Colonoscopy, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
This project will use a randomized controlled trial to test the effect of using Virtual Reality on pain, anxiety, patients' comfort, and satisfaction during colonoscopy. Patients will use a virtual reality head-mounted display and choose a visualized VR content to watch during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Colonoscopy
- What is being tested?
- VR
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2023to 28 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18
- any elective indication of colonoscopy
Who cannot join
- having visual impairments,
- having dementia
- limited Danish language skills
- a high tendency to travel sickness
- having skin disease in the facial area
- having epilepsy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gastroenterology, Herlev and Gentofte Hospital
Copenhagen, 2730
About this study
This project will use a randomized controlled trial to test the effect of using Virtual Reality on pain, anxiety, patients' comfort, and satisfaction during colonoscopy. Patients will use a virtual reality head-mounted display and choose a visualized VR content to watch during colonoscopy. Colonoscopy will be initiated without standard sedatives and narcotics and using virtual reality distraction for as long as the patient would like (for a maximum of 20 minutes). Participants could opt out and/or request standard medications for pain at any time before or during the procedure.
Read the detailed description
This project aims to investigate the clinical effectiveness and implementation potential of using VR during colonoscopy using a hybrid type 1 effectiveness-implementation design through 2 work packages. The first work package will investigate the effect of VR on pain, anxiety, patients' comfort, and satisfaction during colonoscopy using a multicenter parallel randomized controlled, open-label trial. It will also be a qualitative interview to explore the healthcare professionals' and patients' experiences with using VR during colonoscopy.
The second work package will evaluate the implementation process using mix method to understand why the intervention is (or is not) more effective than usual care, whether high intervention fidelity is achieved, what barriers and facilitators there are, how these may translate into real-world implementation, and what modifications can be made to maximize implementation success. This will be achieved using quantitative and qualitative approaches with a focus on the process evaluation around the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Quantitative (e.g., quantitative analysis of patient participation rate and reasons for refusal assessment or ineligibility) and qualitative (e.g., qualitative interview of facilitators/barriers to implementing VR) data analyses will be combined to conclude the reach, adoption, implementation, and maintenance of the intervention.
The specific aims of the project will be pursued through 2 work packages and include:
Intervention effectiveness work package Study I: To investigate the effect of VR on pain, anxiety, patients' comfort, and satisfaction during colonoscopy.
Study II: To explore the healthcare professionals' and patients' experiences with using VR during colonoscopy.
Implementation work package
Qualitative part:
- To explore facilitators/barriers to adoption and implementing using VR during colonoscopy.
- To explore the facilitators/barriers to sustaining using VR during colonoscopy after the study was completed.
Quantitative part:
- To examine the potential of using VR under colonoscopy for reach and adoption.
Participants will be recruited from adult patients referred to the two outpatient Endoscopy Units. Patients who meet the inclusion criteria and give written consent will be consecutively enrolled in the trial. These patients will be randomly allocated to an experimental group (using VR), or a control group (routine care). Outcomes will be measured immediately before, after, and/or during the procedure.
Some patients in the intervention group and healthcare professionals will be asked to participate in a qualitative interview to share their experiences of using VR under colonoscopy and to evaluate the implementation process.
- Conditions
- Virtual Reality, Colonoscopy
- Being tested
- VR
- Keywords
- Colonoscopy, Virtual Reality, Anxiety, Pain, Patient comfort
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRDevice
We will use the Pico Headset, a three-dimensional Gear with a connected tablet, and will be positioned on the head with elastic straps. Patients will be instructed about the VR device before their procedure and virtual experiences will initiate just before colonoscope insertion and continuously delivered throughout the procedure for max of 20 minutes. Patients will experience max of 20 minutes of VR and if colonoscopy lasts longer than 20 min, the remaining time of colonoscopy will be performed without using VR. The visualized content of VR will be chosen by the participants among three available contents including beach, nature, or mountain with relaxing music. Participants could opt out and/or request standard medications for pain at any time before or during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Participants will receive Virtual Reality intervention in addition to routine care during colonoscopy. Receives: Device: VR |
| Control group | No intervention | Receive routine treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain before colonoscopy procedure
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Measured: 5 - 15 minutes before starting colonoscopy.
Patient pain during colonoscopy procedure
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Measured: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patient pain after colonoscopy procedure
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Measured: 5 - 15 minutes after the colonoscopy is ended.
Patient anxiety before colonoscopy procedure
Patient anxiety will be measured by the short form of the State Trait Anxiety Inventory (STAI) which has five items with a 4-point Likert-type scale ranging from 0 to 3.
Measured: 5 - 15 minutes before starting colonoscopy.
Patient anxiety after colonoscopy procedure
Patient anxiety will be measured by the short form of the State Trait Anxiety Inventory (STAI) which has five items with a 4-point Likert-type scale ranging from 0 to 3.
Measured: 5 - 15 minutes after the colonoscopy is ended.
Patient comfort during colonoscopy procedure
Patient comfort will be measured by a nurse/researcher using the five-point Modified. Gloucester Comfort Scale (MGCS) ranging from 1 (no discomfort) to 5 (severe discomfort).
Measured: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patient comfort after colonoscopy procedure
Patient comfort will be measured by a nurse/researcher using the five-point Modified. Gloucester Comfort Scale (MGCS) ranging from 1 (no discomfort) to 5 (severe discomfort).
Measured: 5 - 15 minutes after the colonoscopy is ended.
Secondary outcomes (2)
Patient satisfaction
Patient satisfaction with the procedure will be measured using an 11-point numeric rating scale ranging from 0 (no satisfaction at all) to 10 (definitely satisfied).
Measured: 5 - 15 minutes after the colonoscopy is ended.
Patient / healthcare professional experience with using VR during colonoscopy
Qualitative interview of some patients in the intervention group and and healthcare professionals.
Measured: 30 minutes - one week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start22 Mar 2023
- Primary completion14 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahdi Shamali, Herlev and Gentofte Hospital
- Investigators
- Mahdi Shamali, PhD, Principal investigator, Herlev and Gentofte University HospitalHanne Konradsen, PhD, Principal investigator, Herlev and Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723861
- Sponsor's protocol ID
- VR2023
- Other IDs
- E 19215 09
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shamali M, Vilmann P, Johansen NR, Konradsen H. Virtual reality intervention to improve quality of care during colonoscopy: a hybrid type 1 randomized controlled trial. Gastrointest Endosc. 2024 Nov;100(5):914-922.e2. doi: 10.1016/j.gie.2024.05.023. Epub 2024 Jun 6.
PubMed 38851457
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality During Colonoscopy
- ClinicalTrials.gov ID
- NCT05723861
- Acronym / sponsor ID
- VR2023
- Conditions
- Virtual Reality, Colonoscopy
- Keywords
- Colonoscopy, Virtual Reality, Anxiety, Pain, Patient comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 13 Feb 2023 (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.
This project will use a randomized controlled trial to test the effect of using Virtual Reality on pain, anxiety, patients' comfort, and satisfaction during colonoscopy. Patients will use a virtual reality head-mounted display and choose a visualized VR content to watch during colonoscopy. Colonoscopy will be initiated without standard sedatives and narcotics and using virtual reality distraction for as long as the patient would like (for a maximum of 20 minutes). Participants could opt out and/or request standard medications for pain at any time before or during the procedure.
Detailed description
This project aims to investigate the clinical effectiveness and implementation potential of using VR during colonoscopy using a hybrid type 1 effectiveness-implementation design through 2 work packages. The first work package will investigate the effect of VR on pain, anxiety, patients' comfort, and satisfaction during colonoscopy using a multicenter parallel randomized controlled, open-label trial. It will also be a qualitative interview to explore the healthcare professionals' and patients' experiences with using VR during colonoscopy.
The second work package will evaluate the implementation process using mix method to understand why the intervention is (or is not) more effective than usual care, whether high intervention fidelity is achieved, what barriers and facilitators there are, how these may translate into real-world implementation, and what modifications can be made to maximize implementation success. This will be achieved using quantitative and qualitative approaches with a focus on the process evaluation around the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Quantitative (e.g., quantitative analysis of patient participation rate and reasons for refusal assessment or ineligibility) and qualitative (e.g., qualitative interview of facilitators/barriers to implementing VR) data analyses will be combined to conclude the reach, adoption, implementation, and maintenance of the intervention.
The specific aims of the project will be pursued through 2 work packages and include:
Intervention effectiveness work package Study I: To investigate the effect of VR on pain, anxiety, patients' comfort, and satisfaction during colonoscopy.
Study II: To explore the healthcare professionals' and patients' experiences with using VR during colonoscopy.
Implementation work package
Qualitative part:
- To explore facilitators/barriers to adoption and implementing using VR during colonoscopy.
- To explore the facilitators/barriers to sustaining using VR during colonoscopy after the study was completed.
Quantitative part:
- To examine the potential of using VR under colonoscopy for reach and adoption.
Participants will be recruited from adult patients referred to the two outpatient Endoscopy Units. Patients who meet the inclusion criteria and give written consent will be consecutively enrolled in the trial. These patients will be randomly allocated to an experimental group (using VR), or a control group (routine care). Outcomes will be measured immediately before, after, and/or during the procedure.
Some patients in the intervention group and healthcare professionals will be asked to participate in a qualitative interview to share their experiences of using VR under colonoscopy and to evaluate the implementation process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: VRParticipants will receive Virtual Reality intervention in addition to routine care during colonoscopy. |
| Control group | No intervention | –Receive routine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18
- any elective indication of colonoscopy
Key exclusion criteria (6 listed)
- having visual impairments,
- having dementia
- limited Danish language skills
- a high tendency to travel sickness
- having skin disease in the facial area
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 |
|---|---|---|
| VRWe will use the Pico Headset, a three-dimensional Gear with a connected tablet, and will be positioned on the head with elastic straps. Patients will be instructed about the VR device before their procedure and virtual experiences will initiate just before colonoscope insertion and continuously delivered throughout the procedure for max of 20 minutes. Patients will experience max of 20 minutes of VR and if colonoscopy lasts longer than 20 min, the remaining time of colonoscopy will be performed without using VR. The visualized content of VR will be chosen by the participants among three available contents including beach, nature, or mountain with relaxing music. Participants could opt out and/or request standard medications for pain at any time before or during the procedure. | Device | VR group |
Primary outcome
Patient pain before colonoscopy procedure
Time frame: 5 - 15 minutes before starting colonoscopy.
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Patient pain during colonoscopy procedure
Time frame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Patient pain after colonoscopy procedure
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patients will rate their pain using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (highest imaginable pain).
Patient anxiety before colonoscopy procedure
Time frame: 5 - 15 minutes before starting colonoscopy.
Patient anxiety will be measured by the short form of the State Trait Anxiety Inventory (STAI) which has five items with a 4-point Likert-type scale ranging from 0 to 3.
Patient anxiety after colonoscopy procedure
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient anxiety will be measured by the short form of the State Trait Anxiety Inventory (STAI) which has five items with a 4-point Likert-type scale ranging from 0 to 3.
Patient comfort during colonoscopy procedure
Time frame: During the colonoscopy procedure (from the time colonoscopy is started until ended).
Patient comfort will be measured by a nurse/researcher using the five-point Modified. Gloucester Comfort Scale (MGCS) ranging from 1 (no discomfort) to 5 (severe discomfort).
Patient comfort after colonoscopy procedure
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient comfort will be measured by a nurse/researcher using the five-point Modified. Gloucester Comfort Scale (MGCS) ranging from 1 (no discomfort) to 5 (severe discomfort).
2 secondary outcomes
Patient satisfaction
Time frame: 5 - 15 minutes after the colonoscopy is ended.
Patient / healthcare professional experience with using VR during colonoscopy
Time frame: 30 minutes - one week after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 38851457Shamali M, Vilmann P, Johansen NR, Konradsen H. Virtual reality intervention to improve quality of care during colonoscopy: a hybrid type 1 randomized controlled trial. Gastrointest Endosc. 2024 Nov;100(5):914-922.e2. doi: 10.1016/j.gie.2024.05.023. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
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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.
Mahdi Shamali, PhD principal investigator
Herlev and Gentofte University Hospital
Hanne Konradsen, PhD principal investigator
Herlev and Gentofte University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR in people with Virtual Reality and Colonoscopy, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jul 2023. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient pain before colonoscopy procedure (time frame: 5 - 15 minutes before starting colonoscopy.). The study lists 7 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 NCT05723861, which also lists 1 linked publication.
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 3 Jul 2023.