AnxietyNCT06171620
Virtual Sedation During Elective Procedures in the Cathlab
A study testing Virtual reality headset in people with Anxiety and Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2023to 29 Feb 2024
- 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
- Undergoing elective procedure in line with the following criteria in the cathlab of the UZB: limited feedback requirements from the patient to the physician, per-formed under local anaesthesia, risk estimated as normal i.e. haemodynamically stable patients (Stable vital signs such as heart rate and blood pressure) and no expected complications, electively planned and duration expected to be between 30 minutes and two hours.
- Agreeing to participate via signed informed consent.
- Being at least 18 years of age.
- Being fluent in either English, French or Dutch language.
Who cannot join
- Ailments which would make wearing of the headset uncomfortable or impossible.
- cognitive impairment such as dementia or delirium.
- Severe hearing impairment, as this will limit the immersion.
- Severe visual impairment not compensated by glasses, such as blindness.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, Jette, 1090
Karen VandenBussche, PHD, 02 477 60 09, Karen.VanDenBussche@UZBrussel.be
Pieter-Jan Goossens, BS, 02 477 60 09, PieterJan.Goossens@UGent.be
About this study
Official title: Virtual Reality as a Non-pharmacological Tool for Pain and Anxiety Relief During Elective Procedures in the Cathlab
This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab).
To assess the effectiveness of VR in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. A sample of patients scheduled for a planned procedure in the cathlab of UZ Brussel will be selected using convenience sampling.
Read more
Participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. The control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention.
The primary outcome of anxiety will be measured using the Visual Analog Scale (VAS) for anxiety and the State-Trait Anxiety Inventory (STAI) questionnaire. The secondary outcome of pain will be measured using the VAS scale for pain.
Other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. The physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the VR headset from the operators' perspective.
The outcomes of the two groups will be statistically compared using the SPSS software package.
- Being tested
- Virtual reality headset, Standard of care
- 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.
Virtual reality headsetDevice
Distraction therapy using a virtual reality headset. Participants will access a digitally created environment such as a forest or sub sea exploration with relaxing auditory cues.
Standard of careOther
Elective procedure performed as planned according to current standard of care in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Control group (SOC) | Other | Standard of care Receives: Other: Standard of care |
| Intervention Group (VR) | Experimental | Standard of care with addition of the Virtual reality headset Receives: Device: Virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
perioperative anxiety consisting of State, trait anxiety and anxiety experienced during the procedure.
State anxiety: level of anxiety a person experiences in the current moment. Trait anxiety: Level of anxiety a person experiences in general, how anxious a person is in general.
State and trait anxiety will be measured using the state trait anxiety inventory questionnaire consisting of 20 questions for state anxiety and 20 questions for trait anxiety. The questions are answered in the form of Likert scales ranging from 1 to 4.
Anxiety experienced during the procedure will be measured using the visual analogue scale (VAS) which ranges from 0 (none) to 100 mm (worst imaginable).
Measured: State trait: 30 minutes pre operatively and 5 minutes post operatively. Anxiety using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
Pain experienced during the procedure
The level of pain a patient experienced throughout the elective procedure measured using the Visual analogue scale (VAS) which ranges from 0 (none) to 100 mm (worst imaginable).
Measured: using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
Secondary outcomes (8)
Procedural comfort
Patient experience during the elective procedure. This will be assessed by a custom patient questionnaire with the question: how was your experience during the procedure? The answer will be in the form of a scale ranging from 1 (very uncomfortable) to 10 (very comfortable).
This questionnaire will be given to the patient 5 minutes after the end of the procedure.
Measured: 5 minutes after the procedure
Operator comfort (nurses and doctors).
How the nurses and doctors experienced the procedure and level of support they needed to provide the patient.
This will be assessed by a custom questionnaire with the question: To what degree did you need to provide reassurance to the patient during this procedure? The answer will be in the form of a Likert scale ranging from 1 (No reassurance needed) to 5 (Continuous reassurance needed).
This questionnaire will be given to the patient 5 minutes after the end of the procedure.
Measured: 5 minutes after the procedure.
Nausea
The level of nausea (If any) a patient experienced during the procedure. This will be assessed by a custom questionnaire with the question: to what degree did you experience nausea during this procedure? The answer will be in the form of a scale ranging from 0 (none) to 10 (severe).
This questionnaire will be given to the patient 5 minutes after the end of the procedure.
Measured: 5 minutes after the procedure
Systolic blood pressure
The systolic blood pressure will be measured none invasively every 15 minutes during the procedure using the M540 infinity monitoring system by Dräger.
Measured: At the start of the procedure and every 15 minutes.
Diastolic blood pressure
The Diastolic blood pressure will be measured none invasively every 15 minutes during the procedure using the M540 infinity monitoring system by Dräger.
Measured: At the start of the procedure and every 15 minutes.
Mean Blood pressure
The mean blood pressure will be measured none invasively every 15 minutes during the procedure using the M540 infinity monitoring system by Dräger.
Measured: At the start of the procedure and every 15 minutes.
Heart rate
Heart rate will be measured every 15 minutes alongside the NIBP. This will be done by using both the pulse oximetry device and ECG monitoring system from Philips.
Measured: At the start of the procedure and every 15 minutes.
Satisfaction with VR (for patient, nurses and doctors)
Satisfaction with VR will be assessed by a custom questionnaire with the following questions:
- Was the VR headset an added value for you during this procedure?
- To which degree would you recommend the use of the VR headset during this procedure?
These questions are answered by Likert scales ranging from 1 (none at all) to 5 (greatly so).
The questionnaires include several open ended questions for potential problems that occurred due to the presence of the VR headset and any personal remarks.
Measured: 5 minutes 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 posted14 Dec 2023
- Study start26 Jun 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group design, Standard of care (control) vs Standard of care + VR intervention (Intervention group)
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Johan De Sutter, PHD, MD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171620
- Sponsor's protocol ID
- 22283VR Cathlab
- Status last verified
- Aug 2023
- First submitted
- 8 Sep 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Non-pharmacological Tool for Pain and Anxiety Relief During Elective Procedures in the Cathlab
- ClinicalTrials.gov ID
- NCT06171620
- Acronym / sponsor ID
- 22283VR Cathlab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 14 Dec 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 study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab).
To assess the effectiveness of VR in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. A sample of patients scheduled for a planned procedure in the cathlab of UZ Brussel will be selected using convenience sampling.
Participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. The control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention.
The primary outcome of anxiety will be measured using the Visual Analog Scale (VAS) for anxiety and the State-Trait Anxiety Inventory (STAI) questionnaire. The secondary outcome of pain will be measured using the VAS scale for pain.
Other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. The physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the VR headset from the operators' perspective.
The outcomes of the two groups will be statistically compared using the SPSS software package.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group design, Standard of care (control) vs Standard of care + VR intervention (Intervention group)
| Arm | Type | Receives |
|---|---|---|
| Control group (SOC) | Other | Other: Standard of careStandard of care |
| Intervention Group (VR) | Experimental | Device: Virtual reality headsetStandard of care with addition of the Virtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective procedure in line with the following criteria in the cathlab of the UZB: limited feedback requirements from the patient to the physician, per-formed under local anaesthesia, risk estimated as normal i.e. haemodynamically stable patients (Stable vital signs such as heart rate and blood pressure) and no expected complications, electively planned and duration expected to be between 30 minutes and two hours.
- Agreeing to participate via signed informed consent.
- Being at least 18 years of age.
- Being fluent in either English, French or Dutch language.
Key exclusion criteria (4 listed)
- Ailments which would make wearing of the headset uncomfortable or impossible.
- cognitive impairment such as dementia or delirium.
- Severe hearing impairment, as this will limit the immersion.
- Severe visual impairment not compensated by glasses, such as blindness.
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 headsetDistraction therapy using a virtual reality headset. Participants will access a digitally created environment such as a forest or sub sea exploration with relaxing auditory cues. | Device | Intervention Group (VR) |
| Standard of careElective procedure performed as planned according to current standard of care in the hospital. | Other | Control group (SOC) |
Primary outcome
Anxiety
Time frame: State trait: 30 minutes pre operatively and 5 minutes post operatively. Anxiety using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
perioperative anxiety consisting of State, trait anxiety and anxiety experienced during the procedure. State anxiety: level of anxiety a person experiences in the current moment. Trait anxiety: Level of anxiety a person experiences in general, how anxious a person is in general. State and trait anxiety will be measured using the state trait anxiety inventory questionnaire consisting of 20 questions for state anxiety and 20 questions for trait anxiety. The questions are answered in the form of Likert scales ranging from 1 to 4. Anxiety experienced during the procedure will be measured using the visual analogue scale (VAS) which ranges from 0 (none) to 100 mm (worst imaginable).
Pain experienced during the procedure
Time frame: using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
The level of pain a patient experienced throughout the elective procedure measured using the Visual analogue scale (VAS) which ranges from 0 (none) to 100 mm (worst imaginable).
8 secondary outcomes
Procedural comfort
Time frame: 5 minutes after the procedure
Operator comfort (nurses and doctors).
Time frame: 5 minutes after the procedure.
Nausea
Time frame: 5 minutes after the procedure
Systolic blood pressure
Time frame: At the start of the procedure and every 15 minutes.
Diastolic blood pressure
Time frame: At the start of the procedure and every 15 minutes.
Mean Blood pressure
Time frame: At the start of the procedure and every 15 minutes.
Heart rate
Time frame: At the start of the procedure and every 15 minutes.
Satisfaction with VR (for patient, nurses and doctors)
Time frame: 5 minutes after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- 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.
Johan De Sutter, PHD, MD principal investigator
University Ghent
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 headset in people with Anxiety and Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 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 14 Dec 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 Belgium. 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?
Contact Karen VandenBussche, PHD (02 477 60 09, Karen.VandenBussche@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: State trait: 30 minutes pre operatively and 5 minutes post operatively. Anxiety using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.