Virtual Sedation During Elective Procedures in the Cathlab
NCT ID: NCT06171620
Last Updated: 2023-12-14
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
64 participants
INTERVENTIONAL
2023-06-26
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group (SOC)
Standard of care
Standard of care
Elective procedure performed as planned according to current standard of care in the hospital.
Intervention Group (VR)
Standard of care with addition of the Virtual reality headset
Virtual reality headset
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual reality headset
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 care
Elective procedure performed as planned according to current standard of care in the hospital.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Agreeing to participate via signed informed consent.
* Being at least 18 years of age.
* Being fluent in either English, French or Dutch language.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Ghent
OTHER
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Johan De Sutter, PHD, MD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitair Ziekenhuis Brussel
Brussels, Jette, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Karen VandenBussche, PHD
Role: primary
Pieter-Jan Goossens, BS
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22283VR Cathlab
Identifier Type: -
Identifier Source: org_study_id