Clinical trial NCT06171620: Virtual Sedation During Elective Procedures in the Cathlab
Official title: Virtual Reality as a Non-pharmacological Tool for Pain and Anxiety Relief During Elective Procedures in the Cathlab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2023-12-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group design, Standard of care (control) vs Standard of care + VR intervention (Intervention group)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Anxiety
timeFrame: 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.
measure: Pain experienced during the procedure
timeFrame: using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
Secondary outcomes:
measure: Procedural comfort
timeFrame: 5 minutes after the procedure
measure: Operator comfort (nurses and doctors).
timeFrame: 5 minutes after the procedure.
measure: Nausea
timeFrame: 5 minutes after the procedure
measure: Systolic blood pressure
timeFrame: At the start of the procedure and every 15 minutes.
measure: Diastolic blood pressure
timeFrame: At the start of the procedure and every 15 minutes.
measure: Mean Blood pressure
timeFrame: At the start of the procedure and every 15 minutes.
measure: Heart rate
timeFrame: At the start of the procedure and every 15 minutes.
measure: Satisfaction with VR (for patient, nurses and doctors)
timeFrame: 5 minutes after the procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Jette
Study officials:
affiliation: University Ghent
name: Johan De Sutter, PHD, MD
role: PRINCIPAL_INVESTIGATOR
References: