Virtual Sedation During Elective Procedures in the Cathlab

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Anxiety; Pain

Treatments: Device: Virtual reality headset; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06171620

22283VR Cathlab

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Control group (SOC)

Other group

Description:

Standard of care

Treatment:

Other: Standard of care

Intervention Group (VR)

Experimental group

Description:

Standard of care with addition of the Virtual reality headset

Treatment:

Device: Virtual reality headset