Virtual Sedation During Elective Procedures in the Cathlab

NCT06171620 | Unknown

• 1 other identifier: 22283VR Cathlab
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.

Secondary Outcomes (8)

• Procedural comfort

  5 minutes after the procedure

• Operator comfort (nurses and doctors).

  5 minutes after the procedure.

• Nausea

  5 minutes after the procedure

• Systolic blood pressure

  At the start of the procedure and every 15 minutes.

• Diastolic blood pressure

  At the start of the procedure and every 15 minutes.

Study Arms (2)

Control group (SOC)

OTHER

Standard of care

Other: Standard of care

Intervention Group (VR)

EXPERIMENTAL

Standard of care with addition of the Virtual reality headset

Device: Virtual reality headset

Interventions

Virtual reality headset DEVICE

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.

Intervention Group (VR)

Standard of care OTHER

Elective procedure performed as planned according to current standard of care in the hospital.

Control group (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• University Ghent: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Johan De Sutter, PHD, MD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen VandenBussche, PHD

CONTACT

02 477 60 09; Karen.VandenBussche@uzbrussel.be

Pieter-Jan Goossens, Student

CONTACT

02 477 60 09; Pieter-Jan.goossens@uzbrussel.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the visual presence of the VR, masking is not feasible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two group design, Standard of care (control) vs Standard of care + VR intervention (Intervention group)

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: December 14, 2023
• Study Start: June 26, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)