Virtual Sedation During Elective Procedures in the Cathlab

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.

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 Overview

• Status: Recruiting
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: Standard of care; Device: Virtual reality headset

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen VandenBussche, PHD; Phone Number: 02 477 60 09; Email: Karen.VanDenBussche@UZBrussel.be
• Study Contact Backup: Name: Pieter-Jan Goossens, Student; Phone Number: 02 477 60 09; Email: Pieter-Jan.goossens@uzbrussel.com

Study Locations

• Belgium
  • Jette
    • Brussels, Jette, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Karen VandenBussche, PHD; Phone Number: 02 477 60 09; Email: Karen.VanDenBussche@UZBrussel.be
      • Contact: Pieter-Jan Goossens, BS; Phone Number: 02 477 60 09; Email: PieterJan.Goossens@UGent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group (SOC); Standard of care	Other: Standard of care; Elective procedure performed as planned according to current standard of care in the hospital.
Experimental: Intervention Group (VR); Standard of care with addition of the Virtual reality headset	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	5 minutes after the procedure

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: University Ghent
• Investigators: Principal Investigator: Johan De Sutter, PHD, MD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 22283VR Cathlab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No