Virtual Sedation During Elective Procedures in the Cathlab

Pain Clinical Trial

Official title:

Virtual Reality as a Non-pharmacological Tool for Pain and Anxiety Relief During Elective Procedures in the Cathlab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171620
• Other study ID #: 22283VR Cathlab
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: August 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Karen VandenBussche, PHD
• Phone: 02 477 60 09
• Email: Karen.VandenBussche[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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.

Other:
• Standard of care
Elective procedure performed as planned according to current standard of care in the hospital.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels	Jette

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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