Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Ghent | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (SOC) | Other | Standard of care |
|
| Intervention Group (VR) | Experimental | Standard of care with addition of the Virtual reality headset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Johan De Sutter, PHD, MD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | Jette | 1090 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Two group design, Standard of care (control) vs Standard of care + VR intervention (Intervention group)
Not provided
Not provided
Due to the visual presence of the VR, masking is not feasible.
Not provided
| Standard of care | Other | Elective procedure performed as planned according to current standard of care in the hospital. |
|
| 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:
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 |