NCT06171620

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2023-12-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: Belgium