Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Recruiting · NCT06616324 · Interventional (participants receive a specific treatment) · Lead sponsor: Zealand University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements. The primary outcome is pain at energy level 900 during ESWL for the intervention and the control group. The secondary outcomes are as follows: * Type and dose of analgesia * Conductance scores/values * Anxiety levels * Patient satisfaction * Procedure duration * Adverse events Participants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not
Who can take part
Inclusion criteria
- Scheduled for ESWL at Region Zealand
- Age of 18 or above
- Ability to understand the trial protocol, risks, and benefits and provide signed informed consent
Exclusion criteria
- Inability to read and understand Danish.
- Uncooperativeness (as judged by investigators)
- Claustrophobia or fear of small spaces
- Disorders that prevent the person from wearing a VR device
- Highly visually or auditive impaired
Where it is running
1 location listed.
- Urologisk Afdeling - Roskilde, Denmark