Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

Recruiting now · Not applicable

Conditions studied: Anxiety, Pain, Virtual Reality, Lithotripsy

In brief

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

Key facts

Study ID

NCT06616324

Run by

Zealand University Hospital

People needed

72

Starts

2024-10-24

Expected to finish

2025-10-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Urologisk Afdeling — Roskilde, Denmark (enrolling)

Full record on ClinicalTrials.gov

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