Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06616324

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

Led by Zealand University Hospital · Updated on 2025-09-23

72

Participants Needed

1

Research Sites

48 weeks

Total Duration

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AI-Summary

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Urologisk Afdeling

Roskilde, Denmark, 4000

Actively Recruiting

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Research Team

K

Karsten L Lassen, PhD student

CONTACT

N

Nanna W Christiansen, Engineer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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