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

RecruitingNAAges 18 Years - anyAllZealand University Hospital
NCT06616324 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 R

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📋 Eligibility rules (as published)
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
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What it tests

  • Virtual Reality
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Where

1 site
Urologisk Afdeling
Roskilde, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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