RecruitingNot ApplicableNCT06616324

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

Virtual Reality: An Innovative Approach to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy - A Randomized Controlled Trial

Sponsor

Zealand University Hospital

Enrollment

72 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

Pain Virtual Reality Anxiety Lithotripsy

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a virtual reality (VR) headset during extracorporeal shock wave lithotripsy (ESWL) — a non-invasive procedure that uses sound waves to break up kidney stones — reduces pain and anxiety. VR distraction therapy may offer a drug-free way to make the procedure more comfortable. **You may be eligible if...** - You are 18 years old or older - You are scheduled to have ESWL for kidney stones at Region Zealand (Denmark) - You are able to understand the study and provide signed consent **You may NOT be eligible if...** - You are unable to read or understand Danish - You are uncooperative or unable to participate in the assessments - You have claustrophobia or fear of enclosed spaces - You have a condition that prevents wearing a VR headset (e.g., certain eye or head conditions) - You have a history of epilepsy or seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual Reality

Participants in the intervention group will undergo ESWL according to standard treatment but with the addition of Virtual Reality and ANC-headphones as a supplement.

Locations(1)

Urologisk Afdeling

Roskilde, Denmark

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NCT06616324

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