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

NCT06616324 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-23

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Virtual 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.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Karsten L Lassen, PhD student · Urologisk Afdeling, Region Sjælland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616324 on ClinicalTrials.gov