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

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

Inclusion Criteria3

  • 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 Criteria5

  • 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

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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