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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Urologisk Afdeling
RECRUITING
Roskilde
Contact Information
Primary
Karsten L Lassen, PhD student
karlas@regionsjaelland.dk
4526131350
Backup
Nanna W Christiansen, Engineer
nanchr@regionsjaelland.dk
4540306799
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 72
Treatments
Experimental: Intervention
Standard treatment with Virtual Reality headset and Active-Noise-Cancelling headphones
No_intervention: Control Group
Standard treatment without VR headset and ANC-headphones
Related Therapeutic Areas
Sponsors
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov