Global, Regional, and National Burden of Urolithiasis from 1990 to 2019: A Systematic Analysis for the Global Burden of Disease Study 2019.
Lu Zhang, Xu Zhang, Yuanchun Pu...
https://pubmed.ncbi.nlm.nih.gov/35996396Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06616324
Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy A Randomized Controlled Trial
Led by Zealand University Hospital · Updated on 2025-09-23
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if using Virtual Reality (VR) during Extracorporeal Shock Wave Lithotripsy (ESWL), a treatment for kidney stones, can reduce patients' pain and anxiety. This study compares standard care with an added VR experience that aims to distract patients and potentially lower the need for pain medication. The trial also explores patients' views on how VR affects their experience during the procedure. Participants are randomly assigned to one of two groups. The intervention group will receive ESWL with a Virtual Reality headset and noise-cancelling headphones playing a chosen video during treatment, while the control group will have ESWL without VR or headphones. Both groups follow standard medication protocols, including premedication with paracetamol and ibuprofen and possible fentanyl during the procedure. The study does not require extra visits or prolong hospital stays. During the ESWL procedure, which lasts about 45 minutes, researchers measure pain levels, anxiety, analgesic use, patient satisfaction, procedure duration, and any adverse events. Pain is specifically assessed at the energy level 900 of the treatment. Anxiety and pain levels are recorded before and during the procedure. Patient feedback on satisfaction is collected within an hour after treatment. The study ensures blinded assessment and data analysis, lasting from screening to procedure completion without extended follow-up.
CONDITIONS
Brief Title
Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Scheduled for Extracorporeal Shock Wave Lithotripsy (ESWL) at Region Zealand
- Age 18 years or older
- Ability to understand the trial protocol, risks, and benefits and provide signed informed consent
You will not qualify if you...
- Unable to read and understand Danish
- Uncooperative behavior as judged by investigators
- Claustrophobia or fear of small spaces
- Conditions preventing wearing a Virtual Reality device
- Severe visual or hearing impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 45 minutes
Participants undergo Extracorporeal Shock Wave Lithotripsy (ESWL) with or without the addition of Virtual Reality and Active-Noise-Cancelling headphones to help reduce pain and anxiety during the procedure.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Urologisk Afdeling
Roskilde, Denmark, 4000
Actively Recruiting
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Research Team
K
Karsten L Lassen, PhD student
N
Nanna W Christiansen, Engineer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis.
Christian Türk, Aleš Petřík, Kemal Sarica...
https://pubmed.ncbi.nlm.nih.gov/26318710Audiovisual distraction reduces pain perception during shockwave lithotripsy.
Emma Marsdin, Jeremy G Noble, John M Reynard...
https://pubmed.ncbi.nlm.nih.gov/22098167The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure.
Esma Ozsaker, Alev Diramali
https://pubmed.ncbi.nlm.nih.gov/24602425Music decreases anxiety and provides sedation in extracorporeal shock wave lithotripsy.
Erdal Yilmaz, Saziye Ozcan, Murat Basar...
https://pubmed.ncbi.nlm.nih.gov/12597931Performing music can induce greater modulation of emotion-related psychophysiological responses than listening to music.
Hidehiro Nakahara, Shinichi Furuya, Tsutomu Masuko...
https://pubmed.ncbi.nlm.nih.gov/21704661Nursing approaches to nonpharmacological pain control.
M McCaffery
https://pubmed.ncbi.nlm.nih.gov/2179151Listening to music during shock wave lithotripsy decreases anxiety, pain, and dissatisfaction : A randomized controlled study.
Ozgur Cakmak, Sertac Cimen, Huseyin Tarhan...
https://pubmed.ncbi.nlm.nih.gov/28516381Impact of music on anxiety and pain control during extracorporeal shockwave lithotripsy: A protocol for systematic review and meta-analysis.
Zhenghao Wang, Dechao Feng, Wuran Wei
https://pubmed.ncbi.nlm.nih.gov/33530169Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study.
Laurens Weynants, Brecht Chys, Pieter D'hulst...
https://pubmed.ncbi.nlm.nih.gov/36680576