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

NCT06616324 | Recruiting

• 1 other identifier: EMN-2024-06741
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety; Pain; Virtual Reality; Lithotripsy

Keywords

Virtual Reality; Pain; Anxiety; VR; ESWL; Extracorporeal Shock Wave Lithotripsy; Lithotripsy; Non-pharmacological

Outcome Measures

Primary Outcomes (1)

• Pain at energy level 900

  Data about the pain is registered at energy level 900 during the ESWL treatment for the intervention and the control group. The pain is measured by using the Numeric Rating Scale rating from 0-10. Zero is no pain at all and 10 is the worst imaginable pain. The outcome measure will be assessed during the patient ESWL treatment when the energy level of 900 is reached.

  The outcome measure will be assessed from the start of the patient's ESWL treatment until the end of the procedure, with an average treatment duration of approximately 45 minutes.

Secondary Outcomes (7)

• Patient Satisfaction

  The outcome measure will be assessed by the patient 1 hour or less after the ESWL treatment have ended.

• Adverse events

  The outcome measure will be noted during or less than 1 hour after the ESWL treatment is finished.

• Procedure duration

  Measurements will be recorded for each individual during the treatment approximately 45 minutes.

• Pre- and intraprocedural pain

  Measurements will be taken at the day for treatment for each individual. At arrival at preperations room and during the patients ESWL treatment approximately 2 hours time frame..

• Anxiety

  Measurements will be taken at the day for treatment for each individual. At arrival at preperations room and during the patients ESWL treatment approximately 2 hours time frame.

Study Arms (2)

Intervention

EXPERIMENTAL

Standard treatment with Virtual Reality headset and Active-Noise-Cancelling headphones

Device: Virtual Reality

Control Group

NO INTERVENTION

Standard treatment without VR headset and ANC-headphones

Interventions

Virtual Reality DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Urologisk Afdeling

Roskilde, 4000, Denmark

RECRUITING

Related Publications (10)

• Zhang L, Zhang X, Pu Y, Zhang Y, Fan J. Global, Regional, and National Burden of Urolithiasis from 1990 to 2019: A Systematic Analysis for the Global Burden of Disease Study 2019. Clin Epidemiol. 2022 Aug 15;14:971-983. doi: 10.2147/CLEP.S370591. eCollection 2022.

  PMID: 35996396 BACKGROUND

• Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis. Eur Urol. 2016 Mar;69(3):468-74. doi: 10.1016/j.eururo.2015.07.040. Epub 2015 Aug 28.

  PMID: 26318710 BACKGROUND

• Marsdin E, Noble JG, Reynard JM, Turney BW. Audiovisual distraction reduces pain perception during shockwave lithotripsy. J Endourol. 2012 May;26(5):531-4. doi: 10.1089/end.2011.0430. Epub 2012 Feb 8.

  PMID: 22098167 BACKGROUND

• Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.

  PMID: 24602425 BACKGROUND

• Yilmaz E, Ozcan S, Basar M, Basar H, Batislam E, Ferhat M. Music decreases anxiety and provides sedation in extracorporeal shock wave lithotripsy. Urology. 2003 Feb;61(2):282-6. doi: 10.1016/s0090-4295(02)02375-0.

  PMID: 12597931 BACKGROUND

• Nakahara H, Furuya S, Masuko T, Francis PR, Kinoshita H. Performing music can induce greater modulation of emotion-related psychophysiological responses than listening to music. Int J Psychophysiol. 2011 Sep;81(3):152-8. doi: 10.1016/j.ijpsycho.2011.06.003. Epub 2011 Jun 24.

  PMID: 21704661 BACKGROUND

• McCaffery M. Nursing approaches to nonpharmacological pain control. Int J Nurs Stud. 1990;27(1):1-5. doi: 10.1016/0020-7489(90)90018-e.

  PMID: 2179151 BACKGROUND

• Cakmak O, Cimen S, Tarhan H, Ekin RG, Akarken I, Ulker V, Celik O, Yucel C, Kisa E, Ergani B, Cetin T, Kozacioglu Z. Listening to music during shock wave lithotripsy decreases anxiety, pain, and dissatisfaction : A randomized controlled study. Wien Klin Wochenschr. 2017 Oct;129(19-20):687-691. doi: 10.1007/s00508-017-1212-0. Epub 2017 May 17.

  PMID: 28516381 BACKGROUND

• Wang Z, Feng D, Wei W. Impact of music on anxiety and pain control during extracorporeal shockwave lithotripsy: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Jan 29;100(4):e23684. doi: 10.1097/MD.0000000000023684.

  PMID: 33530169 BACKGROUND

• Weynants L, Chys B, D'hulst P, Merckx L, Van Besien J, Tailly T. Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study. World J Urol. 2023 Feb;41(2):589-594. doi: 10.1007/s00345-023-04280-8. Epub 2023 Jan 21.

  PMID: 36680576 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karsten L Lassen, PhD student

  Urologisk Afdeling, Region Sjælland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karsten L Lassen, PhD student

CONTACT

4526131350; karlas@regionsjaelland.dk

Nanna W Christiansen, Engineer

CONTACT

4540306799; nanchr@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the nature of VR, it is impossible to mask the patients and the healthcare providers administering the shockwave treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 27, 2024
• Study Start: October 24, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)