Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution

NCT05183269 | Completed

• 1 other identifier: 2018-44
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to prospectively analyze patient satisfaction, pain, delivered energy and clinical effectiveness of using VR as a complimentary treatment modality during SWL.

Conditions

Stone, Kidney; Stone Ureter

Keywords

Virtual Reality; Shock-wave Lithotripsy; Pain control

Outcome Measures

Primary Outcomes (1)

• Pain levels

  Pain levels determined by a VAS-score

  right after the procedure

Secondary Outcomes (3)

• Satisfaction levels

  right after the procedure

• Total delivered energy

  right after the procedure

• Clinical success

  2 weeks after the procedure

Study Arms (2)

Virtual reality

EXPERIMENTAL

Normal procedure with the use of a virtual reality monitor

Device: Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)

no virtual reality

NO INTERVENTION

Normal procedure without the use of a virtual reality monitor

Interventions

Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium) DEVICE

Use of the Oncomfort virtual reality monitor

Virtual reality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with renal or ureteric stones in need of a shock-wave lithotripsy. The indication was based on the European association of urology guidelines

You may not qualify if:

• none

Sponsors & Collaborators

• AZ Sint-Lucas Gent: lead

Study Sites (1)

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis; Agnosia

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: docter

Model Details: Control arm: diclofenac 100 mg suppository + local lidocain/prilocain cream (EMLA 5g, Aspen) Intervention arm: diclofenac 100 mg suppository + local lidocain/prilocain cream (EMLA 5g, Aspen) + Oncomfort virtual reality monitor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: October 1, 2019
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)