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

Not Applicable

Completed

• Conditions: Stone Ureter; Stone, Kidney
• Interventions: Device: Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)

• Registration Number: NCT05183269
• Lead Sponsor: AZ Sint-Lucas Gent

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.

Detailed Description

The patients were randomized in two groups SWL with VR and SWL without VR. When a patient was randomized for a VR session we put on the monitor after adequate patient positioning. We used the Oncomfort Sedakit.

The size and location of stone pre-treatment was measured based on the best available imaging tool (CT\>RX/ultrasonography) using the maximal stone diameter. The locations of the stones were described as upper pole stones, midpolar stones, lower pole stones, renal pelvis stones and proximal ureteric stones. Each SWL treatment was standardized using diclofenac 100 mg suppository as analgesic and local lidocain/prilocain cream (EMLA 5g, Aspen) to numb the skin. Visualization of the stone was done by fluoroscopy of ultrasonography, as these proved to be equivalent (Van Besien et al. 2017).

A specific and standardized ramping protocol was applied. After finishing this protocol, the energy level could be raised further depending on the level of discomfort of the patient.

Directly after the procedure, the patients were asked to complete a questionnaire where they were asked to write down the experienced amount of pain during the procedure on a VAS of 10 cm and the satisfaction level using a Likert-scale. The total delivered energy was noted.

Two weeks after every SWL session, follow-up imaging (ultrasound and plain abdominal radiography) was performed by a radiologist. Residual stone size was estimated on plain abdominal radiography or ultrasonography. The radiologist was blinded for the randomization process. Practitioner and patient were not. After each SWL the clinical outcome was noted.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2021-09-13
• Study Completion: 2021-09-13
• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality	Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)	Normal procedure with the use of a virtual reality monitor

Primary Outcome Measures

Name	Time	Method
Pain levels	right after the procedure	Pain levels determined by a VAS-score

Secondary Outcome Measures

Name	Time	Method
Satisfaction levels	right after the procedure	Satisfaction levels determined by a LIKERT-scale
Clinical success	2 weeks after the procedure	We defined clinical success as stone-free patients or patients with asymptomatic residual fragments ≤ 4 mm after 1 or more ESWL-sessions
Total delivered energy	right after the procedure	The total delivered energy during the shock-wave lithotripsy

Trial Locations

Locations (1)

AZ Sint-Lucas; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium