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

Stone, Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183269
• Other study ID #: 2018-44
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 13, 2021

Study information

• Verified date: December 2021
• Source: AZ Sint-Lucas Gent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 13, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Stone Ureter
• Stone, Kidney

Intervention

Device:
• Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)
Use of the Oncomfort virtual reality monitor

Locations

Country	Name	City	State
Belgium	AZ Sint-Lucas	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Lucas Gent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain levels	Pain levels determined by a VAS-score	right after the procedure
Secondary	Satisfaction levels	Satisfaction levels determined by a LIKERT-scale	right after the procedure
Secondary	Total delivered energy	The total delivered energy during the shock-wave lithotripsy	right after the procedure
Secondary	Clinical success	We defined clinical success as stone-free patients or patients with asymptomatic residual fragments = 4 mm after 1 or more ESWL-sessions	2 weeks after the procedure