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

NCT ID: NCT05183269

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-09-13

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.

Conditions

Stone, Kidney; Stone Ureter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual reality

Normal procedure with the use of a virtual reality monitor

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Use of the Oncomfort virtual reality monitor

no virtual reality

Normal procedure without the use of a virtual reality monitor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Use of the Oncomfort virtual reality monitor

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AZ Sint-Lucas Gent

OTHER

Sponsor Role: lead

Responsible Party

Luc Merckx

docter

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 36680576 (View on PubMed)

Other Identifiers

2018-44

Identifier Type: -

Identifier Source: org_study_id