Clinical trial NCT05183269: Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution
Official title: Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stone, Kidney
Stone Ureter
Keywords: Virtual Reality
Shock-wave Lithotripsy
Pain control
Lead sponsor: AZ Sint-Lucas Gent
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain levels
timeFrame: right after the procedure
Secondary outcomes:
measure: Satisfaction levels
timeFrame: right after the procedure
measure: Total delivered energy
timeFrame: right after the procedure
measure: Clinical success
timeFrame: 2 weeks after the procedure
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
state: Oost-Vlaanderen
Study officials:
References: