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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05183269
Enrollment
166
Registered
2022-01-10
Start date
2019-10-01
Completion date
2021-09-13
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stone, Kidney, Stone Ureter

Keywords

Virtual Reality, Shock-wave Lithotripsy, Pain control

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.

Interventions

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

Use of the Oncomfort virtual reality monitor

Sponsors

AZ Sint-Lucas Gent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain levelsright after the procedurePain levels determined by a VAS-score

Secondary

MeasureTime frameDescription
Satisfaction levelsright after the procedureSatisfaction levels determined by a LIKERT-scale
Total delivered energyright after the procedureThe total delivered energy during the shock-wave lithotripsy
Clinical success2 weeks after the procedureWe defined clinical success as stone-free patients or patients with asymptomatic residual fragments ≤ 4 mm after 1 or more ESWL-sessions

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026