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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stone, Kidney, Stone Ureter

Intervention / Treatment
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* Device: Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>Normal procedure with the use of a virtual reality monitor | Device: Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)<br>* Use of the Oncomfort virtual reality monitor<br>|
| No Intervention: no virtual reality<br>Normal procedure without the use of a virtual reality monitor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain levels | Pain levels determined by a VAS-score | right after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction levels | Satisfaction levels determined by a LIKERT-scale | right after the procedure | 
| Total delivered energy | The total delivered energy during the shock-wave lithotripsy | right after the procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Shock-wave Lithotripsy, Pain control