Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution
Primary Purpose
Stone, Kidney, Stone Ureter
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)
Sponsored by
About this trial
This is an interventional treatment trial for Stone, Kidney focused on measuring Virtual Reality, Shock-wave Lithotripsy, Pain control
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
Sites / Locations
- AZ Sint-Lucas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality
no virtual reality
Arm Description
Normal procedure with the use of a virtual reality monitor
Normal procedure without the use of a virtual reality monitor
Outcomes
Primary Outcome Measures
Pain levels
Pain levels determined by a VAS-score
Secondary Outcome Measures
Satisfaction levels
Satisfaction levels determined by a LIKERT-scale
Total delivered energy
The total delivered energy during the shock-wave lithotripsy
Clinical success
We defined clinical success as stone-free patients or patients with asymptomatic residual fragments ≤ 4 mm after 1 or more ESWL-sessions
Full Information
NCT ID
NCT05183269
First Posted
December 21, 2021
Last Updated
December 21, 2021
Sponsor
AZ Sint-Lucas Gent
1. Study Identification
Unique Protocol Identification Number
NCT05183269
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Lucas Gent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney, Stone Ureter
Keywords
Virtual Reality, Shock-wave Lithotripsy, Pain control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Normal procedure with the use of a virtual reality monitor
Arm Title
no virtual reality
Arm Type
No Intervention
Arm Description
Normal procedure without the use of a virtual reality monitor
Intervention Type
Device
Intervention Name(s)
Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)
Intervention Description
Use of the Oncomfort virtual reality monitor
Primary Outcome Measure Information:
Title
Pain levels
Description
Pain levels determined by a VAS-score
Time Frame
right after the procedure
Secondary Outcome Measure Information:
Title
Satisfaction levels
Description
Satisfaction levels determined by a LIKERT-scale
Time Frame
right after the procedure
Title
Total delivered energy
Description
The total delivered energy during the shock-wave lithotripsy
Time Frame
right after the procedure
Title
Clinical success
Description
We defined clinical success as stone-free patients or patients with asymptomatic residual fragments ≤ 4 mm after 1 or more ESWL-sessions
Time Frame
2 weeks after the procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
AZ Sint-Lucas
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution
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