NCT03379922

Strategies to Maximise Patient Comfort During ESWL

A Randomised Control Trial of Strategies to Maximise Patient Comfort During Extracorporeal Shockwave Lithotripsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Cliodhna Browne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Extracorporeal shockwave lithotripsy is an outpatient treatment for patients with intrarenal calculi. Standard of care involves offering oral analgesia prior to commencing the treatment. Most patients do not take the offered analgesia after the initial treatment. It has been suggested that distraction techniques may be equivalent to oral analgesia in improving tolerability of extracorporeal shockwave lithotripsy treatment. The use of distraction techniques also removes the potential side effects of mediation administration.

Detailed description

The investigators are aiming to assess if distraction techniques help improve patient comfort while undergoing extracorporeal shockwave lithotripsy treatment for renal calculi. Improved tolerability of treatment would result in longer duration of time on the lithotripsy machine and may lead to better stone fragmentation. Outcomes will be completion of treatment and scores on the short form McGill pain questionnaire. Patients will be randomised into three groups. The randomisation will not be blinded as this is not possible within the design of the study. The first group will be given stress balls to squeeze during treatment and will also receive standard care (the offer of oral analgesia). The second group will be given headphones to listen to music during treatment and will also receive standard care. The third group will receive standard care. Prior to commencing extracorporeal shockwave lithotripsy, patients will be given the shortened Health Anxiety Inventory score to complete. Following lithotripsy treatment, patients will be given the short form McGill pain questionnaire to complete. The initial pilot study will aim to recruit sixty patients and further recruitment will take place on the basis of the outcomes of the pilot study. Inclusion criteria All patients over eighteen years old undergoing extracorporeal shockwave lithotripsy for the first time Exclusion criteria Patients not capable of giving informed consent Patients in whom extracorporeal shockwave lithotripsy is contraindicated

Conditions

• Nephrolithiasis

Interventions

Type	Name	Description
BEHAVIORAL	Stress balls	Squeezing stress balls while receiving ESWL treatment
BEHAVIORAL	Headphones	Listening to music while receiving ESWL treatment

Timeline

• Start date: 2017-03-27
• Primary completion: 2018-12-12
• Completion: 2018-12-12
• First posted: 2017-12-20
• Last updated: 2019-04-17

Locations

1 site across 1 country: Ireland