Strategies to Maximise Patient Comfort During ESWL

Cliodhna Browne

Status: Completed

Conditions: Nephrolithiasis

Treatments: Behavioral: Headphones; Behavioral: Stress balls

Study type: Interventional

Funder types: Other

Identifiers

NCT03379922

UCHGESWL

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 years old
• First ESWL treatment

Exclusion criteria

• Patients not capable of giving informed consent
• Patients unsuitable for ESWL

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Stress balls

Experimental group

Description:

The first arm will be given stress balls to squeeze during their treatment and will also receive standard care (the offer of oral analgesia)

Treatment:

Behavioral: Stress balls

Headphones

Experimental group

Description:

The second arm will be given headphones to listen to music during their treatment and will also receive standard care.

Treatment:

Behavioral: Headphones

Control

No Intervention group

Description:

The control group will receive standard care (the offer of oral analgesia)