Strategies to Maximise Patient Comfort During ESWL

Nephrolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379922
• Other study ID #: UCHGESWL
• Status: Completed
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: December 12, 2018

Study information

• Verified date: April 2019
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• First ESWL treatment

Exclusion Criteria:

• Patients not capable of giving informed consent

• Patients unsuitable for ESWL

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis

Intervention

Behavioral:
• Stress balls
Squeezing stress balls while receiving ESWL treatment
• Headphones
Listening to music while receiving ESWL treatment

Locations

Country	Name	City	State
Ireland	University College Hospital Galway	Galway

Sponsors (1)

Lead Sponsor	Collaborator
Cliodhna Browne

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Patients will complete the short form McGill pain questionnaire, subdivided into 11 sensory descriptors, 4 affective descriptors and a visual analogue score. Sensory and affective descriptors are each rated as 0-3. Sensory minimum score 0/33 (no pain), maximum score 33/33 (maximum pain). Affective minimum score 0/12 (no pain), maximum score 12/12 (maximum pain). Visual analogue score 0 to 10 (0 being no pain and 10 being worst possible pain).	At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)
Secondary	Early cessation of lithotripsy treatment	Cessation of lithotripsy treatment before completion (3000 shocks over 40-60 minutes)	At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)