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Strategies to Maximise Patient Comfort During ESWL

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ClinicalTrials.gov Identifier: NCT03379922
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Cliodhna Browne, University College Hospital Galway

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Behavioral: Stress balls Behavioral: Headphones Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Control Trial of Strategies to Maximise Patient Comfort During Extracorporeal Shockwave Lithotripsy
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stress balls
The first arm will be given stress balls to squeeze during their treatment and will also receive standard care (the offer of oral analgesia)
 Behavioral: Stress balls
Squeezing stress balls while receiving ESWL treatment
Experimental: Headphones
The second arm will be given headphones to listen to music during their treatment and will also receive standard care.
 Behavioral: Headphones
Listening to music while receiving ESWL treatment
No Intervention: Control
The control group will receive standard care (the offer of oral analgesia)


Outcome Measures
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Primary Outcome Measures :
  1. Pain score [ Time Frame: At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes) ]
    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).


Secondary Outcome Measures :
  1. Early cessation of lithotripsy treatment [ Time Frame: At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes) ]
    Cessation of lithotripsy treatment before completion (3000 shocks over 40-60 minutes)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 18 years old
  • First ESWL treatment

Exclusion Criteria:

  • Patients not capable of giving informed consent
  • Patients unsuitable for ESWL
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379922


Locations
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Ireland
University College Hospital Galway
Galway, Ireland, Galway
Sponsors and Collaborators
Cliodhna Browne
Investigators
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Principal Investigator: Cliodhna Browne, MRCSI University College Hospital Galway, Ireland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cliodhna Browne, Specialist Registrar, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT03379922    
Other Study ID Numbers: UCHGESWL
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
 Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical