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Completed

NCT Number: NCT03379922

Strategies to Maximise Patient Comfort During ESWL

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.

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Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Hospital Galway

Galway, Ireland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years old
  • First ESWL treatment

Exclusion criteria

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

Treatment and study plan

Stress balls

Behavioral

Squeezing stress balls while receiving ESWL treatment

Headphones

Behavioral

Listening to music while receiving ESWL treatment

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cliodhna Browne

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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