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Strategies to Maximise Patient Comfort During ESWL

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Stress balls
Headphones
Sponsored by
Cliodhna Browne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nephrolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Over 18 years old
  • First ESWL treatment

Exclusion Criteria:

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

Sites / Locations

  • University College Hospital Galway

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Stress balls

Headphones

Control

Arm 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)

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Early cessation of lithotripsy treatment
Cessation of lithotripsy treatment before completion (3000 shocks over 40-60 minutes)

Full Information

First Posted
December 12, 2017
Last Updated
April 16, 2019
Sponsor
Cliodhna Browne
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1. Study Identification

Unique Protocol Identification Number
NCT03379922
Brief Title
Strategies to Maximise Patient Comfort During ESWL
Official Title
A Randomised Control Trial of Strategies to Maximise Patient Comfort During Extracorporeal Shockwave Lithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cliodhna Browne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress balls
Arm Type
Experimental
Arm 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)
Arm Title
Headphones
Arm Type
Experimental
Arm Description
The second arm will be given headphones to listen to music during their treatment and will also receive standard care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive standard care (the offer of oral analgesia)
Intervention Type
Behavioral
Intervention Name(s)
Stress balls
Intervention Description
Squeezing stress balls while receiving ESWL treatment
Intervention Type
Behavioral
Intervention Name(s)
Headphones
Intervention Description
Listening to music while receiving ESWL treatment
Primary Outcome Measure Information:
Title
Pain score
Description
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).
Time Frame
At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)
Secondary Outcome Measure Information:
Title
Early cessation of lithotripsy treatment
Description
Cessation of lithotripsy treatment before completion (3000 shocks over 40-60 minutes)
Time Frame
At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 18 years old First ESWL treatment Exclusion Criteria: Patients not capable of giving informed consent Patients unsuitable for ESWL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cliodhna Browne, MRCSI
Organizational Affiliation
University College Hospital Galway, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital Galway
City
Galway
ZIP/Postal Code
Galway
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32771299
Citation
Browne C, Redmond E, Kelly T, Rogers E, O'Malley P, Nusrat N, Jaffry S, Durkan G, Walsh K, Dowling C, D'Arcy FT. Strategies to maximise patient comfort during extracorporeal shockwave lithotripsy - A randomised controlled trial. Surgeon. 2021 Aug;19(4):207-211. doi: 10.1016/j.surge.2020.07.002. Epub 2020 Aug 6.
Results Reference
derived

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Strategies to Maximise Patient Comfort During ESWL

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