Strategies to Maximise Patient Comfort During ESWL

NCT ID: NCT03379922

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2018-12-12

Brief Summary

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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

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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

Conditions

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Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Stress balls

Intervention Type BEHAVIORAL

Squeezing stress balls while receiving ESWL treatment

Headphones

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

Group Type EXPERIMENTAL

Headphones

Intervention Type BEHAVIORAL

Listening to music while receiving ESWL treatment

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stress balls

Squeezing stress balls while receiving ESWL treatment

Intervention Type BEHAVIORAL

Headphones

Listening to music while receiving ESWL treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Over 18 years old
* First ESWL treatment

Exclusion Criteria

* Patients not capable of giving informed consent
* Patients unsuitable for ESWL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliodhna Browne

OTHER

Sponsor Role lead

Responsible Party

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Cliodhna Browne

Specialist Registrar

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cliodhna Browne, MRCSI

Role: PRINCIPAL_INVESTIGATOR

University College Hospital Galway, Ireland

Locations

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University College Hospital Galway

Galway, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type DERIVED
PMID: 32771299 (View on PubMed)

Other Identifiers

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UCHGESWL

Identifier Type: -

Identifier Source: org_study_id

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