Study Results
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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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-03-27
2018-12-12
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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)
Stress balls
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.
Headphones
Listening to music while receiving ESWL treatment
Control
The control group will receive standard care (the offer of oral analgesia)
No interventions assigned to this group
Interventions
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Stress balls
Squeezing stress balls while receiving ESWL treatment
Headphones
Listening to music while receiving ESWL treatment
Eligibility Criteria
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Inclusion Criteria
* First ESWL treatment
Exclusion Criteria
* Patients unsuitable for ESWL
18 Years
ALL
Yes
Sponsors
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Cliodhna Browne
OTHER
Responsible Party
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Cliodhna Browne
Specialist Registrar
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
Countries
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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.
Other Identifiers
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UCHGESWL
Identifier Type: -
Identifier Source: org_study_id
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