Strategies to Maximise Patient Comfort During ESWL

NCT03379922 | Completed

• 1 other identifier: UCHGESWL
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• 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).

  At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)

Secondary Outcomes (1)

• Early cessation of lithotripsy treatment

  At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)

Study Arms (3)

Stress balls

EXPERIMENTAL

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

Headphones

EXPERIMENTAL

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

Behavioral: Headphones

Control

NO INTERVENTION

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

Interventions

Stress balls BEHAVIORAL

Squeezing stress balls while receiving ESWL treatment

Stress balls

Headphones BEHAVIORAL

Listening to music while receiving ESWL treatment

Headphones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• First ESWL treatment

You may not qualify if:

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

Sponsors & Collaborators

• Cliodhna Browne: lead

Study Sites (1)

University College Hospital Galway

Galway, Galway, Ireland

Location

Related Publications (1)

• 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.

  PMID: 32771299 DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Cliodhna Browne, MRCSI

  University College Hospital Galway, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Registrar

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 20, 2017
• Study Start: March 27, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

IE (1)