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Clinical Trials/ISRCTN23410641
ISRCTN23410641
Completed
未知

A multi-site randomised controlled trial assessing the effectiveness of the Little Journey app at reducing peri-operative anxiety compared to standard care

niversity College London0 sites304 target enrollmentStarted: February 28, 2020Last updated:
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Overview

Phase
未知
Status
Completed
Sponsor
niversity College London
Enrollment
304
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1\. Children aged between 3\-12 years of age on the date of parental consent to participate in the trial
  • •2\. Those undergoing surgery planned to be conducted as a day\-case (surgery is defined as any therapeutic procedure taking place under the care of an anaesthetist and surgeon or dentist)
  • •3\. Requiring general anaesthetic (must be their first general anaesthetic)
  • •4\. American Society of Anesthetists physical status class I\-III
  • •Class I: A normal healthy patient
  • •Class II: A patient with mild systemic disease
  • •Class III: A patient with severe systemic disease
  • •5\. Both child and parent able to speak/understand one of the languages available on the app (these languages are: English, Polish, Urdu, Arabic, Bengali)

Exclusion Criteria

  • •1\. Children aged less than 3 years of age or more than 12 years’ old on the date of parental consent
  • •2\. Any child and/or parent that refuses to be part of the study
  • •3\. Patients and parents who do not speak one of the languages which are available on the app
  • •4\. American Society of Anesthetists physical status class IV\-VI
  • •Class IV: A patient with severe systemic disease that is a constant threat to life
  • •Class V: A moribund patient who is not expected to survive without the operation
  • •5\. Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
  • •6\. Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case\-by\-case basis

Investigators

Sponsor
niversity College London

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