Status:
COMPLETED
Paediatric Peri-operative Anxiety: Does the Little Journey App Help?
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Anxiety Acute
Anxiety Fear
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
To evaluate the clinical effectiveness of a virtual reality psychological preparation app at reducing peri-operative anxiety and its associated sequelae in children aged 3-12 years old undergoing ambu...
Detailed Description
This is a phase III multi-centre randomised controlled trial evaluating the effectiveness of the Little Journey app: a pre-hospital psychological preparation tool designed for children undergoing ambu...
Eligibility Criteria
Inclusion
- Children aged between 3-12 years of age on the date of parental consent to participate in the trial
- 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)
- Requiring general anaesthetic (must be their first general anaesthetic)
- Both child and parent able to speak / understand one of the languages available on the app
- American Society of Anesthesiologists' 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
- Note: Surgery is defined as any procedure occurring in a theatre under the care of a surgeon or dentist and an anaesthetist.
Exclusion
- Children aged less than 3 years of age or more than 12 years' old on the date of parental consent
- Any child and/or parent that refuses to be part of the study
- Patients and parents who do not speak one of the languages which are available on the app
- Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
- Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.
- 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.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT03797716
Start Date
September 9 2019
End Date
June 30 2024
Last Update
December 24 2024
Active Locations (17)
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1
Barnet Hospital
Barnet, United Kingdom
2
Royal United Hospital Bath
Bath, United Kingdom
3
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN25BE
4
University Hospitals Bristol and Weston NHS Trust
Bristol, United Kingdom