Fact CheckerSign in

NCT03797716Completed

Paediatric Peri-operative Anxiety: Does the Little Journey App Help?

A Multi-site Randomised Controlled Trial Assessing the Effectiveness of the Little Journey App at Reducing Peri-operative Anxiety Compared to Standard Care.

Source: ClinicalTrials.gov · Last updated 24 Dec 2024

Brief summary (registry, in English)

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 ambulatory surgery compared to standard care.

Status (registry)
Completed
Study type
Interventional
Enrollment
596 (actual)
First submitted
23 Nov 2018
Start date
9 Sept 2019
Primary completion date
31 Mar 2024
Lead sponsor
University College, London
NCT number
NCT03797716

What you commit to

  • Study type: Interventional
  • Participants enrolled: 596
  • From 9 Sept 2019 to the primary completion date, 31 Mar 2024
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
  • 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.

Age

  • Children aged less than 3 years of age or more than 12 years' old on the date of parental consent

Other

  • 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
  • Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.

Who the study is looking for

  • 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.

Age in the registry: 3 years to 12 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Barnet Hospital
Coordinator of this site? Confirm its status
BarnetUnited KingdomUnknown status
Royal United Hospital Bath
Coordinator of this site? Confirm its status
BathUnited KingdomUnknown status
Brighton and Sussex University Hospitals NHS Trust
Coordinator of this site? Confirm its status
BrightonUnited KingdomUnknown status
University Hospitals Bristol and Weston NHS Trust
Coordinator of this site? Confirm its status
BristolUnited KingdomUnknown status
Mid Essex Hospital (Broomfield Hospital)
Coordinator of this site? Confirm its status
ChelmsfordUnited KingdomUnknown status
Medway Maritime Hospital
Coordinator of this site? Confirm its status
GillinghamUnited KingdomUnknown status
Glasgow Children's Hospital
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
HarlowUnited KingdomUnknown status
Leeds Children's hospital
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status
Royal Free Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
University College London Hospitals
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Royal London Hospital Bart's Health
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Whipps Cross Hospital Bart's Health
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Royal Manchester Children's Hospital
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
University Hospitals Plymouth
Coordinator of this site? Confirm its status
PlymouthUnited KingdomUnknown status
University Hospitals Southampton
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
Torbay & South Devon
Coordinator of this site? Confirm its status
TorquayUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.