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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barnet Hospital Coordinator of this site? Confirm its status | Barnet | United Kingdom | Unknown status |
| Royal United Hospital Bath Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| Brighton and Sussex University Hospitals NHS Trust Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| University Hospitals Bristol and Weston NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Mid Essex Hospital (Broomfield Hospital) Coordinator of this site? Confirm its status | Chelmsford | United Kingdom | Unknown status |
| Medway Maritime Hospital Coordinator of this site? Confirm its status | Gillingham | United Kingdom | Unknown status |
| Glasgow Children's Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Harlow | United Kingdom | Unknown status |
| Leeds Children's hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal London Hospital Bart's Health Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Whipps Cross Hospital Bart's Health Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Manchester Children's Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| University Hospitals Plymouth Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| University Hospitals Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Torbay & South Devon Coordinator of this site? Confirm its status | Torquay | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.