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.
1 other identifier
interventional
596
1 country
17
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 ambulatory surgery compared to standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2018
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedDecember 24, 2024
December 1, 2024
4.6 years
November 23, 2018
December 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety.
Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room
Secondary Outcomes (20)
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
Two weeks to six months before surgery: mYPAS-SF measured pre-randomisation in the Pre-Assessment clinic occurring a minimum of two-weeks before surgery, up to six-months before surgery depending on the participating research site.
VAS - Parent Anxiety (VAS-PA)
Two-weeks to six-months before surgery: Measured pre-randomisation in the pre-assessment clinic occurring between two-weeks to six-months before surgery date.
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
Day of Surgery (Day 1): Measured on the ward prior to surgery
VAS - Satisfaction with pre-operative information (VAS-SI)
Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.
VAS - Compliance
Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
- +15 more secondary outcomes
Study Arms (2)
Standard Care arm
NO INTERVENTIONParticipants will receive standard of care from the pre-assessment clinic until discharge. A typical preparatory National Health Service pathway would include: meeting a specialist nurse in the preoperative assessment clinic; a preoperative anaesthetic and surgical consultation; interaction with health play specialists on the day of surgery; and distraction interventions such as hand-held tablets during induction of anaesthesia. Participants may have inhalation or intravenous induction depending on the primary management plan of the anaesthetist in charge. Participants in the standard care arm will also receive a virtual reality cardboard headset, which can be taken home, personalised and decorated before use with virtual reality apps available to download from the app stores.
Intervention arm
EXPERIMENTALParticipants allocated to the intervention arm will receive the same peri-operative management as the standard care arm and will also receive an access code enabling them to use the Little Journey app in the weeks leading up to their operation. We suggest the Little Journey app is used in the days to weeks leading up to the child's operation depending on their age. On downloading the app, if parents/carers insert the age of the child and date of surgery into the Little Journey app they will be sent a push notifications reminding them when to use it according to their child's age. However, it can be used as frequently as the child and/or their parents or carers wish before the operation.
Interventions
The Little Journey app allows children to explore 360-degree hospital environments familiarising and desensitising them to areas and staff they'll see on the day of surgery. Children can "visit" the day case ward, anaesthetic and recovery rooms where their operation will occur -all while feeling safe in their own home. As the child explores the three areas, they are introduced to animated characters of staff who explain what will happen, the equipment that will be used and how they might feel. Using head tracking technology, the child triggers the animated characters by looking at them; meaning they control the pace of learning and speed at which they progress. The preparatory tool follows a pre-set story-line reflecting what happens from admission to discharge on the day of surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Barnet Hospital
Barnet, United Kingdom
Royal United Hospital Bath
Bath, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN25BE, United Kingdom
University Hospitals Bristol and Weston NHS Trust
Bristol, United Kingdom
Mid Essex Hospital (Broomfield Hospital)
Chelmsford, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Glasgow Children's Hospital
Glasgow, United Kingdom
Princess Alexandra Hospital
Harlow, United Kingdom
Leeds Children's hospital
Leeds, United Kingdom
Royal Free Hospital
London, United Kingdom
Royal London Hospital Bart's Health
London, United Kingdom
University College London Hospitals
London, United Kingdom
Whipps Cross Hospital Bart's Health
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
University Hospitals Plymouth
Plymouth, United Kingdom
University Hospitals Southampton
Southampton, United Kingdom
Torbay & South Devon
Torquay, United Kingdom
Related Publications (1)
Evans C, Bercades G, Ambler G, Wilson M, Brew-Graves C, Baldini C, Begum-Ali N, Williams NR, Emberton M, Fenton M, Fancourt D, Samani M, Mythen M, Moonesinghe SR. Little Journey: a phase III randomised controlled trial of a psychological preparation and education smartphone application for management of paediatric perioperative anxiety compared with standard care in children undergoing ambulatory surgery - study protocol. BMJ Open. 2025 Feb 26;15(2):e090696. doi: 10.1136/bmjopen-2024-090696.
PMID: 40010809DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD
University College, London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2018
First Posted
January 9, 2019
Study Start
September 9, 2019
Primary Completion
March 31, 2024
Study Completion
June 30, 2024
Last Updated
December 24, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share