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ArticleBMJ open2025

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.

Christopher Evans, Georgia Bercades, Gareth Ambler, Matthew Wilson, Chris Brew-Graves, Cinzia Baldini, Nazma Begum-Ali, Norman R Williams, Mark Emberton, Matthew Fenton and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03797716 (A Multi-site Randomised Controlled Trial Assessing the Effectiveness of the Little Journey App at Reducing Peri-operative Anxiety Compared to Standard Care.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03797716 nacompletednot on this map

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

TypeinterventionalSponsorUniversity College, LondonRan2019 to 2024Enrolled596ConditionsAnxiety Acute, Anxiety Fear, Peri-operative, Psychological DistressArmsLittle Journey app
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Christopher EvansCentre for Perioperative Medicine, Research Department of Targeted Intervention, University College London, London, UK.
Georgia BercadesCritical and Perioperative Care Theme, NIHR University College London Hospitals Biomedical Research Centre, London, UK.
Gareth AmblerApplied Statistics, University College London, London, UK.
Matthew WilsonHealth Services Research, University of Sheffield, Sheffield, UK.
Chris Brew-GravesDivision of Surgery and Interventional Science, University College London, London, UK.
Cinzia BaldiniUniversity College London, London, UK.
Nazma Begum-AliSurgical Interventional Group, University College London, London, UK.
Norman R WilliamsDivision of Surgery and Interventional Science, University College London, London, UK.ORCID http://orcid.org/0000-0001-6496-312X
Mark EmbertonDivision of Surgery and Interventional Science, University College London, London, UK.ORCID http://orcid.org/0000-0003-4230-0338
Matthew FentonGreat Ormond Street Hospital for Children, London, UK.
Daisy FancourtDepartment of Behavioural Science and Health, Department of Epidemiology and Public Health, University College London Research, London, UK.ORCID http://orcid.org/0000-0002-6952-334X
Mohini SamaniNIHR CRN West Midlands Young Persons Steering Group, Stafford, UK.
Monty MythenAnaethesia, University College Hopital, London, UK.
Suneetha Ramani MoonesingheCentre for Perioperative Medicine, Research Department of Targeted Intervention, University College London, London, UK ramani.moonesinghe@nhs.net.ORCID http://orcid.org/0000-0002-6730-5824

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChildren having surgery, and their parents, commonly have anxiety in the preoperative period, and this may impact longer-term health and quality of life. Psychological preparation can be expensive and time-consuming, and the type and effectiveness of preparatory interventions are variable. The aim of this randomised controlled trial (RCT) is to evaluate the clinical effectiveness of a preoperative smartphone psychological preparation application with virtual reality (VR) capability (the 'Little Journey app' (LJ)), at reducing anxiety and its sequelae in children and their carers. METHODS AND ANALYSIS: Multicentre, assessor-blinded, two-armed, parallel group, RCT in children aged between 3 and 12 years, undergoing ambulatory surgery and receiving their first general anaesthetic. Randomisation is one-to-one between an intervention and a control arm. Participants in the intervention arm are provided with access to the LJ app and a low-cost cardboard VR headset (to be used with a smartphone) to use in the weeks leading up to their operation. Children in the control arm receive the same VR headset and suggestions of unrelated VR games to play, but no access to the LJ app. To improve accessibility, smart devices are provided to children whose families do not have a smart phone, and the app content has been translated from English into multiple languages. Both groups receive standard perioperative care at the hospital where they are having treatment. The primary outcome measure is the modified Yale Preoperative Anxiety Scale-Short Form applied by independent blinded observers, immediately before induction of general anaesthesia. Secondary outcomes include process measures, psychological and socioeconomic outcomes for both children and parents/carers. The planned sample size was 304 participants, including an anticipated 15% attrition rate. An interim analysis was conducted when the trial was temporarily paused because of the COVID-19 pandemic, at which point 119 participants had been recruited. The trial steering committee and data monitoring committee recommended continuation of the trial, but the sample size was increased to 596 to account for differences between the previously anticipated and actual outcomes of recruited participants. ETHICS AND DISSEMINATION: The study was approved by Surrey Borders-Research Ethics Committee 251219, and all participating sites were in England. Results will be presented in academic manuscripts and presentations and summarised for diverse audiences (including clinicians and patients/public) in podcasts, infographics and other multimedia formats. TRIAL REGISTRATION NUMBER: NCT03797716.

Indexed as

Ambulatory Surgical ProceduresAnxietyMobile ApplicationsPreoperative CareSmartphoneChildChild, PreschoolFemaleHumansMaleMulticenter Studies as TopicParentsRandomized Controlled Trials as TopicSingle-Blind MethodVirtual RealityAnxiety disordersPaediatric anaesthesiaPaediatric surgeryRandomized Controlled TrialVirtual Reality

Identifiers

PMID40010809
PMCPMC11865764

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.