Little Journey multi-centre randomised controlled trial
Research type
Research Study
Full title
A Multi-site randomised controlled trial assessing the effectiveness of the Little Journey app at reducing peri-operative anxiety compared to standard care.
IRAS ID
251219
Contact name
Ramani Moonesinghe
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN23410641
Clinicaltrials.gov Identifier
Z6364106/2018/11/20 , Data Protection Registration number
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
This is a phase III multi-centre randomised controlled trial assessing the effectiveness of the Little Journey app: a pre-hospital psychological preparation tool designed for children undergoing ambulatory surgery.
Children presenting to the Pre-assessment clinic before their operation will be screened for recruitment to the trial. Those meeting the inclusion criteria and none of the exclusion criteria will be recruited to participate in the trial before randomisation into either a standard practise arm or intervention arm.
Children assigned to the intervention arm will be provided with a virtual reality google cardboard headset and access code for the Little Journey app which they can use as many times as they wish before their operation. In comparison the standard care arm will receive a google cardboard virtual reality headset with suggestions of free virtual apps to use and standard pre-operative preparation – as defined by each participating site.
Children’s anxiety will be assessed at multiple time points along the surgical journey, ranging from the pre-assessment clinic, ward and finally in the anaesthetic room during the induction of anaesthesia. Secondary outcome measures such as parent anxiety levels, post-hospital behavioural changes, need for rescue analgesia and antiemetics in the recovery room will be recorded. Children’s anxiety score in those assigned to the intervention arm will be undergo a further analysis assessing the impact of frequency and timing of app use before surgery.
The time between recruitment to the trial and the date of surgery will vary according to each study site and procedure type, likely between two-weeks and six-months.REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0255
Date of REC Opinion
8 May 2019
REC opinion
Further Information Favourable Opinion