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Clinical Trial 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.


Clinical Trial Description

This is a phase III multi-centre randomised controlled trial evaluating the effectiveness of the Little Journey app: a pre-hospital psychological preparation tool designed for children undergoing ambulatory surgery.

Children presenting to the Preoperative assessment clinic before their operation will be screened for recruitment to the trial. Those meeting the inclusion criteria will be recruited to participate in the trial before randomisation into either a standard practice arm or intervention arm. Consent will be provided by parents / guardians and assent by children aged 7-12 years old.

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. They will also receive the standard pre-operative preparation and care as per the recruiting site. 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 and care - as defined by each participating site.

Children's anxiety will be assessed at multiple time points along the surgical journey, ranging from the preoperative 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 scores in those assigned to the intervention arm will undergo a further analysis assessing the impact of frequency and timing of Little Journey app use before surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03797716
Study type Interventional
Source University College, London
Contact Christopher R Evans, MBBS
Phone 02076799280
Email situ.littlejourney@ucl.ac.uk
Status Not yet recruiting
Phase N/A
Start date March 1, 2019
Completion date March 31, 2021

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