Surgery Clinical Trial - Paediatric Peri-operative Anxiety: Does

Status Not yet recruiting

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

Clinical Trial Details

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Paediatric Peri-operative Anxiety: Does the Little Journey App Help? — Little Journey

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms