Peri-operative anxiety Not Applicable
Conditions
Interventions
Little Journey is a multi-centre, assessor-blinded, two-armed, parallel-group, randomised controlled clinical trial of a virtual reality psychological preparation app in children aged 3-12 years old u
a preoperative anaesthetic and surgical consultation
interaction with play specialists on the day of surgery
and distraction interventions such as hand-held tablets during the induction of anaesthesia. Participants can undergo either an inhalation or intravenous induction depending on the primary management
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged between 3-12 years of age on the date of parental consent to participate in the trial 2. 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) 3. Requiring general anaesthetic (must be their first general anaesthetic) 4. American Society of Anesthetists 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 5. Both child and parent able to speak/understand one of the languages available on the app (these languages are: English, Polish, Urdu, Arabic, Bengali)
Exclusion criteria
Exclusion criteria: 1. Children aged less than 3 years of age or more than 12 years’ old on the date of parental consent 2. Any child and/or parent that refuses to be part of the study 3. Patients and parents who do not speak one of the languages which are available on the app 4. 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 5. Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation) 6. Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child's anxiety levels measured using modified Yale Paediatric Anxiety Scale – Short form (m-YPAS-SF) at baseline at the pre-assessment clinic (timepoint 1), the ward (timepoint 2) and the anaesthetic room (timepoint 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parent satisfaction with information, measured using a 100 mm Visual Analogue Scale (VAS-IS) on the morning of surgery at timepoint 2 2. Parental anxiety levels measured using Visual Analogue Scale - parent anxiety (VAS-PA) at the pre-assessment clinic (timepoint 1) and immediately prior to observation of the induction of anaesthesia (timepoint 3) 3. Children’s compliance during induction, measured using a 100 mm Visual Analogue Scale - distress (VAS-D) by the independent observer immediately following observing the induction of anaesthesia (timepoint 3) 4. Children’s distress during induction, measured using a 100 mm Visual Analogue Scale - compliance (VAS-C) by the independent observer immediately following observing the induction of anaesthesia (timepoint 3) 5. Parental satisfaction measured using a 100 mm Visual Analogue Scale (VAS-PS) performed by parents/carers at timepoint 5 6. Adverse psychological affects measured using Post-Hospital Behavioural Questionnaire (PHBQ-AS) via email and telephone consultation at 2 and 4 weeks after discharge (timepoint 6) 7. Number of days of work or school missed by the family after the operation due to any adverse behavioural effects, measured via email or telephone consultation at 2 weeks after surgery (timepoint 6) 8. The time taken (minutes) for the induction of anaesthesia, time spent in the recovery room and time to discharge, measured at timepoints 3, 4 and 5 9. Requirement for ward-based premedication to treat preoperative anxiety: the number of children who are given an anxiolytic premedication (name and dose) before anaesthesia, recorded at timepoint 3: anaesthetic room 10. Change in anaesthetic induction plan after child arrives in anaesthetic room: the number of children whose induction technique changes from the planned technique to the actual technique used. This can be from inhalation induction to Intravenous induction and vice versa, recorded at timepoint 3: anaesthetic room 11. Rates of failure to progress | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed