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

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

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Psychological Distress; Children, Only; Anxiety Acute; Anxiety Fear; Peri-operative
• Intervention / Treatment: Device: Little Journey app

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher R Evans, MBBS; Phone Number: 02076799280; Email: situ.littlejourney@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
5. Both child and parent able to speak / understand one of the languages available on the Little Journey app (to be confirmed)

Note: Surgery is defined as any procedure occurring in a theatre under the care of a surgeon or dentist and an anaesthetist.

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
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.

Note: Children undergoing diagnostic procedures (e.g. MRI, Cardiac catheterisation) will not be included due to diagnostic uncertainty.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care arm; Participants will receive standard of care from the pre-assessment clinic until discharge. A typical preparatory National Health Service pathway would include: meeting a specialist nurse in the preoperative assessment clinic; a preoperative anaesthetic and surgical consultation; interaction with health play specialists on the day of surgery; and distraction interventions such as hand-held tablets during induction of anaesthesia. Participants may have inhalation or intravenous induction depending on the primary management plan of the anaesthetist in charge. Participants in the standard care arm will also receive a virtual reality cardboard headset, which can be taken home, personalised and decorated before use with virtual reality apps available to download from the app stores.
Experimental: Intervention arm; Participants allocated to the intervention arm will receive the same peri-operative management as the standard care arm and will also receive an access code enabling them to use the Little Journey app in the weeks leading up to their operation. We suggest the Little Journey app is used in the days to weeks leading up to the child's operation depending on their age. On downloading the app, if parents/carers insert the age of the child and date of surgery into the Little Journey app they will be sent a push notifications reminding them when to use it according to their child's age. However, it can be used as frequently as the child and/or their parents or carers wish before the operation.	Device: Little Journey app; The Little Journey app allows children to explore 360-degree hospital environments familiarising and desensitising them to areas and staff they'll see on the day of surgery. Children can "visit" the day case ward, anaesthetic and recovery rooms where their operation will occur -all while feeling safe in their own home. As the child explores the three areas, they are introduced to animated characters of staff who explain what will happen, the equipment that will be used and how they might feel. Using head tracking technology, the child triggers the animated characters by looking at them; meaning they control the pace of learning and speed at which they progress. The preparatory tool follows a pre-set story-line reflecting what happens from admission to discharge on the day of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Yale Pre Operative Anxiety score (shortened form)	An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety.	Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Yale Pre Operative Anxiety score (shortened form)	An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety.	Two weeks to six months before surgery: mYPAS-SF measured pre-randomisation in the Pre-Assessment clinic occurring a minimum of two-weeks before surgery, up to six-months before surgery depending on the participating research site.
Parent anxiety levels	A 100mm visual analogue scale assessing the current anxiety levels of parents (VAS-PA) about their child's surgery. The VAS-PA is a rapid method of assessing self-reported anxiety levels of parents before surgery. Self reported scores range from 0-100mm with higher scores signifying greater anxiety.	Two-weeks to six-months before surgery: Measured pre-randomisation in the pre-assessment clinic occurring a minimum of two-weeks before surgery, up to six-months before surgery date depending on the participating research site.
Modified Yale Pre Operative Anxiety score (shortened form)	An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety.	Day of Surgery (Day 1): Measured on the ward prior to surgery
Parent satisfaction with pre-operative information	A 100mm visual analogue scale assessing parents' satisfaction with the pre-operative information. This parent-reported score ranges from 0-100mm with higher scores signifying higher levels of satisfaction.	Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.
Child compliance in the anaesthetic room	A 100mm visual analogue scale assessing the child's compliance during the induction of anaesthesia completed by the independent observer following observation of the induction of anaesthesia. This independent observer reported score ranges from 0-100mm with higher scores signifying higher levels of compliance.	Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
Child distress in the anaesthetic room	A 100mm visual analogue scale assessing the child's level of distress during the induction of anaesthesia completed by the independent observer following observation of the induction of anaesthesia. This independent observer reported score ranges from 0-100mm with higher scores signifying higher levels of distress during the induction.	Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
Parent anxiety levels	A 100mm visual analogue scale assessing the current anxiety levels of parents (VAS-PA) about their child's surgery. The VAS-PA is a rapid method of assessing self-reported anxiety levels of parents before surgery. Self reported scores range from 0-100mm with higher scores signifying greater anxiety.	Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.
Time to induction of anaesthesia	The time taken for the induction of anaesthesia (minutes)	Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.
Incidence of the need for premedication	Number of patients given premedication prior to the induction of anaesthesia as per the prescription of the anaesthetist.	Day of surgery (Day 1): As recorded in the anaesthetic room
Analgesia and anti-emetic use in the recovery room.	As directed by the trial arm blinded clinical team based on their perceptions of child's symptoms in the recovery room.	Day of surgery (Day 1): Recorded in the recovery room following surgery
Time to recovery readiness	The time taken for participant to be ready for discharge back to the ward from the recovery room (minutes) as deemed by the recovery room nursing staff.	Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.
Parent satisfaction with care	A 100mm visual analogue scale assessing parents' satisfaction with the care they received on the day of surgery. This parent-reported score ranges from 0-100mm with higher scores signifying higher levels of satisfaction.	Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.
Time spent in hospital	The total time the participant spend in hospital from arrival on the ward to being discharged home (minutes).	Day of surgery (Day 1): Recorded at end of day of surgery following discharge.
Virtual reality headset side effects	An assessment of the side effects of use of a virtual reality headset in both children and their parents assessed through a parent reported checkbox questionnaire.	Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital
Incidence of unplanned admissions to hospital following surgery	The number of participants requiring unplanned admission to hospital following surgery for any reason.	Day of surgery (Day 1): Recorded at end of day of surgery
Incidence of unplanned cancellations on the scheduled date of surgery.	The number of participants whose surgery is cancelled on the day of surgery for any reason.	Day of surgery (Day 1): Recorded on the day of surgery
Post Hospital Behavioural Questionnaire	A parent-completed eleven-point questionnaire assessing changes in their child's behaviour following surgery. Consisting of eleven items, each item is scored using a five-point Likert scale ranging from "much less than before" to " much more than before". Higher scores are suggestive of increased post hospital regressive behavioural changes.	Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
Social cost analysis (Parents/Guardian)	The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.	Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
Social cost analysis (Participants)	The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.	Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
Post Hospital Behavioural Questionnaire	A parent-completed eleven-point questionnaire assessing changes in their child's behaviour following surgery. Consisting of eleven items, each item is scored using a five-point Likert scale ranging from "much less than before" to " much more than before". Higher scores are suggestive of increased post hospital regressive behavioural changes.	Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Social cost analysis (Parents/Guardian)	The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.	Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Social cost analysis (Participants)	The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.	Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Study Chair: Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD, University College, London

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety, peri-operative, preparation, app
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 18/0197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No