Paediatric Peri-operative Anxiety: Does the Little Journey App Help?
NCT ID: NCT03797716
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
596 participants
INTERVENTIONAL
2019-09-09
2024-06-30
Brief Summary
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Detailed Description
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Participants are pre-screened virtually through assessment of those placed on a waiting list for day case surgery at participating sites. Due to the Covid-19 pandemic, preoperative assessment clinic appointments for children undergoing ambulatory surgery have in general, moved from face-to-face appointments to telephone consultations. To enable consent and enrolment of suitable participants undergoing either telephone or face-to-face preoperative assessment, two consent pathways were developed:
Pathway 1: Remote consent. Participants are pre-screened virtually through assessment of those placed on a waiting list for day case surgery at participating sites. Pre-screening is based on the age of the child, and contingent on there being a minimum of 9 days between telephone consent and the day of planned surgery. This window has been developed to provide a minimum of 5 days of potential use time for the Little Journey app (allowing 2-3 days for the headset to arrive with the participant).
All eligible participants' parents/carers are sent a participation information sheet at least 48 hours before being approached for consent, and a copy of the consent form, by email or post. Children are also sent an information leaflet tailored to their age. A minimum of 3 working days will be provided to the parent / carer, between the research team sending them the PIS and subsequently being approached for telephone consent. Telephone consent follows a pre-approved script with opportunity provided for the parent/carer to ask questions. Families are provided with a copy of the consent form to refer to during the conversation. Telephone consent is documented on stage one of the consent form and placed in the patient notes. Written confirmation of consent (stage 2 of the consent form) is sought when the patient and carer come to hospital for surgery and before the time of transfer from the ward/outpatient are to the operating department. A copy of the signed consent form is provided to the participant's parent/carer and in the clinical notes; the original is retained in the investigator site file.
If available, at the time of consent, an assent form will be completed for children aged between 8 and 12 years of age.
Pathway 2: Face-to-face consent. Participants are pre-screened at the time of adding to a waiting list for a preoperative assessment clinic (PAC) appointment. Again, pre-screening will be based on the age of the child. All eligible participants' parents/carers are sent a PIS by email or post at least 3 working days before the planned PAC appointment. Children are also sent an information leaflet tailored to their age. Parents/carers may also be telephoned by a member of the research team informing them that the study is taking place, signposting them to the PIS, and informing them that a member of the research team will be at the PAC hoping to speak to them to offer the opportunity to take part in the trial.
At the PAC, children and their carers will undergo the standard evaluation and explanation of surgery and anaesthesia by a healthcare professional. This healthcare professional will ask if the parent/child are willing to speak with a member of the research team about the trial. If agreed, a member of the research team will then approach the parents/carers and children with a verbal explanation for the research and give them an opportunity to gain further information. If the parents/carers are content with the information provided, they will be asked to provide written consent for them and their child to be entered in the trial
Intervention 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.
Outcome Children's anxiety will be assessed at multiple time points along the surgical journey, ranging from the preoperative assessment clinic (if occurring), 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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. Both child and parent able to speak / understand one of the languages available on the app
5. American Society of Anesthesiologists' 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
Note: Surgery is defined as any procedure occurring in a theatre under the care of a surgeon or dentist and an anaesthetist.
Exclusion Criteria
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. Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
5. Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.
6. 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.
3 Years
12 Years
ALL
Yes
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University College, London
OTHER
Responsible Party
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Principal Investigators
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Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD
Role: STUDY_CHAIR
University College, London
Locations
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Barnet Hospital
Barnet, , United Kingdom
Royal United Hospital Bath
Bath, , United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
University Hospitals Bristol and Weston NHS Trust
Bristol, , United Kingdom
Mid Essex Hospital (Broomfield Hospital)
Chelmsford, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Glasgow Children's Hospital
Glasgow, , United Kingdom
Princess Alexandra Hospital
Harlow, , United Kingdom
Leeds Children's hospital
Leeds, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Royal London Hospital Bart's Health
London, , United Kingdom
University College London Hospitals
London, , United Kingdom
Whipps Cross Hospital Bart's Health
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
University Hospitals Plymouth
Plymouth, , United Kingdom
University Hospitals Southampton
Southampton, , United Kingdom
Torbay & South Devon
Torquay, , United Kingdom
Countries
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References
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Evans C, Bercades G, Ambler G, Wilson M, Brew-Graves C, Baldini C, Begum-Ali N, Williams NR, Emberton M, Fenton M, Fancourt D, Samani M, Mythen M, Moonesinghe SR. Little Journey: a phase III randomised controlled trial of a psychological preparation and education smartphone application for management of paediatric perioperative anxiety compared with standard care in children undergoing ambulatory surgery - study protocol. BMJ Open. 2025 Feb 26;15(2):e090696. doi: 10.1136/bmjopen-2024-090696.
Other Identifiers
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18/0197
Identifier Type: -
Identifier Source: org_study_id