Clinical trial NCT03797716: Paediatric Peri-operative Anxiety: Does the Little Journey App Help?
Official title: A Multi-site Randomised Controlled Trial Assessing the Effectiveness of the Little Journey App at Reducing Peri-operative Anxiety Compared to Standard Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Acute
Anxiety Fear
Peri-operative
Psychological Distress
Surgery
Children, Only
Keywords: Anxiety, peri-operative, preparation, app
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-01-09
Enrollment: 596
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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.

Eligibility 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. 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:

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. 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.

Primary outcomes:
measure: Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
timeFrame: Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room
Secondary outcomes:
measure: Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
timeFrame: 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.
measure: VAS - Parent Anxiety (VAS-PA)
timeFrame: Two-weeks to six-months before surgery: Measured pre-randomisation in the pre-assessment clinic occurring between two-weeks to six-months before surgery date.
measure: Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
timeFrame: Day of Surgery (Day 1): Measured on the ward prior to surgery
measure: VAS - Satisfaction with pre-operative information (VAS-SI)
timeFrame: Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.
measure: VAS - Compliance
timeFrame: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
measure: VAS Distress
timeFrame: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
measure: VAS - Parent Anxiety (VAS-PA)
timeFrame: Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.
measure: Time to induction
timeFrame: Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.
measure: Analgesic use
timeFrame: Day of surgery (Day 1): Recorded in the recovery room following surgery
measure: Anti-emetic use
timeFrame: Day of surgery (Day 1): Recorded in the recovery room following surgery
measure: Time to recovery
timeFrame: Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.
measure: VAS- Parent satisfaction with care
timeFrame: Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.
measure: Time to discharge
timeFrame: Day of surgery (Day 1): Recorded at end of day of surgery following discharge.
measure: Unplanned cancellations
timeFrame: Day of surgery (Day 1): recorded prior to attempt of induction of anaesthesia
measure: Adverse events questionnaire
timeFrame: Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital
measure: Unplanned admissions
timeFrame: Day of surgery (Day 1): Recorded at end of day of surgery
measure: Post Hospital Behavioural Questionnaire
timeFrame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
measure: Number of days of work/school missed
timeFrame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
measure: Post Hospital Behavioural Questionnaire
timeFrame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
measure: Number of days of work/school missed
timeFrame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Other outcomes:
Locations:
city: Barnet
country: United Kingdom
facility: Barnet Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Trust
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital (Broomfield Hospital)
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Children's Hospital
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: Leeds
country: United Kingdom
facility: Leeds Children's hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Royal London Hospital Bart's Health
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Whipps Cross Hospital Bart's Health
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton
city: Torquay
country: United Kingdom
facility: Torbay & South Devon
Study officials:
affiliation: University College, London
name: Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD
role: STUDY_CHAIR
References: