Anxiety AcuteNCT03797716
Paediatric Peri-operative Anxiety: Does the Little Journey App Help?
A study testing Little Journey app in people with Anxiety Acute and Anxiety Fear, run by University College, London at 17 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Acute, Anxiety Fear, Peri-operative
- What is being tested?
- Little Journey app
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 9 Sep 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3-12 years of age on the date of parental consent to participate in the trial
- 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)
- Requiring general anaesthetic (must be their first general anaesthetic)
- Both child and parent able to speak / understand one of the languages available on the app
- American Society of Anesthesiologists' physical status class I-III
- Class I: A normal healthy patient
Show all 9Show fewer
- 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.
Who cannot join
- Children aged less than 3 years of age or more than 12 years' old on the date of parental consent
- Any child and/or parent that refuses to be part of the study
- Patients and parents who do not speak one of the languages which are available on the app
- Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
- Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Barnet Hospital
Barnet
Royal United Hospital Bath
Bath
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN25BE
University Hospitals Bristol and Weston NHS Trust
Bristol
Mid Essex Hospital (Broomfield Hospital)
Chelmsford
Medway Maritime Hospital
Gillingham
Glasgow Children's Hospital
Glasgow
Princess Alexandra Hospital
Harlow
Leeds Children's hospital
Leeds
Royal Free Hospital
London
Royal London Hospital Bart's Health
London
University College London Hospitals
London
Whipps Cross Hospital Bart's Health
London
Royal Manchester Children's Hospital
Manchester
University Hospitals Plymouth
Plymouth
University Hospitals Southampton
Southampton
Torbay & South Devon
Torquay
About this study
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.
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.
Read the 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.
- Conditions
- Anxiety Acute, Anxiety Fear, Peri-operative, Psychological Distress, Surgery, Children, Only
- Being tested
- Little Journey app
- Keywords
- Anxiety, peri-operative, preparation, app
- Medical subject headings
- Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Little Journey appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care arm | No intervention | 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. |
| Intervention arm | Experimental | 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. Receives: Device: Little Journey app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
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.
Measured: Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room
Secondary outcomes (20)
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
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.
This only occurs if recruited through the Pre-Assessment clinic route.
Measured: 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.
VAS - Parent Anxiety (VAS-PA)
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. This only occurs if recruited through the Pre-Assessment clinic route.
Measured: 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.
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
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.
Measured: Day of Surgery (Day 1): Measured on the ward prior to surgery
VAS - Satisfaction with pre-operative information (VAS-SI)
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.
Measured: Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.
VAS - Compliance
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.
Measured: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
VAS Distress
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.
Measured: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
VAS - Parent Anxiety (VAS-PA)
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.
Measured: Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.
Time to induction
The time taken for the induction of anaesthesia (minutes)
Measured: Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.
Analgesic use
Analgesia given in the recovery room
Measured: Day of surgery (Day 1): Recorded in the recovery room following surgery
Anti-emetic use
Anti-emetic use in the recovery room
Measured: Day of surgery (Day 1): Recorded in the recovery room following surgery
Time to recovery
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.
Measured: Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.
VAS- 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.
Measured: Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.
Time to discharge
The total time the participant spend in hospital from arrival on the ward to being discharged home (minutes).
Measured: Day of surgery (Day 1): Recorded at end of day of surgery following discharge.
Unplanned cancellations
Incidence of unplanned cancellations on the scheduled date of surgery
Measured: Day of surgery (Day 1): recorded prior to attempt of induction of anaesthesia
Adverse events questionnaire
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.
Measured: Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital
Unplanned admissions
The number of participants requiring unplanned admission to hospital following surgery for any reason.
Measured: Day of surgery (Day 1): Recorded at end of 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.
Measured: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
Number of days of work/school missed
The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.
Measured: 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.
Measured: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Number of days of work/school missed
The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.
Measured: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start9 Sep 2019
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety AcuteStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD, Study chair, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797716
- Sponsor's protocol ID
- 18/0197
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2018
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40010809
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03797716
- Acronym / sponsor ID
- 18/0197
- Conditions
- Anxiety Acute, Anxiety Fear, Peri-operative, Psychological Distress, Surgery, Children, Only
- Keywords
- Anxiety, peri-operative, preparation, app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care arm | No intervention | –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. |
| Intervention arm | Experimental | Device: Little Journey appParticipants 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 3-12 years of age on the date of parental consent to participate in the trial
- 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)
- Requiring general anaesthetic (must be their first general anaesthetic)
- Both child and parent able to speak / understand one of the languages available on the app
- American Society of Anesthesiologists' physical status class I-III
Key exclusion criteria (8 listed)
- Children aged less than 3 years of age or more than 12 years' old on the date of parental consent
- Any child and/or parent that refuses to be part of the study
- Patients and parents who do not speak one of the languages which are available on the app
- Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
- Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Little Journey appThe 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. | Device | Intervention arm |
Primary outcome
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
Time frame: Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room
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.
20 secondary outcomes
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
Time frame: 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.
VAS - Parent Anxiety (VAS-PA)
Time frame: 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.
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
Time frame: Day of Surgery (Day 1): Measured on the ward prior to surgery
VAS - Satisfaction with pre-operative information (VAS-SI)
Time frame: Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.
VAS - Compliance
Time frame: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
VAS Distress
Time frame: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
VAS - Parent Anxiety (VAS-PA)
Time frame: Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.
Time to induction
Time frame: Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.
Analgesic use
Time frame: Day of surgery (Day 1): Recorded in the recovery room following surgery
Anti-emetic use
Time frame: Day of surgery (Day 1): Recorded in the recovery room following surgery
Time to recovery
Time frame: Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.
VAS- Parent satisfaction with care
Time frame: Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.
Time to discharge
Time frame: Day of surgery (Day 1): Recorded at end of day of surgery following discharge.
Unplanned cancellations
Time frame: Day of surgery (Day 1): recorded prior to attempt of induction of anaesthesia
Adverse events questionnaire
Time frame: Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital
Unplanned admissions
Time frame: Day of surgery (Day 1): Recorded at end of day of surgery
Post Hospital Behavioural Questionnaire
Time frame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
Number of days of work/school missed
Time frame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
Post Hospital Behavioural Questionnaire
Time frame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Number of days of work/school missed
Time frame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 40010809Evans 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD study chair
University College, London
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Little Journey app in people with Anxiety Acute and Anxiety Fear, run by University College, London at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF) (time frame: Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.