<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797716</url>
  </required_header>
  <id_info>
    <org_study_id>18/0197</org_study_id>
    <nct_id>NCT03797716</nct_id>
  </id_info>
  <brief_title>Paediatric Peri-operative Anxiety: Does the Little Journey App Help?</brief_title>
  <acronym>Little Journey</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the clinical effectiveness of a virtual reality psychological preparation app at&#xD;
      reducing peri-operative anxiety and its associated sequelae in children aged 3-12 years old&#xD;
      undergoing ambulatory surgery compared to standard care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase III multi-centre randomised controlled trial evaluating the effectiveness of&#xD;
      the Little Journey app: a pre-hospital psychological preparation tool designed for children&#xD;
      undergoing ambulatory surgery.&#xD;
&#xD;
      Children presenting to the Preoperative assessment clinic before their operation will be&#xD;
      screened for recruitment to the trial. Those meeting the inclusion criteria will be recruited&#xD;
      to participate in the trial before randomisation into either a standard practice arm or&#xD;
      intervention arm. Consent will be provided by parents / guardians and assent by children aged&#xD;
      7-12 years old.&#xD;
&#xD;
      Children assigned to the intervention arm will be provided with a virtual reality google&#xD;
      cardboard headset and access code for the Little Journey app which they can use as many times&#xD;
      as they wish before their operation. They will also receive the standard pre-operative&#xD;
      preparation and care as per the recruiting site. In comparison, the standard care arm will&#xD;
      receive a google cardboard virtual reality headset with suggestions of free virtual apps to&#xD;
      use and standard pre-operative preparation and care - as defined by each participating site.&#xD;
&#xD;
      Children's anxiety will be assessed at multiple time points along the surgical journey,&#xD;
      ranging from the preoperative assessment clinic, ward and finally in the anaesthetic room&#xD;
      during the induction of anaesthesia. Secondary outcome measures such as parent anxiety&#xD;
      levels, post-hospital behavioural changes, need for rescue analgesia and antiemetics in the&#xD;
      recovery room will be recorded.&#xD;
&#xD;
      Children's anxiety scores in those assigned to the intervention arm will undergo a further&#xD;
      analysis assessing the impact of frequency and timing of Little Journey app use before&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Yale Pre Operative Anxiety score (shortened form)</measure>
    <time_frame>Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Yale Pre Operative Anxiety score (shortened form)</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent anxiety levels</measure>
    <time_frame>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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Yale Pre Operative Anxiety score (shortened form)</measure>
    <time_frame>Day of Surgery (Day 1): Measured on the ward prior to surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent satisfaction with pre-operative information</measure>
    <time_frame>Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child compliance in the anaesthetic room</measure>
    <time_frame>Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child distress in the anaesthetic room</measure>
    <time_frame>Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent anxiety levels</measure>
    <time_frame>Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to induction of anaesthesia</measure>
    <time_frame>Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.</time_frame>
    <description>The time taken for the induction of anaesthesia (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of the need for premedication</measure>
    <time_frame>Day of surgery (Day 1): As recorded in the anaesthetic room</time_frame>
    <description>Number of patients given premedication prior to the induction of anaesthesia as per the prescription of the anaesthetist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesia and anti-emetic use in the recovery room.</measure>
    <time_frame>Day of surgery (Day 1): Recorded in the recovery room following surgery</time_frame>
    <description>As directed by the trial arm blinded clinical team based on their perceptions of child's symptoms in the recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recovery readiness</measure>
    <time_frame>Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent satisfaction with care</measure>
    <time_frame>Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in hospital</measure>
    <time_frame>Day of surgery (Day 1): Recorded at end of day of surgery following discharge.</time_frame>
    <description>The total time the participant spend in hospital from arrival on the ward to being discharged home (minutes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Virtual reality headset side effects</measure>
    <time_frame>Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of unplanned admissions to hospital following surgery</measure>
    <time_frame>Day of surgery (Day 1): Recorded at end of day of surgery</time_frame>
    <description>The number of participants requiring unplanned admission to hospital following surgery for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of unplanned cancellations on the scheduled date of surgery.</measure>
    <time_frame>Day of surgery (Day 1): Recorded on the day of surgery</time_frame>
    <description>The number of participants whose surgery is cancelled on the day of surgery for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Hospital Behavioural Questionnaire</measure>
    <time_frame>Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians</time_frame>
    <description>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 &quot;much less than before&quot; to &quot; much more than before&quot;. Higher scores are suggestive of increased post hospital regressive behavioural changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social cost analysis (Parents/Guardian)</measure>
    <time_frame>Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians</time_frame>
    <description>The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social cost analysis (Participants)</measure>
    <time_frame>Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians</time_frame>
    <description>The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Hospital Behavioural Questionnaire</measure>
    <time_frame>Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians</time_frame>
    <description>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 &quot;much less than before&quot; to &quot; much more than before&quot;. Higher scores are suggestive of increased post hospital regressive behavioural changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social cost analysis (Parents/Guardian)</measure>
    <time_frame>Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians</time_frame>
    <description>The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social cost analysis (Participants)</measure>
    <time_frame>Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians</time_frame>
    <description>The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">304</enrollment>
  <condition>Anxiety Acute</condition>
  <condition>Anxiety Fear</condition>
  <condition>Peri-operative</condition>
  <condition>Psychological Distress</condition>
  <condition>Surgery</condition>
  <condition>Children, Only</condition>
  <arm_group>
    <arm_group_label>Standard Care arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard of care from the pre-assessment clinic until discharge.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Little Journey app</intervention_name>
    <description>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 &quot;visit&quot; 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.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged between 3-12 years of age on the date of parental consent to participate&#xD;
             in the trial&#xD;
&#xD;
          2. Those undergoing surgery planned to be conducted as a day-case (surgery is defined as&#xD;
             any therapeutic procedure taking place under the care of an anaesthetist and surgeon&#xD;
             or dentist)&#xD;
&#xD;
          3. Requiring general anaesthetic (must be their first general anaesthetic)&#xD;
&#xD;
          4. American Society of Anesthetists physical status class I-III&#xD;
&#xD;
          5. Both child and parent able to speak / understand one of the languages available on the&#xD;
             Little Journey app (to be confirmed)&#xD;
&#xD;
        Note: Surgery is defined as any procedure occurring in a theatre under the care of a&#xD;
        surgeon or dentist and an anaesthetist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children aged less than 3 years of age or more than 12 years' old on the date of&#xD;
             parental consent&#xD;
&#xD;
          2. Any child and/or parent that refuses to be part of the study&#xD;
&#xD;
          3. Patients and parents who do not speak one of the languages which are available on the&#xD;
             app&#xD;
&#xD;
          4. American Society of Anesthetists physical status class IV-VI&#xD;
&#xD;
          5. Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)&#xD;
&#xD;
          6. Any child with a visual or hearing impairments significant enough to prevent use of&#xD;
             the intervention as decided on case-by-case basis.&#xD;
&#xD;
        Note: Children undergoing diagnostic procedures (e.g. MRI, Cardiac catheterisation) will&#xD;
        not be included due to diagnostic uncertainty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christopher R Evans, MBBS</last_name>
    <phone>02076799280</phone>
    <email>situ.littlejourney@ucl.ac.uk</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anxiety, peri-operative, preparation, app</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797716
org study id: 18/0197
nct id: NCT03797716
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Care Provider, Outcomes Assessor)
measure: Modified Yale Pre Operative Anxiety score (shortened form)
time frame: Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room
description: 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.
measure: Modified Yale Pre Operative Anxiety score (shortened form)
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.
description: 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.
measure: Parent anxiety levels
time frame: 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.
description: 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.
measure: Modified Yale Pre Operative Anxiety score (shortened form)
time frame: Day of Surgery (Day 1): Measured on the ward prior to surgery
description: 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.
measure: Parent satisfaction with pre-operative information
time frame: Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.
description: 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.
measure: Child compliance in the anaesthetic room
time frame: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
description: 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.
measure: Child distress in the anaesthetic room
time frame: Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia
description: 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.
measure: Parent anxiety levels
time frame: Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.
description: 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.
measure: Time to induction of anaesthesia
time frame: Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.
description: The time taken for the induction of anaesthesia (minutes)
measure: Incidence of the need for premedication
time frame: Day of surgery (Day 1): As recorded in the anaesthetic room
description: Number of patients given premedication prior to the induction of anaesthesia as per the prescription of the anaesthetist.
measure: Analgesia and anti-emetic use in the recovery room.
time frame: Day of surgery (Day 1): Recorded in the recovery room following surgery
description: As directed by the trial arm blinded clinical team based on their perceptions of child's symptoms in the recovery room.
measure: Time to recovery readiness
time frame: Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.
description: 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.
measure: Parent satisfaction with care
time frame: Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.
description: 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.
measure: Time spent in hospital
time frame: Day of surgery (Day 1): Recorded at end of day of surgery following discharge.
description: The total time the participant spend in hospital from arrival on the ward to being discharged home (minutes).
measure: Virtual reality headset side effects
time frame: Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital
description: 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.
measure: Incidence of unplanned admissions to hospital following surgery
time frame: Day of surgery (Day 1): Recorded at end of day of surgery
description: The number of participants requiring unplanned admission to hospital following surgery for any reason.
measure: Incidence of unplanned cancellations on the scheduled date of surgery.
time frame: Day of surgery (Day 1): Recorded on the day of surgery
description: The number of participants whose surgery is cancelled on the day of surgery for any reason.
measure: Post Hospital Behavioural Questionnaire
time frame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
description: 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.
measure: Social cost analysis (Parents/Guardian)
time frame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
description: The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.
measure: Social cost analysis (Participants)
time frame: Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians
description: The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.
measure: Post Hospital Behavioural Questionnaire
time frame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
description: 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.
measure: Social cost analysis (Parents/Guardian)
time frame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
description: The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs.
measure: Social cost analysis (Participants)
time frame: Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians
description: The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs.
arm group label: Standard Care arm
arm group type: No Intervention
description: 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.
arm group label: Intervention arm
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Little Journey app
description: 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.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD
role: Study Chair
affiliation: University College, London
last name: Christopher R Evans, MBBS
phone: 02076799280
email: situ.littlejourney@ucl.ac.uk
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No