Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05196230 |
| Other study ID # |
eREB#209 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Holland Bloorview Kids Rehabilitation Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to evaluate the effectiveness of virtual reality (360° video)
compared to a social story for reducing pre-visit dental anxiety for children with autism
spectrum disorder (ASD) improve the dental visit experience for children, their families, and
clinicians. The secondary objective is to perform a cost comparison analysis of the 360°
video product as compared to a social story for Holland Bloorview's dental clinic.
Description:
Participation in this research study will include daily at-home use of either the 360° video
(experimental condition) or social story (control condition) for seven days prior to
participant's first visit to the dental clinic, as well as parent, child, and dental
clinician questionnaires. Both pre-visit experiences will be delivered remotely, in-home, and
through the use of a study-provided tablet. Participants will be asked to access the
pre-visit experience exclusively through use of the study-provided tablet, and to document
daily use of the tablet experience on a Daily Journal log provided to families with the
tablet. Tablets will have the assigned pre-visit experience pre-loaded (360° video or social
story) and will be locked with a passcode, to ensure that participants do not engage with the
tablet or pre-visit experience prior to 7-days before their dental visit. Tablets and
pre-visit questionnaires will be mailed out to families two weeks prior to their onsite
dental appointment. One week plus one business day prior to their initial dental visit at
Holland Bloorview, families will be contacted by telephone to provide them with the tablet
passcode so participants can access their assigned pre-visit experience (360° video or social
story) and to remind them of the study protocol. Parents can be provided with a copy of the
instructions by email as well if participants prefer, however, tablet passcodes will only be
provided over the telephone.
Randomization This will be a single-blinded study, whereby participants will know which
experimental group participants have been allocated to, but the dental clinician will not.
Research study staff will also be aware of participant allocation.
Experimental Condition (360° Video) The 360° video has been developed by Shaftesbury Films in
consultation with Holland Bloorview dental, research study staff, and family advisors. The
360° video is from the point of view of a seated dental client and the participant will be
able to explore the scene around them (navigating through the tablet's touch screen). The
simulation will include scenes/features that may be anxiety-provoking for some participants.
These will include loud noises commonly encountered in the dentist's office (e.g. tooth
brushing, dental drills), as well as social stimuli (e.g. the dental clinician), and new
environments (e.g., the dental visit room). The investigators will ensure that participants
understand that they can stop at any time (e.g., if participants are feeling anxious or
overwhelmed), and the investigators will ask parents to explore the 360° video with their
child.
Control Condition (Social Story) The control condition is a social story, which is treatment
as usual for preparing clients for their initial visit at Holland Bloorview's dental clinic.
As for the experimental condition, the control condition will be delivered through the study
tablet. The investigators will ask parents to read it to their child once a day for the week
leading up to their appointment. If the child is reading on their own, the investigators will
request that parents be in the room with participants. The social story takes approximately
five minutes to read.
PRE-DENTAL VISIT
Parent Questionnaires One week plus one business day prior to dental visit, parents will
receive a reminder call (and email, if requested) from study staff. This will be to provide
families with the tablet passcode and remind them to fill out the questionnaires and of the
pre-visit experience protocol. Parents will be asked to fill out questionnaires
characterizing their child prior to their onsite dental visit. The questionnaires will
collect information on the following domains: demographic and prior dental experience
(Demographic and Prior Experience Questionnaire), child's sensory profile (Short Sensory
Profile (SSP)), anxiety (Screen for Anxiety Related Disordered (SCARED)), ASD symptomatology
(Social Communication Questionnaire (SCQ)), and any co-morbidities (Child Behaviour Checklist
(CBCL)). Questionaries will be mailed to participants two weeks prior to their dental visit,
along with the study tablet. Parents will be asked to bring the complete questionnaires and
study tablet with them to their dental visit to return to study staff. If parents fail to
return study tablet and/or questionnaires, staff will provide them with prepaid and labelled
shipping envelopes for the study tablet and/or questionnaires to be returned in the mail.
DAY OF DENTAL VISIT
Research families will be asked to come to Holland Bloorview 30-minutes ahead of their
scheduled appointment time with the dental clinic. Research study staff will be waiting at
Reception for the family to check in, at which point participants will provide the family
with the questionnaire to fill out and invite participants to put on the smartwatch.
Smartwatch (Physiological Signal Recording) Participants will be asked to wear a Samsung
Galaxy smartwatch to record time-stamped heart rate (electrocardiogram) and accelerometry
signals. The functionality of the smartwatch will be restricted for study purposes (user
cannot launch apps or change settings). The smartwatch will record continuously from the time
it is put on the participant until it is taken off by study staff in the waiting room at the
end of their visit. Study staff will indicate on the watch (set a 'marker') when the
participant is beginning their dental visit (upon leaving waiting area). As an exploratory
aim, the investigators will examine the change in physiological indices (average heart rate,
heart rate variability) before and during the dental visit obtained from the smartwatch.
Participant Questionnaire Participants will be asked to fill out a brief questionnaire to
assess their level of pre-visit anxiety (State-Trait Anxiety Inventory - for Children
(STAI-CH) "How I Feel Questionnaire"). As the investigators are not excluding participants
based on cognitive or verbal abilities, STAI-CH can be filled out with the help of a parent,
if needed.
POST-DENTAL VISIT
Clinician Questionnaire The dental clinician will be required to fill out a post-visit
questionnaire at the end of the participant's dental visit to assess visit completeness
(progression through 5-steps). This questionnaire also contains one question assessing the
participant's behavior (Frankl behavior rating scale), and two questions regarding blinding:
the first probes whether or not the participant/family disclosed their group allocation; the
second asks the clinician to guess which group they believed the participant was allocated
to.
Parent Questionnaires Parents will be asked to complete a brief custom follow-up
questionnaire after their child's dental appointment, assessing their provision of the
pre-visit experience to their child over the past week and their experience traveling to
Holland Bloorview for their dental appointment. This questionnaire will be conducted by study
staff with parents within two business days of their dental appointment, by telephone or
Zoom, as preferred. If the parent wishes to complete the follow-up questionnaire with study
staff immediately following their child's dental appointment, they will be able to. Study
staff will schedule the follow-up questionnaire with parents in the dental waiting area
before their child's dental appointment.
