- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909726
The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space
Study Overview
Detailed Description
Existing entertainment and distraction options (e.g. toys, video games) meet neither organizational standards nor families' needs with respect to accessibility and infection control. Additionally, they do not provide the types of positive experiences (e.g. calm, low intensity) that are most desirable for children awaiting treatment.
The goal of this research is to empirically evaluate the effectiveness of ScreenPlay, a technology that enables users to create or manipulate animations on a screen/projection, and to provide an evidence-informed model for the design of optimal paediatric waiting spaces. A blinded, clustered, parallel randomized controlled trial applying objective outcome measures and qualitative methods will be used to compare children allocated to one of three waiting conditions at a large urban rehabilitation hospital: (a) no media (standard care), (b) passive media (a silent nature video), or (c) interactive media (ScreenPlay). This study will answer the questions:
Can Interactive Media (i.e. ScreenPlay):
- reduce state anxiety in children/youth attending an outpatient clinic? and,
- improve child, parent, and staff satisfaction with the clinic experience?
We hypothesize that:
- Decreases in state anxiety will be greater for children exposed to ScreenPlay for 10 minutes than for those exposed to passive (i.e. a nature video) or no media (i.e. standard care/control). The decrease in state anxiety associated with ScreenPlay will be >5 points on the normalized 100 point State Anxiety Scale.
- ScreenPlay will generate more movement/activity on the floor (i.e. an indicator of active engagement with the system) than the passive media or control conditions as measured via contact floor sensors.
- The waiting and overall clinic experience of children with diverse mobility, parents, and staff will be perceived more positively when exposed to ScreenPlay as compared to passive media or control conditions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Participants include clients, their parents/guardians, and staff associated with the outpatient clinic at Holland Bloorview Kids Rehabilitation Hospital.
- Children and youth aged 5 to 19 years and their guardian/parent.
- Anticipated wait time ≥30 minutes to allow time to complete the study.
- Ability to communicate in English through speech, writing/typing, or other communication device. Note: For children who cannot communicate their thoughts/feelings, parent-proxy may be used.
- All outpatient clinic staff
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Interactive media
ScreenPlay
|
Interactive technology
|
|
Passive media
Silent nature video
|
|
|
No media
Standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Trait Anxiety Inventory, STAI
Time Frame: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
|
The STAI is used to capture apprehension, tension, nervousness, and worry.
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Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Yale Preoperative Anxiety Scale, mYPAS
Time Frame: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
|
The mYPAS observes activity, vocalizations, emotion expressivity, state of arousal, and use of parents, to ascertain children's anxiety state.
|
Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
|
|
Faces Pain Scale Revised, Faces-R
Time Frame: Immediately following medical/therapeutic intervention.
|
Faces-R is used to capture self-reported pain.
The scale is composed of 6 gender neutral faces showing increasing levels pain/hurt from "no pain" to "most pain possible"
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Immediately following medical/therapeutic intervention.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behaviour Mapping
Time Frame: Administered during the participant's 10 minute exposure to the intervention.
|
An unobtrusive, observational technique used to systematically define/record distinct behaviours including: mobility, activities, social interactions, emotion expressivity, attention/engagement, and description of challenges encountered.
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Administered during the participant's 10 minute exposure to the intervention.
|
|
Contact sensors
Time Frame: Data from sensors is continuously collected from 7am to 5pm from beginning of data collection (June 2012) to end of data collection (April 2013)
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ScreenPlay incorporates a 'pressure' floor composed of 100 contact sensors arranged in a 10 foot by 10 foot grid.
Activity metrics (e.g.
number, duration, and frequency of activations) are extracted for each contact sensor and for the amalgamated grid.
|
Data from sensors is continuously collected from 7am to 5pm from beginning of data collection (June 2012) to end of data collection (April 2013)
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Feedback questionnaires
Time Frame: Child and parent surveys are administered post-exposure. Staff surveys will be administered nearing the end of the recruitment deadline.
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The surveys inquire into child, parent, and staff perceptions of the waiting space and their overall clinic experience through a mixture of open- and close-ended (e.g.
Likert scale) questions.
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Child and parent surveys are administered post-exposure. Staff surveys will be administered nearing the end of the recruitment deadline.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elaine Biddiss, PhD, M.A.Sc., Holland Bloorview Kids Rehabilitation Hospital; University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BloorviewKR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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