Clinical trial NCT01909726: The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space
Official title: The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Hospital Design
Technology
Anxiety
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-07-26
Enrollment: 310
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants include clients, their parents/guardians, and staff associated with the outpatient clinic at Holland Bloorview Kids Rehabilitation Hospital.

Brief summary: The purpose of this study is to test the hypothesis that providing low-intensity opportunities for interactive play can improve the waiting and overall clinic experiences of children. This study evaluates an innovative, interactive system called ScreenPlay designed to realize the intentions of the "Healing Environment" in the waiting space of a paediatric hospital.

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):

1. reduce state anxiety in children/youth attending an outpatient clinic? and,
2. improve child, parent, and staff satisfaction with the clinic experience?

We hypothesize that:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Participants include clients, their parents/guardians, and staff associated with the outpatient clinic at Holland Bloorview Kids Rehabilitation Hospital.

1. Children and youth aged 5 to 19 years and their guardian/parent.
2. Anticipated wait time ≥30 minutes to allow time to complete the study.
3. 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.
4. All outpatient clinic staff

Primary outcomes:
measure: State Trait Anxiety Inventory, STAI
timeFrame: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
Secondary outcomes:
measure: Modified Yale Preoperative Anxiety Scale, mYPAS
timeFrame: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
measure: Faces Pain Scale Revised, Faces-R
timeFrame: Immediately following medical/therapeutic intervention.
Other outcomes:
measure: Behaviour Mapping
timeFrame: Administered during the participant's 10 minute exposure to the intervention.
measure: Contact sensors
timeFrame: Data from sensors is continuously collected from 7am to 5pm from beginning of data collection (June 2012) to end of data collection (April 2013)
measure: Feedback questionnaires
timeFrame: Child and parent surveys are administered post-exposure. Staff surveys will be administered nearing the end of the recruitment deadline.
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital; University of Toronto
name: Elaine Biddiss, PhD, M.A.Sc.
role: PRINCIPAL_INVESTIGATOR
References: