The Art of Waiting: Evaluation of an Interactive Media Ex... | NCT01909726

Studies
The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space

NCT01909726

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Status

Completed

Last Update Posted

Aug 1, 2014Estimated

Enrollment

310Actual

Phase

Not provided

Conditions

Anxiety

Interventions

ScreenPlay

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jan 30, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2014

Last Update Posted Date

Aug 1, 2014Estimated

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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):

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Interactive media	ScreenPlay	Other: ScreenPlay
Passive media	Silent nature video
No media	Standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ScreenPlay	Other	Interactive technology	Interactive media

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
State Trait Anxiety Inventory, STAI	The STAI is used to capture apprehension, tension, nervousness, and worry.	Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.

Secondary Outcomes

Measure	Description	Time Frame
Modified Yale Preoperative Anxiety Scale, mYPAS	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

Other Outcomes

Measure	Description	Time Frame
Behaviour Mapping	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.	Administered during the participant's 10 minute exposure to the intervention.

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elaine Biddiss, PhD, M.A.Sc.	Holland Bloorview Kids Rehabilitation Hospital; University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holland Bloorview Kids Rehabilitation Hospital		Toronto	Ontario	M4G 1R8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided