AnxietyNCT01909726
The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space
An observational study of Anxiety, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Anxiety
- What is being tested?
- ScreenPlay
- How many people
- 310 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants include clients, their parents/guardians, and staff associated with the outpatient clinic at Holland Bloorview Kids Rehabilitation Hospital.
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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- ScreenPlay
- Keywords
- Hospital Design, Technology, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreenPlayOther
Interactive technology
| Study group | Role | What they receive |
|---|---|---|
| Interactive media | ScreenPlay Receives: Other: ScreenPlay | |
| Passive media | Silent nature video | |
| No media | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory, STAI
The STAI is used to capture apprehension, tension, nervousness, and worry.
Measured: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
Secondary outcomes (2)
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.
Measured: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.
Faces Pain Scale Revised, Faces-R
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"
Measured: Immediately following medical/therapeutic intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Elaine Biddiss, PhD, M.A.Sc., Principal investigator, Holland Bloorview Kids Rehabilitation Hospital; University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909726
- Sponsor's protocol ID
- BloorviewKR
- Status last verified
- Jul 2014
- First submitted
- 30 Jan 2013
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space
- ClinicalTrials.gov ID
- NCT01909726
- Acronym / sponsor ID
- BloorviewKR
- Conditions
- Anxiety
- Keywords
- Hospital Design, Technology, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive media | – | Other: ScreenPlayScreenPlay |
| Passive media | – | –Silent nature video |
| No media | – | –Standard care |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants include clients, their parents/guardians, and staff associated with the outpatient clinic at Holland Bloorview Kids Rehabilitation Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreenPlayInteractive technology | Other | Interactive media |
Primary outcome
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.
2 secondary outcomes
Modified Yale Preoperative Anxiety Scale, mYPAS
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Biddiss, PhD, M.A.Sc. principal investigator
Holland Bloorview Kids Rehabilitation Hospital; University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Anxiety Inventory, STAI (time frame: Baseline, after 10 minutes of exposure to intervention, and immediately following appointment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.