NCT02665403

Brief Summary

Hospitalization is a stressful and threatening experience, which can be emotionally devastating to children. Hospital play interventions have been widely used to prepare children for invasive medical procedures and hospitalization. Nevertheless, there is an imperative need for rigorous empirical scrutiny of the effectiveness of hospital play interventions, in particular, using play activities to ease the psychological burden of hospitalized children. This study tested the effectiveness of play interventions to reduce anxiety and negative emotions in hospitalized children. A non-equivalent control group pre-test and post-test, between subjects design was conducted in the two largest acute-care public hospitals in Hong Kong. A total of 304 Chinese children (ages 3-12) admitted for treatments in these two hospitals were invited to participate in the study. Of the 304 paediatric patients, 154 received hospital play interventions and 150 received usual care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Nov 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 17, 2016

Last Update Submit

January 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 3 - 7

    Anxiety levels of children aged between 3 and 7 were assessed by using the Visual Analogue Scale , which consists of a 10 cm horizontal line on a piece of card, with different facial expressions supplemented by the words 'I have no anxiety' at one end and 'I have so much anxiety' at the other. They were asked to respond to this scale at 2 days after admission.

    two days after admission

Secondary Outcomes (4)

  • Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 8 - 12

    two days after admission

  • baseline anxiety levels for children aged 3 - 7

    baseline

  • baseline anxiety levels for children aged 8 -12

    baseline

  • overall emotion behaviors for the 2-day period of hospitalization (CEMS)

    the 2-day period of hospitalization

Study Arms (2)

play intervention

EXPERIMENTAL

30 minutes of hospital play interventions

Other: Play intervention

control

PLACEBO COMPARATOR

usual care

Other: control

Interventions

participants received around 30 minutes of hospital play interventions each day, conducted by hospital play specialists. Such interventions consisted of structured and non-structured activities. All these activities were given at the patients' bedside, with or without parental supervision, either once or spreading over an hour, depending on the ward routine.

play intervention
controlOTHER

Children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management as a control treatment

control

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • were Chinese children aged between 3 and 12,
  • able to speak Cantonese
  • required to stay in hospital for at least three consecutive days

You may not qualify if:

  • children with identified cognitive and learning difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ho Cheung, William LI, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2016

First Posted

January 27, 2016

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 27, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

No plan for making the data available to the public