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Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Play intervention
control
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • children with identified cognitive and learning difficulties

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    play intervention

    control

    Arm Description

    30 minutes of hospital play interventions

    usual care

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 8 - 12
    Anxiety levels of children aged between 8 and 12 were assessed by using the short-form Chinese version of the State Anxiety Scale for Children (CSAS-C). This consists of 10 items scored from 1 to 3, with total scores ranging from 10 to 30. Higher scores represent greater anxiety. They were asked to respond to this scale at 2 days after admission.
    baseline anxiety levels 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 baseline .
    baseline anxiety levels for children aged 8 -12
    Anxiety levels of children aged between 8 and 12 were assessed by using the short-form Chinese version of the State Anxiety Scale for Children (CSAS-C). This consists of 10 items scored from 1 to 3, with total scores ranging from 10 to 30. Higher scores represent greater anxiety. They were asked to respond to this scale at baseline.
    overall emotion behaviors for the 2-day period of hospitalization (CEMS)
    The emotions of the hospitalized children were assessed using the Children's Emotional Manifestation Scale (CEMS), which is an observation scale. The CEMS consists of five categories, each category scored from 1 to 5, with summed scores from 5 to 25. Higher scores represent more negative emotional behavior. The emotional behaviour of each child was observed by a research assistant for two consecutive days, at the end of which a research assistant documented the child's overall emotional behaviour, using the CEMS.

    Full Information

    First Posted
    January 17, 2016
    Last Updated
    January 22, 2016
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02665403
    Brief Title
    Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children
    Official Title
    Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    This study tested the effectiveness of play interventions to reduce anxiety and negative emotions in hospitalized children. Intervention Placebo control group In the control group, children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management. Experimental group In the experimental group, participants received around 30 minutes of hospital play interventions each day, conducted by hospital play specialists. The interventions in this study 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. Data Collection Methods Approval for the study was obtained from the hospital ethics committees. A research assistant collected demographic data from the parents and from the children's medical records after obtaining the consent form. The children's baseline anxiety levels were also documented. For the experimental group, the interventions started after the baseline data had been collected. The emotional behaviour of each child was observed by a research assistant for two consecutive days, at the end of which a research assistant documented the child's overall emotional behaviour, using the CEMS. The child's anxiety levels were reassessed and documented. Analysis The Statistical Package for Social Science (SPSS) software, version 20.0 for Windows was used for the data analysis. Descriptive statistics were used to calculate the means, standard deviations, and ranges of the scores on the various scales. The homogeneity of the two groups was examined using inferential statistics (independent t-test and chi-squared). The interrelationships among the scores on the different scales and the demographic variables were assessed using the Pearson product-moment correlation coefficient. Differences in the mean scores on the CEMS and the children's anxiety levels between the two intervention groups were investigated by an independent t-test and mixed between-within subjects ANOVA, respectively. Multiple regression analysis was performed to examine the effects of participants' demographic and clinical characteristics on the outcome measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    304 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    play intervention
    Arm Type
    Experimental
    Arm Description
    30 minutes of hospital play interventions
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    usual care
    Intervention Type
    Other
    Intervention Name(s)
    Play intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    control
    Intervention Description
    Children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management as a control treatment
    Primary Outcome Measure Information:
    Title
    Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 3 - 7
    Description
    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.
    Time Frame
    two days after admission
    Secondary Outcome Measure Information:
    Title
    Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 8 - 12
    Description
    Anxiety levels of children aged between 8 and 12 were assessed by using the short-form Chinese version of the State Anxiety Scale for Children (CSAS-C). This consists of 10 items scored from 1 to 3, with total scores ranging from 10 to 30. Higher scores represent greater anxiety. They were asked to respond to this scale at 2 days after admission.
    Time Frame
    two days after admission
    Title
    baseline anxiety levels for children aged 3 - 7
    Description
    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 baseline .
    Time Frame
    baseline
    Title
    baseline anxiety levels for children aged 8 -12
    Description
    Anxiety levels of children aged between 8 and 12 were assessed by using the short-form Chinese version of the State Anxiety Scale for Children (CSAS-C). This consists of 10 items scored from 1 to 3, with total scores ranging from 10 to 30. Higher scores represent greater anxiety. They were asked to respond to this scale at baseline.
    Time Frame
    baseline
    Title
    overall emotion behaviors for the 2-day period of hospitalization (CEMS)
    Description
    The emotions of the hospitalized children were assessed using the Children's Emotional Manifestation Scale (CEMS), which is an observation scale. The CEMS consists of five categories, each category scored from 1 to 5, with summed scores from 5 to 25. Higher scores represent more negative emotional behavior. The emotional behaviour of each child was observed by a research assistant for two consecutive days, at the end of which a research assistant documented the child's overall emotional behaviour, using the CEMS.
    Time Frame
    the 2-day period of hospitalization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: were Chinese children aged between 3 and 12, able to speak Cantonese required to stay in hospital for at least three consecutive days Exclusion Criteria: children with identified cognitive and learning difficulties
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ho Cheung, William LI, PhD
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan for making the data available to the public
    Citations:
    PubMed Identifier
    26969158
    Citation
    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.
    Results Reference
    derived

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