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

About this trial
This is an interventional supportive care trial for Anxiety
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
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
NCT ID
NCT02665403
First Posted
January 17, 2016
Last Updated
January 22, 2016
Sponsor
The University of Hong Kong
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
Learn more about this trial
Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children
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