Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Play intervention; Other: control

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: play intervention; 30 minutes of hospital play interventions	Other: Play intervention; 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.
Placebo Comparator: control; usual care	Other: control; Children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management as a control treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two 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
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.	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.	the 2-day period of hospitalization

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Ho Cheung, William LI, PhD, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 17, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KW/FR-12-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan for making the data available to the public