Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children

Anxiety Clinical Trial

Official title:

Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665403
• Other study ID #: KW/FR-12-020
• Status: Completed
• Phase: N/A
• First received: January 17, 2016
• Last updated: January 22, 2016
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No