AnxietyNCT02665403
Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children
A study testing Play intervention in people with Anxiety, run by The University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Play intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- were Chinese children aged between 3 and 12,
- able to speak Cantonese
- required to stay in hospital for at least three consecutive days
Who cannot join
- children with identified cognitive and learning difficulties
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Play intervention, control
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play interventionOther
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.
controlOther
Children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management as a control treatment
| Study group | Role | What they receive |
|---|---|---|
| play intervention | Experimental | 30 minutes of hospital play interventions Receives: Other: Play intervention |
| control | Placebo comparator | usual care Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: the 2-day period of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung, William LI, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665403
- Sponsor's protocol ID
- KW/FR-12-020
- Status last verified
- Jan 2016
- First submitted
- 17 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan for making the data available to the public
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.
PubMed 26969158
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children
- ClinicalTrials.gov ID
- NCT02665403
- Acronym / sponsor ID
- KW/FR-12-020
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| play intervention | Experimental | Other: Play intervention30 minutes of hospital play interventions |
| control | Placebo comparator | Other: controlusual care |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- were Chinese children aged between 3 and 12,
- able to speak Cantonese
- required to stay in hospital for at least three consecutive days
Key exclusion criteria (1 listed)
- children with identified cognitive and learning difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play interventionparticipants 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. | Other | play intervention |
| controlChildren received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management as a control treatment | Other | control |
Primary outcome
Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 3 - 7
Time frame: two days after admission
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.
4 secondary outcomes
Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 8 - 12
Time frame: two days after admission
baseline anxiety levels for children aged 3 - 7
Time frame: baseline
baseline anxiety levels for children aged 8 -12
Time frame: baseline
overall emotion behaviors for the 2-day period of hospitalization (CEMS)
Time frame: the 2-day period of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 26969158Li 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.
- Individual participant dataSharing planned: No. No plan for making the data available to the public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Cheung, William LI, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Play intervention in people with Anxiety, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 3 - 7 (time frame: two days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.