Blood DiseaseNCT03586180
Medical Clowning: Needs Assessment and Implication for Hospitalized Children With Cancer/Blood Disease
An observational study of Blood Disease and Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hospitalized children who undergo painful procedures are more susceptible than others to experiencing iatrogenic effects, such as anxiety, pain, and severe stress. Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Disease, Cancer, Friendly Healthcare in Children
- What is being tested?
- Medical Clowning for children
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 148 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2018to 31 Mar 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease
Who may be able to join
- aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease
Who cannot join
- older than aged 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Clowning: Needs Assessment, Implication, and Evaluation for Children and Adolescents With Cancer Using Child Friendly Healthcare
Hospitalized children who undergo painful procedures are more susceptible than others to experiencing iatrogenic effects, such as anxiety, pain, and severe stress. Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures. This article provides an overview of clowning in health care settings; reviews major studies conducted on clowning for hospitalized children, discussing evidence that clown interventions decrease pain and distress in pediatric patients; and concludes with a discussion of health care clowning as a profession.
- Conditions
- Blood Disease, Cancer, Friendly Healthcare in Children, Medical Clown, Hospitalized Children
- Being tested
- Medical Clowning for children
- Medical subject headings
- Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Clowning for childrenBehavioural
Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures.
| Study group | Role | What they receive |
|---|---|---|
| children and their parents | aged 4-18 children with cancer/blood disease and their parents Receives: Behavioral: Medical Clowning for children | |
| Dr. Clowns | they will perform shows for children and parents Receives: Behavioral: Medical Clowning for children |
What is being measured
The primary outcome is the main question the study is designed to answer.
experience and influence from medical clowning for children and their parents
Children with cancer/blood disease and their parents would use self-report to complete the questionnaire after medical clowning. Using Face Rating Scale (1=very unhappy to 5=very happy) for measuring emotion state (pre-emotion for before medical clowning and post-emotion for after medical clowning). It can understand whether their emotion state change before/after medical clowning or not.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start7 Jun 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586180
- Sponsor's protocol ID
- 201803121RINB
- Status last verified
- May 2020
- First submitted
- 4 Jun 2018
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Clowning: Needs Assessment, Implication, and Evaluation for Children and Adolescents With Cancer Using Child Friendly Healthcare
- ClinicalTrials.gov ID
- NCT03586180
- Acronym / sponsor ID
- 201803121RINB
- Conditions
- Blood Disease, Cancer, Friendly Healthcare in Children, Medical Clown, Hospitalized Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Jul 2018 (actual)
- 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.
Hospitalized children who undergo painful procedures are more susceptible than others to experiencing iatrogenic effects, such as anxiety, pain, and severe stress. Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures. This article provides an overview of clowning in health care settings; reviews major studies conducted on clowning for hospitalized children, discussing evidence that clown interventions decrease pain and distress in pediatric patients; and concludes with a discussion of health care clowning as a profession.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children and their parents | – | Behavioral: Medical Clowning for childrenaged 4-18 children with cancer/blood disease and their parents |
| Dr. Clowns | – | Behavioral: Medical Clowning for childrenthey will perform shows for children and parents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease
Key inclusion criteria (1 listed)
- aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease
Key exclusion criteria (1 listed)
- older than aged 18
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 |
|---|---|---|
| Medical Clowning for childrenClowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures. | Behavioural | Dr. Clowns, children and their parents |
Primary outcome
experience and influence from medical clowning for children and their parents
Time frame: 1 year
Children with cancer/blood disease and their parents would use self-report to complete the questionnaire after medical clowning. Using Face Rating Scale (1=very unhappy to 5=very happy) for measuring emotion state (pre-emotion for before medical clowning and post-emotion for after medical clowning). It can understand whether their emotion state change before/after medical clowning or not.
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 10 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
experience and influence from medical clowning for children and their parents (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2020.