NCT03586180

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

June 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 10, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

June 4, 2018

Last Update Submit

August 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (2)

children and their parents

aged 4-18 children with cancer/blood disease and their parents

Behavioral: Medical Clowning for children

Dr. Clowns

they will perform shows for children and parents

Behavioral: Medical Clowning for children

Interventions

Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures.

Dr. Clownschildren and their parents

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease

You may qualify if:

  • aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease

You may not qualify if:

  • older than aged 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Universtiy Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Hematologic DiseasesNeoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 13, 2018

Study Start

June 7, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

August 10, 2020

Record last verified: 2020-05

Locations