Procedural Pain in Children: Intervention With the Hospital Clown
Hospitalized Children's Pain Experience. Effect and Influence of Intervention With the Hospital Clown in Acute and Repeated Painful Procedures. A Mixed Method Study.
1 other identifier
interventional
111
0 countries
N/A
Brief Summary
This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2017
CompletedFirst Submitted
Initial submission to the registry
November 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedDecember 8, 2017
December 1, 2017
9 months
November 30, 2017
December 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
Self-reported pain measure conducted after finishing the venipuncture in the examining room
During a time interval of between 0-5 minutes
Study Arms (2)
Hospital clown intervention
OTHERThe performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure. The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel.
No hospital clown intervention
OTHERThe clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques.
Interventions
Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.
Eligibility Criteria
You may qualify if:
- Acutely admitted to the hospital
- Scheduled for the venipuncture procedure
- Not prepared for the procedure before coming to the hospital
- Accompanied by at least one parent
You may not qualify if:
- Subjects with developmental disorders who could not cooperate with self- reporting of pain
- Subjects who were unable to speak Danish or English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aalborg University Hospitallead
- Aalborg Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helle N Kristensen
Aalborg University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.d. student
Study Record Dates
First Submitted
November 30, 2017
First Posted
December 8, 2017
Study Start
April 18, 2016
Primary Completion
January 18, 2017
Study Completion
January 18, 2017
Last Updated
December 8, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share