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Clinical Trial Summary

To evaluate the efficacy of Health Support Activities (Animal Assisted Intervention, Clows, Musicians) in the reduction of pain and distress in children undergoing venipuncture.

Hypothesis: the investigators expect a reduction in in pain and distress.


Clinical Trial Description

Venipuncture is one of the most unpleasant procedures for children. Previous studies demonstrated the effectiveness of distraction techniques in reducing anxiety and pain but no one compares the specific activities of animals assisted intervention (AAI), clowns and musicians for this procedure.

In the Hospital involved in the present study, venipuncture service has a week schedule for Health Support Activities. In specific days children can benefit of Health Support Activities as part of routine care.

Aims of the present study are: evaluate efficacy of AAI, clowns and musicians in the reduction of childrens' distress and pain during venipuncture with respect of a control group undergoing venipuncture in the days where Health Support Activities are not scheduled; compare distress and pain levels between groups; evaluate caregiver's anxiety and its influence on child pain and distress; explore parents' and staff opinion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03899766
Study type Observational
Source Meyer Children's Hospital
Contact
Status Completed
Phase
Start date February 12, 2016
Completion date April 30, 2019

See also
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