Clinical trial NCT03899766: Support Activities for the Reduction of Distress and Pain in Children During Venipuncture
Official title: Animal Assisted Activity, Clowns and Music for the Reduction of Distress and Pain in Children During Venipuncture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venipuncture
Keywords: pain, procedural
child
anxiety
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatiens reffering to hospital for venipuncture

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* outpatients
* scheduled to venipuncture
* Italian speaking

Exclusion Criteria:

* cognitive and/or developmental impairment

Primary outcomes:
measure: Distress
timeFrame: Distress assessment is one for every participant and begins when child enter in the venipuncture room and lasts until the child exit the venipuncture room, in the day of recruitment. .
measure: Pain perception 3-6 years old
timeFrame: Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment
measure: Pain perception from 7 years old
timeFrame: Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment
Secondary outcomes:
measure: Parent's state and trait anxiety
timeFrame: Parent's anxiety assessment is one for every participant, measured in the waiting room before child enters in the venipuncture room, in the day of recruitment
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Andrea Messeri, MD
role: STUDY_DIRECTOR
affiliation: Meyer Children's Hospital IRCCS
name: Laura Vagnoli, MSc
role: PRINCIPAL_INVESTIGATOR
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