Support Activities for the Reduction of Distress and Pain in Children During Venipuncture

Meyer Children's Hospital IRCCS

Status: Completed

Conditions: Venipuncture

Treatments: Other: Musicians; Other: Animal Assisted Intervention; Other: Clowns

Study type: Observational

Funder types: Other

Identifiers

NCT03899766

SupportActivities_Venipuncture

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• outpatients
• scheduled to venipuncture
• Italian speaking

Exclusion criteria

• cognitive and/or developmental impairment

Trial design

600 participants in 4 patient groups

Animal Assisted Intervention

Description:

children interact and play with the expert of Animal Assisted Intervention (AAI) and his/her trained dog in the waiting room and then, are accompanied by a parent (as standard care) and the AAI in the venipuncture room during and immediately after the procedure

Treatment:

Other: Animal Assisted Intervention

Clowns

Description:

children interact and play with hospital clowns in the waiting room and then, are accompanied by a parent (as standard care) and the clown in the venipuncture room during and immediately after the procedure

Treatment:

Other: Clowns

Musicians

Description:

children interact and play with a musician in the waiting room and then, are accompanied by a parent (as standard care) and the musician in the venipuncture room during and immediately after the procedure

Treatment:

Other: Musicians

Non-clinical Conversation

Description:

children are accompanied by a parent in the waiting room and then in the venipuncture room during the procedure, thus receiving standard care