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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Animal Assisted Activity, Clowns and Music for the Reduction of Distress and Pain in Children During Venipuncture

Conditions
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Venipuncture

Intervention / Treatment
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* Other: Animal Assisted Intervention
* Other: Clowns
* Other: Musicians


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: outpatients scheduled to venipuncture Italian speaking Exclusion Criteria: cognitive and/or developmental impairment

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Animal Assisted Intervention<br>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 | Other: Animal Assisted Intervention<br>* Operators of AAI and their dog meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.<br>|
| Clowns<br>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 | Other: Clowns<br>* Hospital clowns meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.<br>|
| Musicians<br>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 | Other: Musicians<br>* Musicians meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.<br>|
| Non-clinical Conversation<br>children are accompanied by a parent in the waiting room and then in the venipuncture room during the procedure, thus receiving standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress | Brief Behavioral Distress Scale - BBDS is an observational measure that assess children's procedure-related distress with 12 discrete component steps involved in venipuncture, in order to observe specific demands for compliance on the child during the procedure. Observers record the occurrence or nonoccurrence of the target behaviors during each step. Operational definitions of the target behaviors for each category are: 1) Non interfering Distress Behaviors; 2) Potentially Interfering Distress Behaviors; 3) Interfering Distress Behaviors. The number of steps in which a behavior occur is summed and divided by the total number of steps, then multiplied by 100 to yield percentage of steps with occurrence scores for each behavioral category. The number of steps in which behaviors from any of the three distress behavior categories occur is summed and divided by the total number of steps multiplied by three, then multiplied by 100 to obtain the Total Distress Score. | 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. . | 
| Pain perception 3-6 years old | Numerical scales, based on age, Wong Baker Scale. The Wong Baker Faces Pain Rating Scale (Wong & Baker, 1998) is a self-report scale for children older than 3 years old, that shows a sequence of faces ranging from a happy face at 0 level, that means No hurt, to a crying face at 10th level, that means Hurts worst. | Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment | 
| Pain perception from 7 years old | Numerical scale, Visual Analogue Scale - VAS. VAS is used from the age of 7 years old, is a self-report numerical scale ranging from 0, that means No pain, to 10, that means worst pain. | Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent's state and trait anxiety | Self-report scale (State-Trait Anxiety Inventory - STAI). The STAI is a self-report anxiety behavioral instrument for adults. It consists of two separate subscales: one assessing trait anxiety (baseline, Y1), the other assessing the state anxiety (situational, Y2). Each subscale is composed by 20 items, rated on a 4-points Likert scale and separately analyzed. Total score for each subscale range from 20 to 80, with higher scores denoting higher levels of anxiety. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, procedural, child, anxiety