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

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ClinicalTrials.gov Identifier: NCT03899766
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Vagnoli, Meyer Children's Hospital

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.


Condition or disease Intervention/treatment
Venipuncture Other: Animal Assisted Intervention Other: Clowns Other: Musicians

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.


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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Animal Assisted Activity, Clowns and Music for the Reduction of Distress and Pain in Children During Venipuncture
Actual Study Start Date : February 12, 2016
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Animal Assisted Intervention
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
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.

Clowns
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
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.

Musicians
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
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.

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



Primary Outcome Measures :
  1. Distress [ Time Frame: 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. . ]
    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.

  2. Pain perception 3-6 years old [ Time Frame: Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment ]
    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".

  3. Pain perception from 7 years old [ Time Frame: Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment ]
    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".


Secondary Outcome Measures :
  1. Parent's state and trait anxiety [ Time Frame: 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 ]
    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.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatiens reffering to hospital for venipuncture
Criteria

Inclusion Criteria:

  • outpatients
  • scheduled to venipuncture
  • Italian speaking

Exclusion Criteria:

  • cognitive and/or developmental impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899766


Locations
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Italy
Meyer Children's Hospital
Firenze, Italy, 50139
Sponsors and Collaborators
Meyer Children's Hospital
Investigators
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Study Director: Andrea Messeri, MD Meyer Children's Hospital
Principal Investigator: Laura Vagnoli, MSc Meyer Children's Hospital

Publications:
Kaminsky M. (2002). Play and Pets: The Physical and Emotional Impact of Child-Life and Pet Theraphy on Hospitalized Children. Children's Health Care, 31(4), 321-335.

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Responsible Party: Laura Vagnoli, Principal Investigator, Meyer Children's Hospital
ClinicalTrials.gov Identifier: NCT03899766     History of Changes
Other Study ID Numbers: SupportActivities_Venipuncture
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Decision has to be shared with the Clinical Trial Office of the Hospital

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Vagnoli, Meyer Children's Hospital:
pain, procedural
child
anxiety