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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

Tracking Information
First Submitted Date December 24, 2018
First Posted Date April 2, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date February 12, 2016
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2019)
  • 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.
  • 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".
  • 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".
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03899766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 1, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Outpatiens reffering to hospital for venipuncture
Condition Venipuncture
Intervention
  • 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.
  • 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.
  • 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.
Study Groups/Cohorts
  • 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
    Intervention: Other: Animal Assisted Intervention
  • 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
    Intervention: Other: Clowns
  • 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
    Intervention: Other: Musicians
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 1, 2019)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • outpatients
  • scheduled to venipuncture
  • Italian speaking

Exclusion Criteria:

  • cognitive and/or developmental impairment
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03899766
Other Study ID Numbers SupportActivities_Venipuncture
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Decision has to be shared with the Clinical Trial Office of the Hospital
Responsible Party Laura Vagnoli, Meyer Children's Hospital
Study Sponsor Meyer Children's Hospital
Collaborators Not Provided
Investigators
Study Director: Andrea Messeri, MD Meyer Children's Hospital
Principal Investigator: Laura Vagnoli, MSc Meyer Children's Hospital
PRS Account Meyer Children's Hospital
Verification Date July 2019