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Procedural Pain in Children: Intervention With the Hospital Clown

Primary Purpose

Pain, Acute, Venous Puncture, Children, Adult

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hospital clown
No hospital clown intervention
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute focused on measuring Pain assessment, Self report, Hospital clown intervention

Eligibility Criteria

4 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Acutely admitted to the hospital
  • Scheduled for the venipuncture procedure
  • Not prepared for the procedure before coming to the hospital
  • Accompanied by at least one parent

Exclusion Criteria:

  • Subjects with developmental disorders who could not cooperate with self- reporting of pain
  • Subjects who were unable to speak Danish or English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Hospital clown intervention

    No hospital clown intervention

    Arm Description

    The performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure. The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel.

    The clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques.

    Outcomes

    Primary Outcome Measures

    Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
    Self-reported pain measure conducted after finishing the venipuncture in the examining room

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2017
    Last Updated
    December 7, 2017
    Sponsor
    Aalborg University Hospital
    Collaborators
    Aalborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03366623
    Brief Title
    Procedural Pain in Children: Intervention With the Hospital Clown
    Official Title
    Hospitalized Children's Pain Experience. Effect and Influence of Intervention With the Hospital Clown in Acute and Repeated Painful Procedures. A Mixed Method Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 18, 2016 (Actual)
    Primary Completion Date
    January 18, 2017 (Actual)
    Study Completion Date
    January 18, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aalborg University Hospital
    Collaborators
    Aalborg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.
    Detailed Description
    Background: Hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. These experiences can be traumatic for children and their families. Most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. Previous negative pain experiences are known to have major consequences for future admissions and procedures. Therefore, there is a need for different interventions for pain relief. In 2004, hospital clowns became a part of the team on pediatric wards in Denmark. International studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures. The overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care. Methods: A two-faced mixed methods study design with merging and connecting results and findings. A prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture. An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization. An ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Venous Puncture, Children, Adult
    Keywords
    Pain assessment, Self report, Hospital clown intervention

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    111 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hospital clown intervention
    Arm Type
    Other
    Arm Description
    The performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure. The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel.
    Arm Title
    No hospital clown intervention
    Arm Type
    Other
    Arm Description
    The clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hospital clown
    Intervention Description
    Presence of the hospital clown
    Intervention Type
    Behavioral
    Intervention Name(s)
    No hospital clown intervention
    Intervention Description
    Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.
    Primary Outcome Measure Information:
    Title
    Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
    Description
    Self-reported pain measure conducted after finishing the venipuncture in the examining room
    Time Frame
    During a time interval of between 0-5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Acutely admitted to the hospital Scheduled for the venipuncture procedure Not prepared for the procedure before coming to the hospital Accompanied by at least one parent Exclusion Criteria: Subjects with developmental disorders who could not cooperate with self- reporting of pain Subjects who were unable to speak Danish or English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helle N Kristensen
    Organizational Affiliation
    Aalborg University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Procedural Pain in Children: Intervention With the Hospital Clown

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