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Clown Care for Botulinum Toxin (BTX)

Primary Purpose

Cerebral Palsy, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standard
clown care
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Needle, Anxiety, Pain, Clowns

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with CP for whom BTX treatment was indicated

Exclusion Criteria:

  • Children with minimal communication skills (n =1)
  • Autistic spectrum disorders (n =1)
  • Severe anxiety requiring general anesthesia (n =1)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Standard intervention

    clown care

    Arm Description

    Preparation and information: the doctor and nurse explained the steps of the procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Memory change and positive reinforcement: medical staff present spoke to the child positively and offered prizes, among which the child could choose. Volunteer attendance: as part of the control session, receiving no particular instructions in relation to the child's potential pain during the procedure.

    Cognitive coping: encouraging a child to cope with the challenge. Imagery: a cognitive technique used to encourage the child to cope with the pain and distress of the procedure by imagining a pleasant object or experience Empowerment: the child is made to feel empowered by controlling the actions of the clown Reflecting emotions: the clown, sensing the state of the child, plays it out in an exaggerated fashion.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale
    Visual Analogue Scale by the child before after BTX injection. Parent rated the pain if the child was younger than 5 years or cognitively impaired

    Secondary Outcome Measures

    Full Information

    First Posted
    June 19, 2011
    Last Updated
    December 27, 2018
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01377883
    Brief Title
    Clown Care for Botulinum Toxin (BTX)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.
    Detailed Description
    PATIENTS AND METHODS: Twenty five children with CP (mean age 7.4±4.8 years; 19 boys), enrolled in this randomized controlled study underwent BTX injections (3±1.7 muscles per procedure). Prior to treatment each child was assigned to receive either medical clown intervention (study) or standard care (control). Outcome measure was the Visual Analogue Scale (VAS) as reported by the child (n =14) or parent (n =11) prior and subsequent to each procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Pain
    Keywords
    Needle, Anxiety, Pain, Clowns

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Standard intervention
    Arm Type
    Sham Comparator
    Arm Description
    Preparation and information: the doctor and nurse explained the steps of the procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Memory change and positive reinforcement: medical staff present spoke to the child positively and offered prizes, among which the child could choose. Volunteer attendance: as part of the control session, receiving no particular instructions in relation to the child's potential pain during the procedure.
    Arm Title
    clown care
    Arm Type
    Experimental
    Arm Description
    Cognitive coping: encouraging a child to cope with the challenge. Imagery: a cognitive technique used to encourage the child to cope with the pain and distress of the procedure by imagining a pleasant object or experience Empowerment: the child is made to feel empowered by controlling the actions of the clown Reflecting emotions: the clown, sensing the state of the child, plays it out in an exaggerated fashion.
    Intervention Type
    Other
    Intervention Name(s)
    standard
    Intervention Description
    Preparation and information regarding the BTX procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Injection performed under EMG guidance. Two sites of injection per muscle were used to enhance diffusion. The child could often see the procedure when the upper limb was treated but not during lower limb injections. Memory change and positive reinforcement: Following the BTX injection, the medical staff present spoke to the child positively and offered prizes Volunteer attendance: In the daycare unit there are young volunteers routinely present, assisting with technical aspects of the procedure.
    Intervention Type
    Behavioral
    Intervention Name(s)
    clown care
    Intervention Description
    Cognitive coping Imagery Empowerment Reflecting emotions
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    Visual Analogue Scale by the child before after BTX injection. Parent rated the pain if the child was younger than 5 years or cognitively impaired
    Time Frame
    sevral minutes before and after BTX injections

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children with CP for whom BTX treatment was indicated Exclusion Criteria: Children with minimal communication skills (n =1) Autistic spectrum disorders (n =1) Severe anxiety requiring general anesthesia (n =1)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28414728
    Citation
    Ben-Pazi H, Cohen A, Kroyzer N, Lotem-Ophir R, Shvili Y, Winter G, Deutsch L, Pollak Y. Clown-care reduces pain in children with cerebral palsy undergoing recurrent botulinum toxin injections- A quasi-randomized controlled crossover study. PLoS One. 2017 Apr 17;12(4):e0175028. doi: 10.1371/journal.pone.0175028. eCollection 2017.
    Results Reference
    derived

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    Clown Care for Botulinum Toxin (BTX)

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