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The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.

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ClinicalTrials.gov Identifier: NCT01622218
Recruitment Status : Unknown
Verified November 2014 by Nitza Heiman Newman, MD, Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Nitza Heiman Newman, MD, Soroka University Medical Center

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE June 19, 2012
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2014)
Children: WBS (Wong Baker Faces Pain Rating Scale) [ Time Frame: 24 hours ]
measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
Children: VAS (Visual Analog Scale) [ Time Frame: 24 hours ]
measure at 3 time points (repeated measures) - at discharge, 12 and 24 hours.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
  • Use of analgesics [ Time Frame: During the 24 hours following the surgery ]
    Total dose of analgesics over 24 periods per kg.
  • Cytokines levels [ Time Frame: End of precedure, before waking up ]
    Cytokined levels at the end of the surgery (end of precedure, before waking up)(IL-1b, IL-2,IL-6, IL-8, IL-10,TNF-α and VEGF)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
Official Title  ICMJE The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study
Brief Summary The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Umbilical Hernia
  • Inguinal Hernia
Intervention  ICMJE Behavioral: Medical Clown
Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers
Study Arms  ICMJE
  • Experimental: Medical Clown
    Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers.
    Intervention: Behavioral: Medical Clown
  • No Intervention: Control
    Assessment of child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect on the total consumption of analgesics and on the post- surgery inflammatory markers.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ages 4-10 years old
  • undergoing elective umbilical or inguinal hernia repair surgery
  • ASA Physical Status = 1

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01622218
Other Study ID Numbers  ICMJE sor007112clit
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nitza Heiman Newman, MD, Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Soroka University Medical Center
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP