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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Soroka University Medical Center

Current Primary Outcome: 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: Children: VAS (Visual Analog Scale) [ Time Frame: 24 hours ]

measure at 3 time points (repeated measures) - at discharge, 12 and 24 hours.


Current Secondary Outcome:

  • 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: Same as current

Information By: Soroka University Medical Center

Dates:
Date Received: May 30, 2012
Date Started: August 2012
Date Completion: December 2015
Last Updated: November 30, 2014
Last Verified: November 2014