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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

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.

Condition or disease Intervention/treatment Phase
Umbilical Hernia Inguinal Hernia Behavioral: Medical Clown Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study
Study Start Date : August 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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.
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

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Use of analgesics [ Time Frame: During the 24 hours following the surgery ]
    Total dose of analgesics over 24 periods per kg.

  2. 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)



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622218


Locations
Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact: Gal Sigelnik, MHA    +972-86244245      
Assuta Medical Center Recruiting
Beer Sheva, Israel
Contact: Gal Sigelnik, MHA    972-8-6244245      
Sponsors and Collaborators
Soroka University Medical Center

Responsible Party: Nitza Heiman Newman, MD, Principle Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01622218     History of Changes
Other Study ID Numbers: sor007112clit
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Nitza Heiman Newman, MD, Soroka University Medical Center:
Medical clown

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Umbilical
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases
Hernia, Ventral
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs