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

This study is currently recruiting participants.
Verified September 2012 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Nitza Heiman Newman Dr., Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01622218
First received: May 30, 2012
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of our study to quantitatively examine the anxiety 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 Intervention
Umbilical Hernia
Inguinal Hernia
 Behavioral: Medical Clown

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of Medical Clowning on Pain and Anxiety Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Hernia
U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Children: VAS (Visual Analog Scale) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    measure at 3 time points (repeated measures) - at discharge, 12 and 24 hours.


Secondary Outcome Measures:
  • Use of analgesics [ Time Frame: During the 24 hours following the surgery ] [ Designated as safety issue: No ]
    Total dose of analgesics over 24 periods per kg.

  • Cytokines levels [ Time Frame: End of precedure, before waking up ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622218

Locations
Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact: Ayala Dvir, Msc     +972-86244245        
Sponsors and Collaborators
Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Nitza Heiman Newman Dr., Principle Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01622218     History of Changes
Other Study ID Numbers: sor007112clit
Study First Received: May 30, 2012
Last Updated: September 3, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013