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Clinical Trials/NCT01622218
NCT01622218
Completed
N/A

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

Soroka University Medical Center2 sites in 1 country50 target enrollmentAugust 2012
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ConditionsUmbilical HerniaInguinal Hernia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Umbilical Hernia
Sponsor
Soroka University Medical Center
Enrollment
50
Locations
2
Primary Endpoint
Children: WBS (Wong Baker Faces Pain Rating Scale)
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nitza Heiman Newman, MD

Principle Investigator

Soroka University Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Cytokines levels(End of precedure, before waking up)
  • Use of analgesics(During the 24 hours following the surgery)

Study Sites (2)

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