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

Not Applicable

Completed

• Conditions: Inguinal Hernia; Umbilical Hernia

• Registration Number: NCT01622218
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Study Start: 2012-08
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Children: WBS (Wong Baker Faces Pain Rating Scale)	24 hours	measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.

Secondary Outcome Measures

Name	Time	Method
Cytokines levels	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)
Use of analgesics	During the 24 hours following the surgery	Total dose of analgesics over 24 periods per kg.

Trial Locations

Locations (2)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel

Assuta Medical Center; 🇮🇱 Beer Sheva, Israel