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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622218
• Other study ID #: sor007112clit
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2018

Study information

• Verified date: November 2020
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• ages 4-10 years old

• undergoing elective umbilical or inguinal hernia repair surgery

• ASA Physical Status = 1

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Umbilical
• Inguinal Hernia
• Umbilical Hernia

Intervention

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

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Beer Sheva
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children: WBS (Wong Baker Faces Pain Rating Scale)	measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.	24 hours
Secondary	Use of analgesics	Total dose of analgesics over 24 periods per kg.	During the 24 hours following the surgery
Secondary	Cytokines levels	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-a and VEGF)	End of precedure, before waking up