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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01622218
Other study ID # sor007112clit
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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