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

November 9, 2020 updated by: Nitza Heiman Newman, MD, Soroka University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Beer Sheva, Israel
        • Assuta Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of analgesics
Time Frame: During the 24 hours following the surgery
Total dose of analgesics over 24 periods per kg.
During the 24 hours following the surgery
Cytokines levels
Time Frame: 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)
End of precedure, before waking up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor007112clit

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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