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

Primary Purpose

Umbilical Hernia, Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Medical Clown
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Umbilical Hernia focused on measuring Medical clown

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Soroka University Medical Center
  • Assuta Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medical Clown

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Use of analgesics
Total dose of analgesics over 24 periods per kg.
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-α and VEGF)

Full Information

First Posted
May 30, 2012
Last Updated
November 9, 2020
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01622218
Brief Title
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
Official Title
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia, Inguinal Hernia
Keywords
Medical clown

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Clown
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medical Clown
Intervention Description
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
Primary Outcome Measure Information:
Title
Children: WBS (Wong Baker Faces Pain Rating Scale)
Description
measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Use of analgesics
Description
Total dose of analgesics over 24 periods per kg.
Time Frame
During the 24 hours following the surgery
Title
Cytokines levels
Description
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)
Time Frame
End of precedure, before waking up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 4-10 years old undergoing elective umbilical or inguinal hernia repair surgery ASA Physical Status = 1 Exclusion Criteria: None
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Assuta Medical Center
City
Beer Sheva
Country
Israel

12. IPD Sharing Statement

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

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