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

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01622218
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Actual Duration (Months): 76
• Patients Per Site: 25
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Umbilical Hernia; Inguinal Hernia	Behavioral: Medical Clown	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Use of analgesics [During the 24 hours following the surgery]

   Total dose of analgesics over 24 periods per kg.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ages 4-10 years old

• undergoing elective umbilical or inguinal hernia repair surgery

• ASA Physical Status = 1

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soroka University Medical Center	Beer Sheva		Israel	84101
2	Assuta Medical Center	Beer Sheva		Israel

Sponsors and Collaborators

• Soroka University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nitza Heiman Newman, MD, Principle Investigator, Soroka University Medical Center
• ClinicalTrials.gov Identifier: NCT01622218
• Other Study ID Numbers: sor007112clit
• First Posted: Jun 19, 2012
• Last Update Posted: Nov 12, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Nitza Heiman Newman, MD, Principle Investigator, Soroka University Medical Center: Medical clown
• Additional relevant MeSH terms: Hernia, Umbilical; Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Nov 12, 2020