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.

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Key information

Conditions

Umbilical Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Inguinal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medical Center, Beersheba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Medical Clown

Behavioral

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 outcomes

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.

Secondary outcomes

Use of analgesics

Time frame: During the 24 hours following the surgery

Total dose of analgesics over 24 periods per kg.
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)

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Jun 19, 2012
Registry last updated: Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed