The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
Not Applicable
Completed
- Conditions
- Inguinal HerniaUmbilical Hernia
- Interventions
- Behavioral: Medical Clown
- Registration Number
- NCT01622218
- Lead Sponsor
- Soroka University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- ages 4-10 years old
- undergoing elective umbilical or inguinal hernia repair surgery
- ASA Physical Status = 1
Exclusion Criteria
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medical Clown 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Use of analgesics During the 24 hours following the surgery Total dose of analgesics over 24 periods per kg.
Trial Locations
- Locations (2)
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Assuta Medical Center
🇮🇱Beer Sheva, Israel