The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 12, 2020
November 1, 2020
6.3 years
May 30, 2012
November 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Children: WBS (Wong Baker Faces Pain Rating Scale)
measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.
24 hours
Secondary Outcomes (2)
Use of analgesics
During the 24 hours following the surgery
Cytokines levels
End of precedure, before waking up
Study Arms (2)
Medical Clown
EXPERIMENTALPresence 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.
Control
NO INTERVENTIONAssessment 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- ages 4-10 years old
- undergoing elective umbilical or inguinal hernia repair surgery
- ASA Physical Status = 1
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Soroka University Medical Center
Beersheba, 84101, Israel
Assuta Medical Center
Beersheba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 19, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
November 12, 2020
Record last verified: 2020-11