An interventional study of Medical Clown in Umbilical Hernia and Inguinal Hernia, sponsored by Soroka University Medical Center. Completed at 2 sites in Israel. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Prevention
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Soroka University Medical Center is the lead sponsor of 160 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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.
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
Children: WBS (Wong Baker Faces Pain Rating Scale)
measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.
Time frame: 24 hours
Use of analgesics
Total dose of analgesics over 24 periods per kg.
Time frame: During the 24 hours following the surgery
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)
Time frame: End of precedure, before waking up
Ran from Aug 2012 to primary completion in Dec 2018, 76 months.
Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's 76 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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