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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00609960 |
This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use
Condition | Intervention |
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Pre Operative Anxiety |
Behavioral: clowns present Drug: midazolam |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Caregiver), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial |
Enrollment: | 65 |
Study Start Date: | January 2006 |
Study Completion Date: | January 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
no medication or clowns present during the preopertaive phase
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2: Active Comparator
midazolam a anxiolytic drug was given in the preoperative phase
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Drug: midazolam
midazolam
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3: Active Comparator
clowns where present during the preoperative phase
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Behavioral: clowns present
clowns present during the proccess of induction of anesthesia
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The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children.
Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction.
Ages Eligible for Study: | 2 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sheba Medical Center ( Ilan Keidan MD, Director pediatric anesthesia ) |
Study ID Numbers: | SHEBA-05-3739-IK-CTIL |
Study First Received: | January 24, 2008 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00609960 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
children anesthesia anxiety clowns |
Midazolam |
Anesthetics, Intravenous Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Anesthetics |
Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |