An interventional study of clowns present and midazolam in Pre Operative Anxiety, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2008-02-07.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Supportive care
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
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 65 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
no medication or clowns present during the preopertaive phase
midazolam a anxiolytic drug was given in the preoperative phase
Drug: midazolam
clowns where present during the preoperative phase
Behavioral: clowns present
clowns present during the proccess of induction of anesthesia
midazolam
anxiety level
Time frame: waiting area and enterance to OR -1 hour
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center