Skip to main content
Clinical Trials/NCT00609960
NCT00609960
Completed
Not Applicable

Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial

Sheba Medical Center1 site in 1 country65 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
midazolam
Conditions
Pre Operative Anxiety
Sponsor
Sheba Medical Center
Enrollment
65
Locations
1
Primary Endpoint
anxiety level
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
January 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • ASA I and II
  • Children aged 2-8 years

Exclusion Criteria

  • Previous surgery
  • ASA \> II
  • Parents' refusal

Arms & Interventions

2

midazolam a anxiolytic drug was given in the preoperative phase

Intervention: midazolam

3

clowns where present during the preoperative phase

Intervention: clowns present

Outcomes

Primary Outcomes

anxiety level

Time Frame: waiting area and enterance to OR -1 hour

Study Sites (1)

Loading locations...

Similar Trials