Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial

Sheba Medical Center

Status: Completed

Conditions: Pre Operative Anxiety

Treatments: Drug: midazolam; Behavioral: clowns present

Study type: Interventional

Funder types: Other

Identifiers

NCT00609960

SHEBA-05-3739-IK-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous surgery
• ASA > II
• Parents' refusal

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

1

No Intervention group

Description:

no medication or clowns present during the preopertaive phase

2

Active Comparator group

Description:

midazolam a anxiolytic drug was given in the preoperative phase

Treatment:

Drug: midazolam

3

Active Comparator group

Description:

clowns where present during the preoperative phase

Treatment:

Behavioral: clowns present