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

NCT ID: NCT00609960

Last Updated: 2008-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-01-31

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.

Conditions

Pre Operative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

1

no medication or clowns present during the preopertaive phase

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

midazolam a anxiolytic drug was given in the preoperative phase

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

midazolam

3

clowns where present during the preoperative phase

Group Type: ACTIVE_COMPARATOR

clowns present

Intervention Type: BEHAVIORAL

clowns present during the proccess of induction of anesthesia

Interventions

clowns present

clowns present during the proccess of induction of anesthesia

Intervention Type: BEHAVIORAL

midazolam

midazolam

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Previous surgery
• ASA > II
• Parents' refusal

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sheba Medical Center

Principal Investigators

Ilan Keidan, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, Ramat Gan, Israel

Countries

Israel

Other Identifiers

SHEBA-05-3739-IK-CTIL

Identifier Type: -

Identifier Source: org_study_id