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

February 6, 2008 updated by: Sheba Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Ramat Gan
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous surgery
  • ASA > II
  • Parents' refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
no medication or clowns present during the preopertaive phase
Active Comparator: 2
midazolam a anxiolytic drug was given in the preoperative phase
Drug: midazolam
midazolam
Active Comparator: 3
clowns where present during the preoperative phase
Behavioral: clowns present
clowns present during the proccess of induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anxiety level
Time Frame: waiting area and enterance to OR -1 hour
waiting area and enterance to OR -1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Ilan Keidan, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 7, 2008

Last Update Submitted That Met QC Criteria

February 6, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-05-3739-IK-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pre Operative Anxiety

Clinical Trials on midazolam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe