NCT00609960

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
Last Updated

February 7, 2008

Status Verified

January 1, 2008

Enrollment Period

1 year

First QC Date

January 24, 2008

Last Update Submit

February 6, 2008

Conditions

Pre Operative Anxiety

Keywords

children anesthesia anxiety clowns

Outcome Measures

Primary Outcomes (1)

  • anxiety level

    waiting area and enterance to OR -1 hour

Study Arms (3)

1

NO INTERVENTION

no medication or clowns present during the preopertaive phase

2

ACTIVE COMPARATOR

midazolam a anxiolytic drug was given in the preoperative phase

Drug: midazolam

3

ACTIVE COMPARATOR

clowns where present during the preoperative phase

Behavioral: clowns present

Interventions

clowns presentBEHAVIORAL

clowns present during the proccess of induction of anesthesia

3
midazolamDRUG

midazolam

2

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Ramat Gan, 52621, Israel

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ilan Keidan, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

February 7, 2008

Record last verified: 2008-01

Locations

IL(1)