NCT00886314

Brief Summary

The purpose of the present investigation will be to determine whether a combination of clown doctor and parental presence is more effective than a combination of sedative premedication and parental presence for reducing anxiety in children and their parents and for improving parental satisfaction.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

October 20, 2009

Status Verified

February 1, 2009

Enrollment Period

3 months

First QC Date

February 17, 2009

Last Update Submit

October 18, 2009

Conditions

Insomnia

Keywords

childrensurgeryanxiety

Outcome Measures

Primary Outcomes (1)

  • Preoperative anxiety

    Prior to induction of anesthesia

Study Arms (2)

midazolam

ACTIVE COMPARATOR
Drug: midazolam

clown doctor

ACTIVE COMPARATOR
Other: clown doctor

Interventions

midazolamDRUG

Children in this group will be premedicated with oral midazolam syrup (0.3 mg.kg) at least 15 minutes before the surgical procedure and one of the parents will be present throughout the anesthesia induction process.

midazolam
clown doctorOTHER

Children will interact with clowns before entering the operating room and will stay with them and one of the parents throughout the anesthesia induction process.

clown doctor

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study.

You may not qualify if:

  • Children with prematurity, development delay, previous anesthetic experience will be excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yaacov Gozal, MD

    Shaare Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaacov Gozal, MD

CONTACT

972-2-6555 614gozaly@szmc.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

April 22, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2009

Last Updated

October 20, 2009

Record last verified: 2009-02

Locations

IL(1)