Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

NCT ID: NCT00886314

Last Updated: 2009-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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midazolam

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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.

clown doctor

Group Type ACTIVE_COMPARATOR

clown doctor

Intervention Type OTHER

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.

Interventions

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midazolam

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.

Intervention Type DRUG

clown doctor

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Children with prematurity, development delay, previous anesthetic experience will be excluded from this study
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center

Principal Investigators

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Yaacov Gozal, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yaacov Gozal, MD

Role: CONTACT

972-2-6555 614

Other Identifiers

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12345

Identifier Type: -

Identifier Source: org_study_id

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