Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Shaare Zedek Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT00886314

First received: February 17, 2009

Last updated: October 18, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 17, 2009

Last Updated Date

October 18, 2009

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Preoperative anxiety [ Time Frame: Prior to induction of anesthesia ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00886314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

Official Title ^ICMJE

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Insomnia

Intervention ^ICMJE

Drug: 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.
Other: 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.

Study Arm (s)

Active Comparator: midazolam
Intervention: Drug: midazolam
Active Comparator: clown doctor
Intervention: Other: clown doctor

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yaacov Gozal, MD

972-2-6555 614

gozaly@szmc.org.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00886314

Other Study ID Numbers ^ICMJE

12345

Has Data Monitoring Committee

Responsible Party

Yaacov Gozal, MD, Shaare Zedek Medical Center

Study Sponsor ^ICMJE

Shaare Zedek Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yaacov Gozal, MD

Shaare Zedek Medical Center, Jerusalem, Israel

Information Provided By

Shaare Zedek Medical Center

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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