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Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886314
First Posted: April 22, 2009
Last Update Posted: October 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  Purpose
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.

Condition Intervention
Insomnia Drug: midazolam Other: clown doctor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Preoperative anxiety [ Time Frame: Prior to induction of anesthesia ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: midazolam 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.
Active Comparator: clown doctor 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886314


Contacts
Contact: Yaacov Gozal, MD 972-2-6555 614 gozaly@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

Responsible Party: Yaacov Gozal, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00886314     History of Changes
Other Study ID Numbers: 12345
First Submitted: February 17, 2009
First Posted: April 22, 2009
Last Update Posted: October 20, 2009
Last Verified: February 2009

Keywords provided by Shaare Zedek Medical Center:
children
surgery
anxiety

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action