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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yaacov Gozal, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00886314     History of Changes
Other Study ID Numbers: 12345
Study First Received: February 17, 2009
Last Updated: October 18, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
children
surgery
anxiety

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

ClinicalTrials.gov processed this record on October 21, 2014