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NCT00886314 Clinical Trial

Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

Insomnia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00886314
Other study ID # 12345
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 17, 2009
Last updated October 18, 2009
Start date June 2009

Study information
Verified date February 2009
Source Shaare Zedek Medical Center
Contact Yaacov Gozal, MD
Phone 972-2-6555 614
Email gozaly@szmc.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 12 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preoperative anxiety Prior to induction of anesthesia No
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