Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
- Preoperative anxiety [ Time Frame: Prior to induction of anesthesia ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886314
|Contact: Yaacov Gozal, MD||972-2-6555 email@example.com|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Yaacov Gozal, MD||Shaare Zedek Medical Center, Jerusalem, Israel|