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Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00886314
Enrollment
80
Registered
2009-04-22
Start date
2009-06-30
Completion date
Unknown
Last updated
2009-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

children, surgery, anxiety

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.

Interventions

DRUGmidazolam

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.

OTHERclown 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.

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Preoperative anxietyPrior to induction of anesthesia

Countries

Israel

Contacts

Primary ContactYaacov Gozal, MD
gozaly@szmc.org.il972-2-6555 614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026