CClinicalTrials.gg
Status unknownNCT00886314Updated Oct 20, 2009

Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

An interventional study of midazolam and clown doctor in Insomnia, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2009-10-20.

Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insomnia

Keywords

  • children
  • surgery
  • anxiety
03

In context

Lead sponsor

Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Children with prematurity, development delay, previous anesthetic experience will be excluded from this study
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    midazolam

    Drug: midazolam

  • Active comparator
    clown doctor

    Other: clown doctor

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.

06

What researchers measure

Primary outcomes

  1. Preoperative anxiety

    Time frame: Prior to induction of anesthesia

07

Study locations

1 site
  • Shaare Zedek Medical Center
    Jerusalem, 91031, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00886314
Lead sponsor
Shaare Zedek Medical Center
First posted
Apr 22, 2009
Start date
Jun 2009
Primary completion
Sep 2009 (estimated)
Last update
Oct 20, 2009

Study contacts

Yaacov Gozal, MD
Contact
gozaly@szmc.org.il
972-2-6555 614
Yaacov Gozal, MD
principal investigator · Shaare Zedek Medical Center, Jerusalem, Israel
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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