InsomniaNCT00886314
Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery
A study testing midazolam and clown doctor in people with Insomnia, run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Insomnia
- What is being tested?
- midazolam and clown doctor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study.
Who cannot join
- Children with prematurity, development delay, previous anesthetic experience will be excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
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.
clown doctorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Active comparator | Not described Receives: Drug: midazolam |
| clown doctor | Active comparator | Not described Receives: Other: clown doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety
Measured: Prior to induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yaacov Gozal, MD, Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886314
- Sponsor's protocol ID
- 12345
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery
- ClinicalTrials.gov ID
- NCT00886314
- Acronym / sponsor ID
- 12345
- Conditions
- Insomnia
- Keywords
- children, surgery, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (estimated)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam | Active comparator | Drug: midazolam |
| clown doctor | Active comparator | Other: clown doctor |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study.
Key exclusion criteria (1 listed)
- Children with prematurity, development delay, previous anesthetic experience will be excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolamChildren 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. | Drug | midazolam |
| clown doctorChildren will interact with clowns before entering the operating room and will stay with them and one of the parents throughout the anesthesia induction process. | Other | clown doctor |
Primary outcome
Preoperative anxiety
Time frame: Prior to induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaacov Gozal, MD principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam and clown doctor in people with Insomnia, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaacov Gozal, MD (972-2-6555 614, gozaly@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety (time frame: Prior to induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.