- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758133
Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants
December 24, 2012 updated by: Hillel Yaffe Medical Center
The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ramit Magen-Rimon, MD
- Phone Number: 972-54-3064660
- Email: ramit.magen@gmail.com
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Mothers of premature infants
Description
Inclusion Criteria:
- Nursing mothers of infants born less than 34th week
Exclusion Criteria:
- Sick mothers
- Take medication forbidden during nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mothers exposed to medical clowns
Mothers of premature infants who have been exposed to medical clown activities
|
|
Mothers not exposed to medical clown activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of breast milk produced
Time Frame: One week
|
Mothers who have either been exposed or not exposed to medical clown activities will pump their breast milk.
The milk will be measured and the two groups production will be compared.
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
July 1, 2013
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
December 24, 2012
First Submitted That Met QC Criteria
December 24, 2012
First Posted (Estimate)
January 1, 2013
Study Record Updates
Last Update Posted (Estimate)
January 1, 2013
Last Update Submitted That Met QC Criteria
December 24, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 006612-HYMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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