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Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01758133
Recruitment Status : Unknown
Verified December 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Milk Behavioral: Exposure to medical clown activities

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : January 2013
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013
Groups and Cohorts

Group/Cohort Intervention/treatment
Mothers exposed to medical clowns
Mothers of premature infants who have been exposed to medical clown activities
Behavioral: Exposure to medical clown activities
Mothers not exposed to medical clown activity


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Mothers of premature infants
Criteria

Inclusion Criteria:

  • Nursing mothers of infants born less than 34th week

Exclusion Criteria:

  • Sick mothers
  • Take medication forbidden during nursing
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758133


Contacts
Contact: Ramit Magen-Rimon, MD 972-54-3064660 ramit.magen@gmail.com

Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01758133     History of Changes
Other Study ID Numbers: 006612-HYMC
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: January 1, 2013
Last Verified: December 2012