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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758133
First Posted: January 1, 2013
Last Update Posted: January 1, 2013
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.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose
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 Intervention
Breast Milk Behavioral: Exposure to medical clown activities

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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 Submitted: December 24, 2012
First Posted: January 1, 2013
Last Update Posted: January 1, 2013
Last Verified: December 2012