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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01758133
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01758133     History of Changes
Other Study ID Numbers: 006612-HYMC
Study First Received: December 24, 2012
Last Updated: December 24, 2012
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on August 21, 2014