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NCT01758133 Clinical Trial

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

Breast Milk Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01758133
Other study ID # 006612-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 24, 2012
Last updated December 24, 2012
Start date January 2013
Est. completion date July 2013

Study information
Verified date December 2012
Source Hillel Yaffe Medical Center
Contact Ramit Magen-Rimon, MD
Phone 972-54-3064660
Email ramit.magen@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Nursing mothers of infants born less than 34th week

Exclusion Criteria:

- Sick mothers

- Take medication forbidden during nursing

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exposure to medical clown activities

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of breast milk produced 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 No
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