NCT01758133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 1, 2013

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

December 24, 2012

Last Update Submit

December 24, 2012

Conditions

Breast Milk

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Interventions

Exposure to medical clown activitiesBEHAVIORAL
Mothers exposed to medical clowns

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Mothers of premature infants

You may qualify if:

  • Nursing mothers of infants born less than 34th week

You may not qualify if:

  • Sick mothers
  • Take medication forbidden during nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Central Study Contacts

Ramit Magen-Rimon, MD

CONTACT

972-54-3064660ramit.magen@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 1, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 1, 2013

Record last verified: 2012-12

Locations

IL(1)