Effect of Music on Breastmilk

NCT01893047 | Completed

• 2 other identifiers: 47585University of Rochester
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A mother of a preterm infant listening to music while pumping her breasts will produce more milk than a similar mother who is not listening to music. A mother listening to live music will produce more milk than a mother listening to recorded music

Conditions

Breast Milk Production

Keywords

breast milk production

Outcome Measures

Primary Outcomes (1)

• Volume of milk in ten minutes

  Milk volume in Ml.

  10 days

Secondary Outcomes (2)

• Milk sodium

  10 days

• Milk lipid

  10 days

Study Arms (3)

no music

NO INTERVENTION

The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order

live music

EXPERIMENTAL

The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order

Behavioral: live music

recorded music

EXPERIMENTAL

The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order

Behavioral: recorded music

Interventions

live music BEHAVIORAL

live harp music

live music

recorded music BEHAVIORAL

recorded harp music

recorded music

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• First time mothers between the ages of 18 and 45 who have had a vaginal or caesarean delivery and are feeling well.
• First time mothers are used to avoid confounding variables due to previous positive or negative experiences from expressing milk. Their infant will have been born at less than 32.0 weeks of gestation.
• Mothers will intend to breastfeed and are planning to pump milk on site in the NICU at least once/day and will be recruited 7-10 days postpartum.
• Mothers who smoke, are taking medication that may interfere with breastfeeding, and who have undergone prior breast surgery will not be excluded since they are their own control.
• With regard to language, mothers must be able to understand the directions and sign a consent form in English.

You may not qualify if:

• Mothers will not be recruited whose infant has a low likelihood of survival as determined by the attending physician.
• Mothers who have been diagnosed with mastitis will not be recruited for the study.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Officials

• Ruth Lawrence, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics, Neonatology

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)