NCT05059028

Brief Summary

The aim of this study is to examine the effect of oxytocin massage and music performed immediately after birth on breastfeeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

September 13, 2021

Last Update Submit

August 4, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Diagnostic and Evaluation Scale

    LATCH is a breastfeeding charting system that provides a systematic method for gathering information about individual breastfeeding sessions. The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding. Each letter of the acronym LATCH denotes an area of assessment. "L" is for how well the infant latches onto the breast. "A" is for the amount of audible swallowing noted. "T" is for the mother's nipple type. "C" is for the mother's level of comfort. "H" is for the amount of help the mother needs to hold her infant to the breast. The minimum point is 0 and maximum point is 10. The highest 10 points to be obtained from the scale are taken, and a high score indicates good breastfeeding success.

    1 month

  • Breastfeeding Self-Efficacy Scale short form

    The questionnaire is a 14-item self-administered instrument derived from the original 33-items, that measures breastfeeding confidence. All items are preceded on a 5-point Likert scale, ranging from 1 to 5. Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.

    1 month

  • Infant Nutrition Attitude Scale

    The scale is composed of 17 items with a 5-point Likert scale ranging from 1 to 5. The total IIFAS score can range from 17 to 85 with higher scores reflecting positive attitude towards breastfeeding. Total IIFAS scores can be further categorized into groups: 1) positive to breastfeeding (IIFAS score 70-85), 2) neutral (IIFAS score 49-69), and 3) positive to formula feeding (IIFAS score 17-48).

    1 month

Study Arms (3)

Oxytocin massage

ACTIVE COMPARATOR
Other: Oxytocin massage AND music therapy

music therapy

ACTIVE COMPARATOR
Other: Oxytocin massage AND music therapy

control group

NO INTERVENTION

Interventions

Oxytocin massage: It is a massage that will accelerate the work of the parasympathetic nerves in order to transmit the oxytocin production stimulus to the posterior lobe of the brain. Massage the scapula from the cervical 7th to the 5th-6th spine, spinal (vertebral), 1-2 cm around the spine, both thumbs up and then 2-3 times down, in a small circular clockwise, downward and upward movements. It is a form of massage by pressing hard. Music intervention: In order to decide on the type of music to be played to the mothers during breastfeeding, three samples (Pentatonic, Büzürk makam and classical music) selected by the researcher will be asked to the postpartum mother, and the music preferred by the mothers will be determined. It will be ensured that mothers listen to the music determined 5 minutes before the breastfeeding session for 7 days and continue breastfeeding while the same music is playing.

Oxytocin massagemusic therapy

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mothers who are 20 years or older,
  • Primiparous delivery,
  • Single fetus pregnancy,
  • Born at term (38-42 weeks of gestation),
  • Your baby's Apgar score is at least 8 points in the 5th minute,
  • Being literate,
  • Interviewed on the first day after birth,
  • Does not have a problem that prevents breastfeeding,
  • No complications during and after birth,
  • Staying in the same room with her baby after birth,
  • There is no health problem that may affect the baby's suckling,
  • Those who become pregnant by normal means (without IVF, IVF, etc.),
  • Babies with a birth weight of more than 2500,
  • Mothers without chronic disease,
  • Non-smoking mothers,
  • +1 more criteria

You may not qualify if:

  • The mother/baby has a serious health problem that prevents breastfeeding,
  • Absence from education for at least two sessions,
  • Women with a known disease (HIV, hepatitis B, hepatitis C, etc.) known to be transmitted through breast milk will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Other, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 28, 2021

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

July 30, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations