The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy

NCT04632888 | Completed DMC

• 1 other identifier: 5762-GOA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to examine the effect of telephone support for breastfeeding follow-up on physiological jaundice, exclusive breastfeeding in the first six months, infantile colic, maternal breastfeeding self-efficacy, and breastfeeding success.

Conditions

Breastfeeding, Exclusive; Infantile Colic; Self Efficacy; Jaundice, Neonatal

Outcome Measures

Primary Outcomes (5)

• breastfeeding success

  LATCH Breastfeeding Assesment Scale: It is a measurement tool developed to evaluate breastfeeding. It was created to diagnose breastfeeding, to identify problems, to determine training accordingly, to create a common language among health professionals and to be used in studies. This measurement tool consists of the English initials of five evaluation criteria. Each item is scored between 0-2 points. The highest score is 10.

  until discharge from the hospital an average 2 week

• Infantile Colic

  Infantile Colic Scale: It was developed to diagnose and evaluate colic. The validity and reliability study of the scale was done in Turkey. 12 Scale items are graded with Likert type scoring ranging from 1 to 6.

  until discharge from the hospital an average 24 week

• Maternal Breastfeeding Self-Efficacy

  Breastfeeding Self-Efficacy Scale-Short Form: It is a 33-item scale to evaluate breastfeeding self-efficacy levels of mothers. Later, a 14-item short form of the scale was developed in 2003. It is applied more easily and evaluates self-efficacy correctly. Breastfeeding Self-Efficacy Short Form Scale is a 5 point Likert type scale.

  until discharge from the hospital an average 24 week

• rate of physiological jaundice

  physiological parameter of jaundice

  until discharge from the hospital an average 2 week

• rate of exclusive breastfeeding

  exclusive breastfeeding for 6 months

  until discharge from the hospital an average 24 week

Study Arms (2)

Study group/Telephone support for breastfeeding follow-up

EXPERIMENTAL

Study group: The women in the study group will be provided with a video call every day for the first week after discharge from the hospital, to provide consultancy to the mother on the matters she needs and to be recorded in the Baby Monitoring Form. The general appearance of the baby, observation during sucking, jaundice, drowsiness, reluctance to suck will be observed. The consultancy will be provided to the mother on these issues. In the following weeks, the consultancy will continue to be given to the study group by making a video talk one week apart. The researcher's phone will be given to the mothers in both groups and the incoming calls and their content will be recorded.

Other: Telephone support for breastfeeding follow-up

Control Group

NO INTERVENTION

Control Group: No additional attempt or routine call will be made to mothers in the control group. The researcher's phone will be given to the mothers in both groups and the incoming calls and their content will be recorded. The control group will be called to fill in the scales for monitoring purposes.

Interventions

Telephone support for breastfeeding follow-up OTHER

The researcher, after the mother is discharged, by making a video call by phone every day for the first week, providing counseling to the mother on matters that she needs and recording it in the Baby Monitoring Form The researcher gives the mother a video

Study group/Telephone support for breastfeeding follow-up

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The mothers with babies
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having / had a new birth between the ages of 18-45
• Having his 1st or 2nd birth
• Agreeing to participate in the study voluntarily and obtaining consent form
• Having given birth to a healthy baby above 36 weeks of gestation
• Planning to breastfeed
• The baby does not need intensive care and does not develop any postpartum complications
• The baby does not have a vision and hearing problem, does not have a disease that may prevent breastfeeding
• The baby does not have a physical and psychological deficit
• The baby does not have a disease or an anatomical problem that will prevent breastfeeding
• Mother's ability to continue monitoring on the phone and to have a phone that can provide monitoring and video chat.
• No blood incompatibility between mother and baby.

You may not qualify if:

• Refusal to participate in the study
• Failure to continue monitoring by phone
• Mother's illiteracy
• Development of pathological jaundice in the baby

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Aykan Z, Ozalp Gerceker G. The effect of telephone-assisted breastfeeding monitoring on physiological jaundice, exclusive breastfeeding in the first six months, development of colic, and breastfeeding self-efficacy: A randomized controlled trial. Infant Behav Dev. 2025 Mar;78:102023. doi: 10.1016/j.infbeh.2024.102023. Epub 2024 Dec 31.

  PMID: 39742561 DERIVED

MeSH Terms

Conditions

Breast Feeding; Colic; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülçin Özalp Gerçeker

  RN, PhD, Assoc. Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Prospective, randomised, parallel trial design

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 17, 2020
• Study Start: October 14, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

TU (1)