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

Self Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632888
• Other study ID #: 5762-GOA
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: February 2022
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hypothesis; H1: Telephone support for breastfeeding follow-up affects the development of physiological jaundice.

H2: Telephone support for breastfeeding monitoring affects exclusive breastfeeding for the first six months.

H3: Telephone support for breastfeeding follow-up affects infantile colic. H4: Telephone support for breastfeeding follow-up affects maternal breastfeeding self-efficacy.

H5: Telephone support for breastfeeding follow-up affects breastfeeding success of mothers.

Social media communication is planned to be completed at the 36th or older gestational week, who will have her first or second birth.

Block randomization will be applied according to maternal age, the number of births, baby gender, and birth week. Age (3 groups) X number of births (2 groups) X baby gender (2 groups) X gestational week (2 groups) = 24 blocks

Through social media, women between the ages of 18-45, who will have their first or second birth at their 36th or older gestational week will be included in the study. The woman in the control and study groups will be given breastfeeding and baby care training with the help of the training booklet by video calling.

• A socio-demographic data collection form will be filled, and the LATCH Breastfeeding Diagnostic Scale will be applied to the woman in the control and study groups on the day the mother gives birth, by making a video call by phone during breastfeeding.

• The women in the study group will be provided with a video call every day for the first week after their 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.

• No additional intervention 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.

• In the following weeks, the consultancy will continue to be given to the working group by making a video talk one week apart. The control group will be called to fill in the scales for monitoring purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refusal to participate in the study

• Failure to continue monitoring by phone

• Mother's illiteracy

• Development of pathological jaundice in the baby

Related Conditions & MeSH terms

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

Intervention

Other:
• Telephone support for breastfeeding follow-up
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

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	rate of physiological jaundice	physiological parameter of jaundice	until discharge from the hospital an average 2 week
Primary	rate of exclusive breastfeeding	exclusive breastfeeding for 6 months	until discharge from the hospital an average 24 week