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

Primary Purpose

Breastfeeding, Exclusive, Infantile Colic, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telephone support for breastfeeding follow-up
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding, Exclusive

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Gülçin Özalp Gerçeker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group/Telephone support for breastfeeding follow-up

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
rate of physiological jaundice
physiological parameter of jaundice
rate of exclusive breastfeeding
exclusive breastfeeding for 6 months

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
February 9, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04632888
Brief Title
The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Exclusive, Infantile Colic, Self Efficacy, Jaundice, Neonatal

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised, parallel trial design
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group/Telephone support for breastfeeding follow-up
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telephone support for breastfeeding follow-up
Intervention Description
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
Primary Outcome Measure Information:
Title
breastfeeding success
Description
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.
Time Frame
until discharge from the hospital an average 2 week
Title
Infantile Colic
Description
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.
Time Frame
until discharge from the hospital an average 24 week
Title
Maternal Breastfeeding Self-Efficacy
Description
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.
Time Frame
until discharge from the hospital an average 24 week
Title
rate of physiological jaundice
Description
physiological parameter of jaundice
Time Frame
until discharge from the hospital an average 2 week
Title
rate of exclusive breastfeeding
Description
exclusive breastfeeding for 6 months
Time Frame
until discharge from the hospital an average 24 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The mothers with babies
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker
Organizational Affiliation
RN, PhD, Assoc. Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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