CClinicalTrials.gg
CompletedNCT04632888Updated Feb 25, 2022

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

An interventional study of Telephone support for breastfeeding follow-up in Breastfeeding, Exclusive, Infantile Colic and Self Efficacy, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Breastfeeding, Exclusive
  • Infantile Colic
  • Self Efficacy
  • Jaundice, Neonatal
03

In context

Colic

148 studies on the registry are indexed under Colic; 21 are open to participants now.

This study's enrollment of 70 is below the median of 88 across 122 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Refusal to participate in the study
  • Failure to continue monitoring by phone
  • Mother's illiteracy
  • Development of pathological jaundice in the baby
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Study group/Telephone support for breastfeeding follow-up

    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

  • No intervention
    Control Group

    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

  • OtherTelephone 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: until discharge from the hospital an average 2 week

  2. 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.

    Time frame: until discharge from the hospital an average 24 week

  3. 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.

    Time frame: until discharge from the hospital an average 24 week

  4. rate of physiological jaundice

    physiological parameter of jaundice

    Time frame: until discharge from the hospital an average 2 week

  5. rate of exclusive breastfeeding

    exclusive breastfeeding for 6 months

    Time frame: until discharge from the hospital an average 24 week

07

Study locations

1 site
  • Gülçin Özalp Gerçeker
    Izmir, 35100, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04632888
Lead sponsor
Dokuz Eylul University
Responsible party
Gülçin Özalp Gerçeker (Assoc. Prof., Dokuz Eylul University) — Principal investigator
First posted
Nov 17, 2020
Start date
Oct 14, 2020
Primary completion
May 30, 2021
Completion
May 30, 2021
Last update
Feb 25, 2022

Study contacts

Gülçin Özalp Gerçeker
principal investigator · RN, PhD, Assoc. Prof.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion