Breastfeeding, ExclusiveNCT04632888
The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy
A study testing Telephone support for breastfeeding follow-up in people with Breastfeeding, Exclusive and Infantile Colic, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Infantile Colic, Self Efficacy
- What is being tested?
- Telephone support for breastfeeding follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Refusal to participate in the study
- Failure to continue monitoring by phone
- Mother's illiteracy
- Development of pathological jaundice in the baby
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Telephone support for breastfeeding follow-up
- Medical subject headings
- Breast Feeding, Colic, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone support for breastfeeding follow-upOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: until discharge from the hospital an average 24 week
rate of physiological jaundice
physiological parameter of jaundice
Measured: until discharge from the hospital an average 2 week
rate of exclusive breastfeeding
exclusive breastfeeding for 6 months
Measured: until discharge from the hospital an average 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start14 Oct 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, parallel trial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, Principal investigator, RN, PhD, Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632888
- Sponsor's protocol ID
- 5762-GOA
- Status last verified
- Feb 2022
- First submitted
- 12 Nov 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39742561
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04632888
- Acronym / sponsor ID
- 5762-GOA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomised, parallel trial design
| Arm | Type | Receives |
|---|---|---|
| Study group/Telephone support for breastfeeding follow-up | Experimental | Other: Telephone support for breastfeeding follow-upStudy 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 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Failure to continue monitoring by phone
- Mother's illiteracy
- Development of pathological jaundice in the baby
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone support for breastfeeding follow-upThe 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 | Other | Study group/Telephone support for breastfeeding follow-up |
Primary outcome
breastfeeding success
Time frame: until discharge from the hospital an average 2 week
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
Time frame: until discharge from the hospital an average 24 week
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
Time frame: until discharge from the hospital an average 24 week
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
Time frame: until discharge from the hospital an average 2 week
physiological parameter of jaundice
rate of exclusive breastfeeding
Time frame: until discharge from the hospital an average 24 week
exclusive breastfeeding for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Derived from this study: PubMed 39742561Aykan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülçin Özalp Gerçeker principal investigator
RN, PhD, Assoc. Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone support for breastfeeding follow-up in people with Breastfeeding, Exclusive and Infantile Colic, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breastfeeding success (time frame: until discharge from the hospital an average 2 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.