- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04632888
The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey, 35100
- Gülçin Özalp Gerçeker
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
breastfeeding success
Time Frame: until discharge from the hospital an average 2 week
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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.
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until discharge from the hospital an average 2 week
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Infantile Colic
Time Frame: until discharge from the hospital an average 24 week
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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.
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until discharge from the hospital an average 24 week
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Maternal Breastfeeding Self-Efficacy
Time Frame: until discharge from the hospital an average 24 week
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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.
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until discharge from the hospital an average 24 week
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rate of physiological jaundice
Time Frame: until discharge from the hospital an average 2 week
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physiological parameter of jaundice
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until discharge from the hospital an average 2 week
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rate of exclusive breastfeeding
Time Frame: until discharge from the hospital an average 24 week
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exclusive breastfeeding for 6 months
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until discharge from the hospital an average 24 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülçin Özalp Gerçeker, RN, PhD, Assoc. Prof.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5762-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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