Clinical trial NCT04632888: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Infantile Colic
Self Efficacy
Jaundice, Neonatal
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, parallel trial design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: breastfeeding success
timeFrame: until discharge from the hospital an average 2 week
measure: Infantile Colic
timeFrame: until discharge from the hospital an average 24 week
measure: Maternal Breastfeeding Self-Efficacy
timeFrame: until discharge from the hospital an average 24 week
measure: rate of physiological jaundice
timeFrame: until discharge from the hospital an average 2 week
measure: rate of exclusive breastfeeding
timeFrame: until discharge from the hospital an average 24 week
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: RN, PhD, Assoc. Prof.
name: Gülçin Özalp Gerçeker
role: PRINCIPAL_INVESTIGATOR
References: