Clinical trial NCT06585111: Effect of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration
Official title: The Effect Of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration In Twin Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Keywords: Breas Feeding
Twins
Motivational Interviewing
Self Efficacy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were divided into two groups: intervention and control groups. Interventions and follow-ups were carried out in six determined time periods.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this prospective, randomized controlled experimental clinical trial was to examine the effect of individual counseling interventions based on the Health Action Process Approach Model on breastfeeding duration in twin pregnancies. Women in the intervention group received breastfeeding education using motivational interviewing techniques, while women in the control group received routine clinical education and no intervention. Hypotheses of the study:

H1: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding self-efficacy than the control group.

H2: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding intentions than the control group.

H3: Postnatal breastfeeding self-efficacy of women who received individual intervention based on SESY model is higher than the control group.

H4: Breastfeeding motivation of women who received individual intervention based on the SESY model is higher than the control group.

H5: Women who received individual intervention based on the SESY model had higher rates of exclusive breastfeeding than the control group.

The women in the intervention group were given breastfeeding education with motivational interviewing techniques at 28-38 weeks of pregnancy in the prenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. The women in the control group did not receive any training by the researcher.

Detailed description: Evaluate the effect of individual counseling interventions based on the Health Action Process Approach Model (HAPA) on breastfeeding duration in twin pregnancies.

A total of 34 women in the intervention group and 34 women in the control group were followed up six times at 28-38 weeks in the antenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. Personal Information Form, HAPA Model Antenatal Period Motivational Interview Questionnaire, HAPA Model Postpartum Period Motivational Interview Questionnaire, Prenatal Breastfeeding Self-Efficacy Scale, Breastfeeding Intention Scale in Pregnant Women Expecting Twins, Breastfeeding Follow-up Form, Breastfeeding Motivation Scale Turkish version, Postnatal Breastfeeding Self-Efficacy Scale were applied to the intervention group. In the control group, Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, Breastfeeding Intention Scale in Pregnant Women Expecting Twins, Breastfeeding Follow-up Form, Breastfeeding Motivation Scale Turkish version, Postnatal Breastfeeding Self-Efficacy Scale were applied and they were followed up with routine clinical trainings.

Eligibility criteria: Inclusion Criteria:

* Who agreed to participate in the study,
* 18 years of age or older,
* Can speak and understand Turkish,
* Can read and write,
* Mothers whose breasts are suitable for breastfeeding
* Weeks between (28+0)-(37+6) of pregnancy

Exclusion Criteria:

* The baby has an anomaly in the mouth area
* The woman has language and communication problems
* The breasts are not suitable for breastfeeding (history of mastectomy surgery on both breasts)
* The mother or the baby is taking medication that prevents breastfeeding
* The woman has a previously diagnosed psychiatric disorder
* The mother does not plan to breastfeed her babies

Primary outcomes:
measure: Breastfeeding duration of twin babies until the sixth month postpartum after counseling
timeFrame: Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months
Secondary outcomes:
measure: Duration of exclusive breastfeeding of twin babies after consultation until the sixth month after birth
timeFrame: postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months
measure: Breastfeeding Intention Level
timeFrame: In the prenatal period between 28-38 weeks of gestation
measure: Prenatal Breastfeeding Self Efficacy Level
timeFrame: In the Prenatal period between 28-38 weeks of gestation
measure: Postnatal Breastfeeding Self Efficacy Scale Level
timeFrame: Postpartum 1-3 days, postpartum 4-6 weeks, and postpartum 4th month.
measure: Breastfeeding Motivation Level in Mothers of Twin Babies
timeFrame: 1-3 days postpartum, 4-6 weeks postpartum, and 4th month postpartum
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
affiliation: Ege University
name: Oya Kavlak, Prof. Dr.
role: STUDY_DIRECTOR
References: