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Completed

NCT Number: NCT06585111

Effect of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Other

In the first motivational interview, the "HAPA Model Prenatal Motivation Interview Questionnaire", the first part of the "Personal Information Form", the "Prenatal Breastfeeding Self-Efficacy Scale", and the "Breastfeeding Intention Scale for Pregnant Women Expecting Twins" were applied. A brochure on breastfeeding twin babies prepared by the researcher was distributed to women. In the second interview, the "HAPA Model Postpartum Motivation Interview Scale", the second part of which was the "Personal Information Form", "Breastfeeding Follow-up Form", "Breastfeeding Motivation Scale" and "Postpartum Breastfeeding Self-Efficacy Scale" were applied. In the third meeting, the "Breastfeeding Follow-up Form" was applied. "Breastfeeding Motivation Scale", "Postpartum Breastfeeding Self-Efficacy Scale" and "Breastfeeding Follow-up Form" were applied in the fourth and fifth interviews, and "Breastfeeding Follow-up Form" was applied in the sixth interview.

Primary outcomes

  1. Breastfeeding duration of twin babies until the sixth month postpartum after counseling

    Time frame: Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months

    The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk.

Secondary outcomes

  1. Duration of exclusive breastfeeding of twin babies after consultation until the sixth month after birth

    Time frame: postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months

    The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk.

  2. Breastfeeding Intention Level

    Time frame: In the prenatal period between 28-38 weeks of gestation

    The breastfeeding intention level of mothers of twin babies was measured with the breastfeeding intention scale in the prenatal period.The scale is a 5-point Likert scale. Items are scored from strongly disagree 1 to strongly agree 5. A minimum of 7 and a maximum of 35 points can be obtained from the scale. The higher the total score obtained from the scale, the higher the breastfeeding intention of pregnant women expecting twins. The scale can be used in both primiparous and multiparous pregnant women from the 20th gestational week until delivery. The scale can be easily completed by literate individuals.

  3. Prenatal Breastfeeding Self Efficacy Level

    Time frame: In the Prenatal period between 28-38 weeks of gestation

    The prenatal breastfeeding self-efficacy level of the mothers of twin babies was measured with the prenatal breastfeeding self-efficacy scale after breastfeeding training with motivational interviewing techniques. The scale consists of a total of 19 items and four subgroups. Each item of the scale is classified as "1=Not at all sure", "2=Slightly sure", 3=Quite sure", 4=Very sure", 5= Completely sure". It is graded on a 5-point Likert scale. The lowest score that can be obtained from the total scale is 19 and the highest score is 95. It is evaluated over the total score. The higher the score, the higher the perception of breastfeeding self-efficacy.

  4. Postnatal Breastfeeding Self Efficacy Scale Level

    Time frame: Postpartum 1-3 days, postpartum 4-6 weeks, and postpartum 4th month.

    The postpartum breastfeeding self-efficacy levels of the mothers of twin babies were measured with the postnatal breastfeeding self-efficacy scale after breastfeeding training with motivational interviewing techniques. The Breastfeeding Self-Efficacy Scale developed by Dennis in 1999 consists of 33 items. Dennis developed the short form of the Breastfeeding Self-Efficacy Scale in 2003 by reducing it to 14 items. The Short Form Breastfeeding Self-Efficacy Scale is a 5-point Likert-type scale with 1= "I am never sure" and 5 = "I am always sure". The higher the score, the higher the breastfeeding self-efficacy.

  5. Breastfeeding Motivation Level in Mothers of Twin Babies

    Time frame: 1-3 days postpartum, 4-6 weeks postpartum, and 4th month postpartum

    The level of breastfeeding motivation in mothers of twin babies was measured by motivational interviewing techniques and breastfeeding motivation scale after breastfeeding education. The scale consists of 24 items. The scale was adapted into Turkish by Mızrak and Özerdoğan in 2017. The scale consists of 6 sub-dimensions. These are; integrated regulation first sub-dimension 13,14,16,19,15,21,18,24,22,23, intrinsic motivation and identified regulation second sub-dimension 11,8,16,3,14.6,8,11,13, internalized regulation-social approval third sub-dimension 4,5, internalized regulation-social pressure fourth sub-dimension 7,9, external regulation-infant health fifth sub-dimension 2,12. and external regulation-additional benefits sixth sub-dimension 20,1,17,10. Scale items are graded from 1=strongly disagree to 4=strongly agree.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect Of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration In Twin Pregnancies

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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