Clinical trial NCT05246748: Human Caring Theory-based Breastfeeding Education
Official title: Does Watson's Human Caring Theory-based Breastfeeding Educational and Support Programme Affects Mothers Breastfeeding Self-efficacy, Duration, Definitions and Satisfaction?: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Education
Keywords: Theory of Human Caring
Breastfeeding
Nursing
Self-efficacy
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is a randomized controlled prospective study. The purpose of the study is to examine the effect of breastfeeding education and support program based on Human Caring Theory (HCT) on mothers' breastfeeding self-efficacy, duration and definitions, and their satisfaction with this process. As a result, Human Caring Theory based breastfeeding education program improved breastfeeding self-efficacy, duration and exclusive breastfeeding.

Detailed description: Although breastfeeding have many benefits, breastfeeding rates are still not at the desired level. One of the most important factors in increasing breastfeeding rates is breastfeeding education. Therefore, the purpose of the study is to examine the effect of breastfeeding education and support program based on Human Caring Theory (HCT) on mothers' breastfeeding self-efficacy, duration and definitions, and their satisfaction with this process.

It is a randomized controlled prospective study conducted between January 2019- March 2020 in 100 Turkish women (intervention:50; control: 50). A simple randomization method was performed using the siterandomizer.org to ensure samples' equality in two groups. The participants were randomly assigned to the groupwith Human Caring Theory based education and support (intervention) or a standard education program (control) group. The study method was explained, and informed consent was obtained from all participants. The researcher applied the education and support, and hence, blinding could not be done.

An intervention program was prepared by researchers who received many trainings on the practical use of Watson Human Caring theory. Watson Human Caring Theory based education and support program was conducted in groups of 6-8 pregnant woman in prenatal period and continues individualty web- based and by phone support in postnatal period. Two experts who have PhD degree in women's health nursing assessed the validity of the breastfeeding education program based on the HCT. The intervention group was given a breastfeeding education program based on the HCT for six face to face session conducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period. The control group received solely standard education program for one sessions in prenatal period. Especially in postnatal period traditional face-to-face breastfeeding education and support may not be easy for women and their families. The "Breastfeeding Self-Efficacy Scale", "Baby's Feeding Definition Form" and "Watson Caritas Patient Score"instruments were used for data collection.

Women's Descriptive Characteristics Question Form, The Baby's FeedingDefinition Form, Breastfeeding Self- Efficacy Scale-Short Form and Watson Caritas Patient Score were the instruments used for data collection.

Women's Descriptive Characteristics Question Formincluded ten questions related to age, education level, previous breastfeeding educationand gestational age.

In order to asses baby's feeding, The Baby Feeding Definition Form was used. This form was prepared by researchers in line with literatüre. The questions such as the baby's sucking status, the status of receiving liquid or nutrients other than breast milk, and the baby's appearance of peace after sucking were based on Labbok and Krasovec (1990) and WHO classificationts relted to baby breast milk intake level. At the same time the state of peace of the baby was evaluated according to the expressions of the mothers. Consequently three breastfeeding experts evaluated the form and found it suitable for the assessment of infants' feeding level. The responses obtained from the evaluation form were classified according to the diagnostic criteria for breastfeeding by Labbok and Krosovec (1990).

The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) comprised 14 items developed by Dennis in 2003. The BSES-SFis a 5-point Likert-type scale, with 1meaning "not at all confident" and 5 meaning "very confi-dent," yielding a minimum possible score of 14 points and a maximum score of 70 points. Regarding this scale a high score indicates high breast-feedingself-efficacy. The scale had a Cronbach's alpha value of 0.94. Turkish validity and reliability of the scale were done by Tokat, Okumuş and Dennis (2010). In the same study, Cronbach's alpha coefficient for internal consistency was 0.87 antenatally and 0.86 postnatally. Prenatal items was created by using the future tense expression in the antenatal form of the breastfeeding self-efficacy scale.

The Watson Caritas Patient Score (WCPS) was used to assess satisfaction of the education program. WCPS was developed based on caritas factors and caritas processes by Dr. Jean Watson et al. (2010). WCPS is a reliable and valid instrument used in hospitals and systems to assess perspectives of caring practices of hospital staff, of colleagues and peers.The WCPS items are each scored on a 7-point scale, ranging from "not at all" (1) to "very much" (7). The reliability was confirmed with a Cronbach's α of .90. (Brewer \& Watson, 2015). The internal consistency of the WCPS assessed using Cronbach's alpha was .90 in Turkey (Durmazoglu, 2020).The highest score that can be obtained from WCPS is 35, and the lowest score is five. In this form there is also comments and suggestions section. In this section people can write their comments for more effective process.

The data were analyzed using the Statistical Package for Social Sciences (SPSS 22.0) for Windows. The normal distribution of the data was evaluated using the Kolmogorov-Smirnov test. The descriptive statistics of the study were evaluated with frequency, mean, standard deviation, number and percentage. Pearson's chi-square test was used to evaluate the homogeneity of the data according to the groups. The t-test was used for comparisons between variables in two categories. Multiple and one-way analysis of variance was used for repeated measurements. The reliability of the scales was tested with Cronbach's alpha. The significance threshold was set at 0.05.

Eligibility criteria: Inclusion Criteria:

* Primiparous women with 28-34 weeks of pregnancy able to speak and understand Turkish without any communication barrier were

Exclusion Criteria:

* Having some (a) maternal problems (mastectomy, mastitis and drug use, psychiatric diseases, etc.),or (b) infant problems(cleft palate, chromosomal anomalies, neurological diseases that will adversely affect breastfeeding, etc.) were determined as exclusion criteria.

Primary outcomes:
measure: BREASTFEEDİNG SELF-EFFİCACY
timeFrame: Change from breastfeeding self-efficacy at 6 months
measure: BREASTFEEDİNG DURATION
timeFrame: Change from breastfeeding duration at 6 months
measure: THE BABY FEEDİNG DEFİNİTİON FORM
timeFrame: Change from the babies breastfeeding definition at 6 months
measure: WATSON CARİTAS PATİENT SCORE
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gamze DURMAZOĞLU
Study officials:
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