Breastfeeding EducationNCT05246748
Human Caring Theory-based Breastfeeding Education
A study testing Human Caring Theory based Education and Standard Education in people with Breastfeeding Education, run by Gamze Durmazoğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Education
- What is being tested?
- Human Caring Theory based Education and Standard Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women with 28-34 weeks of pregnancy able to speak and understand Turkish without any communication barrier were
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breastfeeding Education
- Being tested
- Human Caring Theory based Education, Standard Education
- Keywords
- Theory of Human Caring, Breastfeeding, Nursing, Self-efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Caring Theory based EducationOther
The intervention group was given a breastfeeding education program based on the HCT for six face to face sessionconducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period.
Standard EducationOther
The control group received solely standard education program for one sessions in prenatal period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group was given a breastfeeding education program based on the HCT for six face to face sessionconducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period. Receives: Other: Human Caring Theory based Education |
| Control group | Active comparator | The control group received solely standard education program for one sessions in prenatal period. Receives: Other: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREASTFEEDİNG SELF-EFFİCACY
BREASTFEEDİNG SELF-EFFİCACY SCORE
Measured: Change from breastfeeding self-efficacy at 6 months
BREASTFEEDİNG DURATION
HOW LONG BREASTFEEDİNG CONTİNUES
Measured: Change from breastfeeding duration at 6 months
THE BABY FEEDİNG DEFİNİTİON FORM
EXPLAINS THE TYPE OF BREASTFEEDING.SUCH AS EXCLUSİVE BREASTFEEDİNG OR PARİTAL BREASTFEEDİNG ETC.
Measured: Change from the babies breastfeeding definition at 6 months
WATSON CARİTAS PATİENT SCORE
DETERMINES WOMEN'S SATISFACTION LEVELS WITH THE EDUCATION THEY RECEIVE. IN THIS STUDY, MOTHERS WITH HIGH WATSON CARITAS PATIENT SCORES ALSO HAVE HIGH LEVELS OF SATISFACTION WITH THE EDUCATION PROCESS.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze Durmazoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gamze Durmazoğlu, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246748
- Sponsor's protocol ID
- GmZ!2805
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Underlie results in a publication
Publications
Almohanna AA, Win KT, Meedya S. Effectiveness of Internet-Based Electronic Technology Interventions on Breastfeeding Outcomes: Systematic Review. J Med Internet Res. 2020 May 29;22(5):e17361. doi: 10.2196/17361.
PubMed 32469315Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
PubMed 18541350Arslan-Ozkan I, Okumus H, Buldukoglu K. A randomized controlled trial of the effects of nursing care based on Watson's Theory of Human Caring on distress, self-efficacy and adjustment in infertile women. J Adv Nurs. 2014 Aug;70(8):1801-12. doi: 10.1111/jan.12338. Epub 2013 Dec 22.
PubMed 24372443Bai YK, Lee S, Overgaard K. Critical Review of Theory Use in Breastfeeding Interventions. J Hum Lact. 2019 Aug;35(3):478-500. doi: 10.1177/0890334419850822. Epub 2019 May 17.
PubMed 31100027Bensley RJ, Hovis A, Horton KD, Loyo JJ, Bensley KM, Phillips D, Desmangles C. Accessibility and preferred use of online Web applications among WIC participants with Internet access. J Nutr Educ Behav. 2014 May-Jun;46(3 Suppl):S87-92. doi: 10.1016/j.jneb.2014.02.007.
PubMed 24810002Boateng GO, Martin SL, Tuthill EL, Collins SM, Dennis CL, Natamba BK, Young SL. Adaptation and psychometric evaluation of the breastfeeding self-efficacy scale to assess exclusive breastfeeding. BMC Pregnancy Childbirth. 2019 Feb 18;19(1):73. doi: 10.1186/s12884-019-2217-7.
PubMed 30777020Brewer BB, Watson J. Evaluation of Authentic Human Caring Professional Practices. J Nurs Adm. 2015 Dec;45(12):622-7. doi: 10.1097/NNA.0000000000000275.
PubMed 26502069Brockway M, Benzies K, Hayden KA. Interventions to Improve Breastfeeding Self-Efficacy and Resultant Breastfeeding Rates: A Systematic Review and Meta-Analysis. J Hum Lact. 2017 Aug;33(3):486-499. doi: 10.1177/0890334417707957. Epub 2017 Jun 23.
PubMed 28644764Cangöl, E., Hotun Şahin, N. (2017). A Model of Breastfeeding Support: Motivational Interviews Based On Pender's Health Promotion Model. HJournal of Education and Research in Nursing, 14 (1), 98-103. doi: 10.5222/HEAD.2017.098
Chan MY, Ip WY, Choi KC. The effect of a self-efficacy-based educational programme on maternal breast feeding self-efficacy, breast feeding duration and exclusive breast feeding rates: A longitudinal study. Midwifery. 2016 May;36:92-8. doi: 10.1016/j.midw.2016.03.003. Epub 2016 Mar 8.
PubMed 27106949Chauhan SP, Blackwell SC, Saade GR; Society for Maternal-Fetal Medicine Health Policy Committee. A suggested approach for implementing CONSORT guidelines specific to obstetric research. Obstet Gynecol. 2013 Nov;122(5):952-956. doi: 10.1097/AOG.0b013e3182a9c9af.
PubMed 24104788Chipojola R, Chiu HY, Huda MH, Lin YM, Kuo SY. Effectiveness of theory-based educational interventions on breastfeeding self-efficacy and exclusive breastfeeding: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Sep;109:103675. doi: 10.1016/j.ijnurstu.2020.103675. Epub 2020 Jun 6.
PubMed 32585447Dennis CL. Identifying predictors of breastfeeding self-efficacy in the immediate postpartum period. Res Nurs Health. 2006 Aug;29(4):256-68. doi: 10.1002/nur.20140.
PubMed 16847899Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
PubMed 14649593Dennis CL. Theoretical underpinnings of breastfeeding confidence: a self-efficacy framework. J Hum Lact. 1999 Sep;15(3):195-201. doi: 10.1177/089033449901500303. No abstract available.
PubMed 10578797
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05246748
- Acronym / sponsor ID
- GmZ!2805
- Conditions
- Breastfeeding Education
- Keywords
- Theory of Human Caring, Breastfeeding, Nursing, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gamze DurmazoğluUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Human Caring Theory based EducationThe intervention group was given a breastfeeding education program based on the HCT for six face to face sessionconducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period. |
| Control group | Active comparator | Other: Standard EducationThe control group received solely standard education program for one sessions in prenatal period. |
Who may qualify
- Ages
- 19 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primiparous women with 28-34 weeks of pregnancy able to speak and understand Turkish without any communication barrier were
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Caring Theory based EducationThe intervention group was given a breastfeeding education program based on the HCT for six face to face sessionconducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period. | Other | Intervention group |
| Standard EducationThe control group received solely standard education program for one sessions in prenatal period. | Other | Control group |
Primary outcome
BREASTFEEDİNG SELF-EFFİCACY
Time frame: Change from breastfeeding self-efficacy at 6 months
BREASTFEEDİNG SELF-EFFİCACY SCORE
BREASTFEEDİNG DURATION
Time frame: Change from breastfeeding duration at 6 months
HOW LONG BREASTFEEDİNG CONTİNUES
THE BABY FEEDİNG DEFİNİTİON FORM
Time frame: Change from the babies breastfeeding definition at 6 months
EXPLAINS THE TYPE OF BREASTFEEDING.SUCH AS EXCLUSİVE BREASTFEEDİNG OR PARİTAL BREASTFEEDİNG ETC.
WATSON CARİTAS PATİENT SCORE
Time frame: 1 week
DETERMINES WOMEN'S SATISFACTION LEVELS WITH THE EDUCATION THEY RECEIVE. IN THIS STUDY, MOTHERS WITH HIGH WATSON CARITAS PATIENT SCORES ALSO HAVE HIGH LEVELS OF SATISFACTION WITH THE EDUCATION PROCESS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 32469315Almohanna AA, Win KT, Meedya S. Effectiveness of Internet-Based Electronic Technology Interventions on Breastfeeding Outcomes: Systematic Review. J Med Internet Res. 2020 May 29;22(5):e17361. doi: 10.2196/17361.
- Background: PubMed 18541350Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
- Background: PubMed 24372443Arslan-Ozkan I, Okumus H, Buldukoglu K. A randomized controlled trial of the effects of nursing care based on Watson's Theory of Human Caring on distress, self-efficacy and adjustment in infertile women. J Adv Nurs. 2014 Aug;70(8):1801-12. doi: 10.1111/jan.12338. Epub 2013 Dec 22.
- Background: PubMed 31100027Bai YK, Lee S, Overgaard K. Critical Review of Theory Use in Breastfeeding Interventions. J Hum Lact. 2019 Aug;35(3):478-500. doi: 10.1177/0890334419850822. Epub 2019 May 17.
- Background: PubMed 24810002Bensley RJ, Hovis A, Horton KD, Loyo JJ, Bensley KM, Phillips D, Desmangles C. Accessibility and preferred use of online Web applications among WIC participants with Internet access. J Nutr Educ Behav. 2014 May-Jun;46(3 Suppl):S87-92. doi: 10.1016/j.jneb.2014.02.007.
- Background: PubMed 30777020Boateng GO, Martin SL, Tuthill EL, Collins SM, Dennis CL, Natamba BK, Young SL. Adaptation and psychometric evaluation of the breastfeeding self-efficacy scale to assess exclusive breastfeeding. BMC Pregnancy Childbirth. 2019 Feb 18;19(1):73. doi: 10.1186/s12884-019-2217-7.
- Background: PubMed 26502069Brewer BB, Watson J. Evaluation of Authentic Human Caring Professional Practices. J Nurs Adm. 2015 Dec;45(12):622-7. doi: 10.1097/NNA.0000000000000275.
- Background: PubMed 28644764Brockway M, Benzies K, Hayden KA. Interventions to Improve Breastfeeding Self-Efficacy and Resultant Breastfeeding Rates: A Systematic Review and Meta-Analysis. J Hum Lact. 2017 Aug;33(3):486-499. doi: 10.1177/0890334417707957. Epub 2017 Jun 23.
- BackgroundCangöl, E., Hotun Şahin, N. (2017). A Model of Breastfeeding Support: Motivational Interviews Based On Pender's Health Promotion Model. HJournal of Education and Research in Nursing, 14 (1), 98-103. doi: 10.5222/HEAD.2017.098
- Background: PubMed 27106949Chan MY, Ip WY, Choi KC. The effect of a self-efficacy-based educational programme on maternal breast feeding self-efficacy, breast feeding duration and exclusive breast feeding rates: A longitudinal study. Midwifery. 2016 May;36:92-8. doi: 10.1016/j.midw.2016.03.003. Epub 2016 Mar 8.
- Background: PubMed 24104788Chauhan SP, Blackwell SC, Saade GR; Society for Maternal-Fetal Medicine Health Policy Committee. A suggested approach for implementing CONSORT guidelines specific to obstetric research. Obstet Gynecol. 2013 Nov;122(5):952-956. doi: 10.1097/AOG.0b013e3182a9c9af.
- Background: PubMed 32585447Chipojola R, Chiu HY, Huda MH, Lin YM, Kuo SY. Effectiveness of theory-based educational interventions on breastfeeding self-efficacy and exclusive breastfeeding: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Sep;109:103675. doi: 10.1016/j.ijnurstu.2020.103675. Epub 2020 Jun 6.
- Global Nutrition Targets 2025 Breastfeeding Policy BriefLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Caring Theory based Education and Standard Education in people with Breastfeeding Education, run by Gamze Durmazoğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BREASTFEEDİNG SELF-EFFİCACY (time frame: Change from breastfeeding self-efficacy at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246748, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.