BreastfeedingNCT06009120
Psychosexual Development Theory-Based Breastfeeding Education
A study testing Education in people with Breastfeeding and Psychosocial Development, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Breastfeeding education based on the theory of psychosexual development is important as it addresses the social and psychological significance of childhood and the impact of early childhood experiences on later social anxieties and psychosexual well-being. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Psychosocial Development, Nursing Caries
- What is being tested?
- Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 31 Jul 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- being primitive,
- being 18 years or older,
- having a healthy birth,
- using a mobile phone,
- being within 72-96 hours after birth,
- participating in the research voluntarily.
Who cannot join
- having cognitive problems,
- delivering a premature newborn, having a baby in the neonatal intensive care unit,
- having a health problem that would prevent her from breastfeeding the baby,
- using any sedatives, anticonvulsants, or analgesics, don't the ability to speak Turkish,
- giving formula to their baby for any reason within the first three days,
- having a life-threatening illness or condition,
- not being willing to participate in the study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Psychosexual Development Theory-Based Breastfeeding Education on Infant Feeding Attitudes and Knowledge of Primiparous Mothers: A Randomized Controlled Study
Breastfeeding education based on the theory of psychosexual development is important as it addresses the social and psychological significance of childhood and the impact of early childhood experiences on later social anxieties and psychosexual well-being. However, no theory-based breastfeeding education given to the mothers was found in the literature. Therefore, the study aimed to investigate the effect of breastfeeding education on infant feeding attitudes and knowledge of primiparous mothers, in line with the theory of psychosocial development.
Read the detailed description
Breastfeeding is known to play a health-enhancing and disease-preventive role for both the mother and the baby. While it is recognized to reduce postpartum blood loss in mothers and provide protection against conditions like depression, Type 2 diabetes, hypertension, and breast \& ovarian cancer; for infants, it is noted that breastfeeding offers protection against many infectious diseases due to the antibodies it, reduces sudden infant deaths and decreases mortality under the age of five [6]. However, despite these benefits, breastfeeding rates have not yet reached desired levels in many countries today.
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that during the first six months, infants should be exclusively breastfed, avoiding the use of water, other liquids, supplementary foods/formula, and solid foods.In our country, according to the Turkey Demographic and Health Survey 2018 data, the rate of exclusive breastfeeding during the first six months is 41%. Among these mothers, it has been determined that 41.7% of them provide their babies with additional liquids/foods other than breast milk within the first three days after birth. Contrary to recommendations, the use of additional liquids/foods in the early days increases the risk of discontinuing breastfeeding before six months by threefold.
Regardless of medical reasons, the main reasons for the consumption of supplementary foods/formula in the early days include the baby's frequent hunger cues and the mother's concern that her milk might not be sufficient. Additionally, the physiological weight loss that newborns experience in the first few days after birth further supports and amplifies mothers' concerns of "not having enough milk." After the 3rd to 5th day following birth, as milk production advances in the mother's body, the subsequent process involves milk becoming fattier and the baby beginning to gain weight. Therefore, it is crucial for mothers to be properly informed about this process, including the baby's behaviors and the content of the milk.
In addition to these physiological changes, Freud has developed a theory on psychosexual development. At the core of the theory lies a pleasurable pursuit for bodily sensations and control. The period from birth to one year of age is referred to as the "Oral Stage" in that theory. During this period, it is emphasized that the newborn starts to explore the world orally and derives satisfaction/pleasure from sucking behavior. Examples of this are finger sucking, pacifier use, and the behavior of putting any object they hold into their mouth, commonly observed in babies. These are typical processes of a healthy newborn and a developing baby within the context of psychosexual development over time. Hence, infants can exhibit hunger cues not only to satisfy their hunger but also for the purpose of experiencing pleasure. However, no study in the literature has directly correlated this information with newborn-sucking behavior. Current research underscores the need for effective interventions with proper timing and highlights that primiparous mothers tend to have greater concerns about insufficient milk than multiparous mothers. Proper guidance and information about physiological processes are crucial for acquiring breastfeeding behavior. In this study, in line with Freud's psychosexual development theory, the impact of breastfeeding education provided after childbirth on primiparous mothers' feeding attitudes and behaviors has been investigated.
- Conditions
- Breastfeeding, Psychosocial Development, Nursing Caries
- Being tested
- Education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
The education program emphasized the characteristics of the oral stage, positive traits that can be acquired when the baby's needs are met during this stage, negative traits that may develop in the baby when their needs are not met, and the relationship between the oral stage and breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention (education) group:
In addition to the standard discharge education, mothers in this group received breastfeeding education. Receives: Other: Education |
| Control | No intervention | Control group: In this group, first of all, mothers were informed about the study within the first day after birth, and informed consent forms were signed by those who voluntarily agreed to participate. In addition, "Personal Information Form", "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Information Scale" were applied to these mothers on the first day. Then, as the routine care of the institution, the standard discharge education program on the third day was applied by the institution nurse. After this education, "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Knowledge Form" were re-administered to mothers as a post-test. No additional intervention was applied other than standard care education. During the 5 days following discharge, mothers were interviewed by phone and "Breastfeeding Form'' applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOWA Infant Feeding Attitude Scale
The scale was developed by De La Mora et al. in 1999 to assess the attitudes of women towards breastfeeding and to predict the choice of infant feeding method as well as the duration of breastfeeding. The total attitude score ranges from 17 (indicating a positive attitude towards bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding).
Measured: 1 WEEK
Breastfeeding Form
This form was created by the researchers to evaluate the mothers' experiences of breastfeeding and using formula for one week after birth. The form includes four questions about breastfeeding frequency \& duration and formula use \& frequency from day to day.
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 posted24 Aug 2023
- Study start1 Dec 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who met the sample selection criteria were randomly divided into two groups, an intervention (education) group and a CG, using a computer-based program (www.random.org). The assignment to the intervention and CG was performed by an independent statistician. Thus, by implementing randomized allocation and concealing the randomization, selection bias was controlled. In the study, participant blinding was carried out, but researcher blinding was not possible due to the researcher's awareness of the intervention being administered. In a 1:1 ratio, the women were separated into intervention and CGs (Figure 1).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
- Investigators
- Eyşan Hanzade UMAÇ, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009120
- Sponsor's protocol ID
- Eyşan Hanzade Savaş
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Savas EH, Semerci R, Eroglu K, Can N, Ozturk A. Impact of psychosexual development theory-based breastfeeding education on infant feeding attitudes and knowledge of primiparous mothers: A randomized controlled study. J Pediatr Nurs. 2024 Jul-Aug;77:e503-e510. doi: 10.1016/j.pedn.2024.05.016. Epub 2024 May 18.
PubMed 38762425
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Psychosexual Development Theory-Based Breastfeeding Education on Infant Feeding Attitudes and Knowledge of Primiparous Mothers: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06009120
- Acronym / sponsor ID
- Eyşan Hanzade Savaş
- Conditions
- Breastfeeding, Psychosocial Development, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Aug 2023 (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.
Breastfeeding education based on the theory of psychosexual development is important as it addresses the social and psychological significance of childhood and the impact of early childhood experiences on later social anxieties and psychosexual well-being. However, no theory-based breastfeeding education given to the mothers was found in the literature. Therefore, the study aimed to investigate the effect of breastfeeding education on infant feeding attitudes and knowledge of primiparous mothers, in line with the theory of psychosocial development.
Detailed description
Breastfeeding is known to play a health-enhancing and disease-preventive role for both the mother and the baby. While it is recognized to reduce postpartum blood loss in mothers and provide protection against conditions like depression, Type 2 diabetes, hypertension, and breast \& ovarian cancer; for infants, it is noted that breastfeeding offers protection against many infectious diseases due to the antibodies it, reduces sudden infant deaths and decreases mortality under the age of five [6]. However, despite these benefits, breastfeeding rates have not yet reached desired levels in many countries today.
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that during the first six months, infants should be exclusively breastfed, avoiding the use of water, other liquids, supplementary foods/formula, and solid foods.In our country, according to the Turkey Demographic and Health Survey 2018 data, the rate of exclusive breastfeeding during the first six months is 41%. Among these mothers, it has been determined that 41.7% of them provide their babies with additional liquids/foods other than breast milk within the first three days after birth. Contrary to recommendations, the use of additional liquids/foods in the early days increases the risk of discontinuing breastfeeding before six months by threefold.
Regardless of medical reasons, the main reasons for the consumption of supplementary foods/formula in the early days include the baby's frequent hunger cues and the mother's concern that her milk might not be sufficient. Additionally, the physiological weight loss that newborns experience in the first few days after birth further supports and amplifies mothers' concerns of "not having enough milk." After the 3rd to 5th day following birth, as milk production advances in the mother's body, the subsequent process involves milk becoming fattier and the baby beginning to gain weight. Therefore, it is crucial for mothers to be properly informed about this process, including the baby's behaviors and the content of the milk.
In addition to these physiological changes, Freud has developed a theory on psychosexual development. At the core of the theory lies a pleasurable pursuit for bodily sensations and control. The period from birth to one year of age is referred to as the "Oral Stage" in that theory. During this period, it is emphasized that the newborn starts to explore the world orally and derives satisfaction/pleasure from sucking behavior. Examples of this are finger sucking, pacifier use, and the behavior of putting any object they hold into their mouth, commonly observed in babies. These are typical processes of a healthy newborn and a developing baby within the context of psychosexual development over time. Hence, infants can exhibit hunger cues not only to satisfy their hunger but also for the purpose of experiencing pleasure. However, no study in the literature has directly correlated this information with newborn-sucking behavior. Current research underscores the need for effective interventions with proper timing and highlights that primiparous mothers tend to have greater concerns about insufficient milk than multiparous mothers. Proper guidance and information about physiological processes are crucial for acquiring breastfeeding behavior. In this study, in line with Freud's psychosexual development theory, the impact of breastfeeding education provided after childbirth on primiparous mothers' feeding attitudes and behaviors has been investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who met the sample selection criteria were randomly divided into two groups, an intervention (education) group and a CG, using a computer-based program (www.random.org). The assignment to the intervention and CG was performed by an independent statistician. Thus, by implementing randomized allocation and concealing the randomization, selection bias was controlled. In the study, participant blinding was carried out, but researcher blinding was not possible due to the researcher's awareness of the intervention being administered. In a 1:1 ratio, the women were separated into intervention and CGs (Figure 1).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: EducationIntervention (education) group: In addition to the standard discharge education, mothers in this group received breastfeeding education. |
| Control | No intervention | –Control group: In this group, first of all, mothers were informed about the study within the first day after birth, and informed consent forms were signed by those who voluntarily agreed to participate. In addition, "Personal Information Form", "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Information Scale" were applied to these mothers on the first day. Then, as the routine care of the institution, the standard discharge education program on the third day was applied by the institution nurse. After this education, "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Knowledge Form" were re-administered to mothers as a post-test. No additional intervention was applied other than standard care education. During the 5 days following discharge, mothers were interviewed by phone and "Breastfeeding Form'' applied. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- being primitive,
- being 18 years or older,
- having a healthy birth,
- using a mobile phone,
- being within 72-96 hours after birth,
Key exclusion criteria (7 listed)
- having cognitive problems,
- delivering a premature newborn, having a baby in the neonatal intensive care unit,
- having a health problem that would prevent her from breastfeeding the baby,
- using any sedatives, anticonvulsants, or analgesics, don't the ability to speak Turkish,
- giving formula to their baby for any reason within the first three days,
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 |
|---|---|---|
| EducationThe education program emphasized the characteristics of the oral stage, positive traits that can be acquired when the baby's needs are met during this stage, negative traits that may develop in the baby when their needs are not met, and the relationship between the oral stage and breastfeeding. | Other | Intervention |
Primary outcome
IOWA Infant Feeding Attitude Scale
Time frame: 1 WEEK
The scale was developed by De La Mora et al. in 1999 to assess the attitudes of women towards breastfeeding and to predict the choice of infant feeding method as well as the duration of breastfeeding. The total attitude score ranges from 17 (indicating a positive attitude towards bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding).
Breastfeeding Form
Time frame: 1 WEEK
This form was created by the researchers to evaluate the mothers' experiences of breastfeeding and using formula for one week after birth. The form includes four questions about breastfeeding frequency \& duration and formula use \& frequency from day to day.
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 5 Sep 2023.
- Derived from this study: PubMed 38762425Savas EH, Semerci R, Eroglu K, Can N, Ozturk A. Impact of psychosexual development theory-based breastfeeding education on infant feeding attitudes and knowledge of primiparous mothers: A randomized controlled study. J Pediatr Nurs. 2024 Jul-Aug;77:e503-e510. doi: 10.1016/j.pedn.2024.05.016. Epub 2024 May 18.
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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.
Eyşan Hanzade UMAÇ principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Breastfeeding and Psychosocial Development, run by Koç University 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 6 inclusion and 7 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 5 Sep 2023. 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?
IOWA Infant Feeding Attitude Scale (time frame: 1 WEEK). The study lists 2 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 NCT06009120, which also lists 1 linked publication.
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 5 Sep 2023.