Primiparous WomenNCT05866588
The Effect of Nursing Care on Maternal Role Performance and Parental Self-Efficacy of Primiparous Women
A study testing Physical, psychological and spiritual nursing care (Nursing Therapeutics) in people with Primiparous Women, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Being a mother is a major and developmental life event involving the transition from an existing and known reality to a new unknown reality, in which the woman gains a new role. In the literature, factors such as age, social support, physical and psychosocial well-being, unrealistic positive or negative expectations… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparous Women
- What is being tested?
- Physical, psychological and spiritual nursing care (Nursing Therapeutics)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Mar 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To agree to participate in the research voluntarily.
- To be able to read and write Turkish.
- Not to have a diagnosed psychiatric disease or communication problem.
- Having a mobile phone capable of receiving and playing video messages.
- Being healthy and having a single pregnancy.
- To be between 28-32 weeks of pregnancy.
- Living with a spouse or partner.
Who cannot join
- Not accepting to participate in the research voluntarily.
- Not being literate in Turkish.
- Having a diagnosed psychiatric illness or communication problem.
- Lack of mobile phone capable of receiving and playing video messages.
- Having a high-risk or multiple pregnancy.
- Being under 28 weeks or over 32 weeks pregnant.
- Not living with a spouse or partner.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu Provincial Health Directorate
Kastamonu
About this study
Official title: The Effect Of Nursing Care Based On The Transitional Theory Of Meleis On Primiparous Women's Mothering Role Performance and Parent Self-Efficient
Being a mother is a major and developmental life event involving the transition from an existing and known reality to a new unknown reality, in which the woman gains a new role. In the literature, factors such as age, social support, physical and psychosocial well-being, unrealistic positive or negative expectations, and readiness for the role of mother have been stated that affect maternal identity development, maternal self-efficacy and motherhood role performance. In addition, it has been emphasized that some women are especially at risk in this process. Primiparous (first time giving birth) women are among the groups at risk. Being a first-time mother is an important developmental transition in life, and change is an inevitable element of this process. A prompt and sensitive assessment of my antenatal and postnatal needs and appropriate planning of care are key to effectively supporting women in the transition to motherhood. Therefore, it is thought that individualized nursing care based on Transition theory will be a useful conceptual framework for primary women to realize a healthy transition to motherhood. No research has been found in the literature that evaluates the maternal role performance and parental self-efficacy of primiparous women based on a theory. In this direction, it is thought that this study will shed light on the planning of nursing care to be offered during the transition to motherhood, contribute to the nursing literature, women can make a healthy transition to the role of motherhood, and the risks such as unhealthy transition, role inadequacy, adverse effects on mother and baby health will be minimized. The aim of this study is to determine the Effect of Nursing Care Based on Meleis' Transition Theory on the Maternal Role Performance and Parental Self-Efficacy of Primiparous Women.
Read the detailed description
Being a mother is a major and developmental life event that includes the transition from an existing and known reality to a new unknown reality, in which the woman gains a new role. Acquiring the role of motherhood; The development of maternal identity is a transformational transition process that includes women's trust in their interactions with their babies, feeling competent as a mother, internalizing the role of motherhood, and integrating the role of motherhood into other existing roles in life. Transition has been defined as moving from one state, condition or place to another. Transitions involve movement from one state of mind to another that develops over time. While individuals, families or societies experience unfamiliar environments and emotions during transitions, they face uncertainty about what they may experience in the post-transition period.
During the transition to motherhood, women may experience unrealistic positive or negative prenatal expectations, disruptions in their daily lives and routines. As a result of these, it will be inevitable that health and well-being will be negatively affected in this process. While especially negative experiences, insufficient social support, unreliable information, negative criticism and attitudes from the environment, stress, anxiety and depression, and generalized care away from individuality negatively affect the development of motherhood identity, readiness for the role of motherhood, having sufficient information, having social support. Factors such as getting professional support, high self-esteem of the mother also affect the development of motherhood identity and motherhood role performance positively. Schumacher and Meleis reported that mothers adapt more to their post-transition roles with a positive transition period and maternal identity acquisition. At the same time, maternal identity development helps the mother to cope with and manage her negative emotions, to feel empowered and free, and positively affects the psychosocial development of women. In the transition to motherhood, the woman's satisfaction from the role of mother and the feeling of self-sufficiency as a mother are the basic components for the acquisition of the motherhood role. Maternal role acquisition has a significant impact on the quality of parenting behavior and the infant's mental development. Motherhood requires women to combine their previous roles with the parenting role after becoming a mother. Being satisfied with the role of motherhood, mother-infant interaction and healthy transition process together with attachment contribute to the acquisition of a flexible and adaptable identity. In other words, maternal role satisfaction has a great role in adapting to the mother's roles in marriage, work, family, spouse's family and social life, as well as motherhood. Studies have shown that being satisfied with the role of mother and an effective mother-infant interaction with the acquisition of motherhood identity positively affect the cognitive and motor development stages of children, their problem-solving skills and psychosocial development. In another study, it was determined that babies who do not communicate effectively with their mothers and cannot bond securely with their mothers experience social isolation during childhood and adolescence. Mercer stated that a woman's self-confidence in the role of mother and feeling competent as a parent are important in reaching the identity of motherhood. In other words, a healthy transition to motherhood is also affected by mothers' beliefs in their competence to be parents. Knowing how to fulfill a role is insufficient for successful role performance. The individual also needs a sense of competence. Parental efficacy has two important components: self-efficacy and satisfaction. Self-efficacy is a cognitive process in which an individual evaluates their ability to cope with or overcome different situations. Parental self-efficacy is defined as "parents' expectations regarding their ability to parent successfully and a parent's sense of being able to positively influence their child's behavior and development". Negative thoughts and concerns in the process of becoming a mother negatively affect women's parental self-efficacy. The higher the perception of self-efficacy, the more likely the woman is to use new skills, especially when a situation becomes difficult.
In the literature, factors such as age, social support, physical and psychosocial well-being, unrealistic positive or negative expectations, and readiness for the role of mother have been stated that affect maternal identity development, maternal self-efficacy and motherhood role performance. In addition, it has been emphasized that some women are especially at risk in this process. Primiparous (first time giving birth) women are among the groups at risk. Being a first-time mother is an important developmental transition in life, and change is an inevitable element of this process. Studies have shown that in the early postpartum period, primiparous women feel more tired, depressed and have more difficulty in assuming the role of motherhood than multiparous women. In addition, primiparous women have lower maternal role satisfaction and self-efficacy perceptions . Low perceived self-efficacy is a risk factor for antenatal depression. It has also been found that primiparous women feel more fear of labor pain and birth complications and have higher levels of anxiety about the negative attitudes of health professionals. Other difficulties faced by primiparous women during the transition to motherhood in studies include routine care of the baby, inadequacy in infant safety and breastfeeding, increased levels of stress, anxiety and depression, and postpartum functional insufficiency. Qualitative studies focusing on the experiences of primiparous people in the transition to motherhood draw attention to the health care providers who do not spare enough time for themselves and answer their questions, and their dissatisfaction with maternity care, information transfer on baby care and self-care, skills training, and the need for more comprehensive guidance and support from health care professionals.
The transition to motherhood is highly subjective and can be experienced very differently from one woman to another. Therefore, every woman has different physiological and psychological care needs during the transition to motherhood. When these care needs are not met, their physiological and psychological health may be adversely affected. Although nurses are at the center of transition processes, they have a very special position to evaluate the physical and psychosocial needs of individuals who are faced with changes and to provide them with holistic and individual care so that they can complete the transition process in a healthy way. In Meleis' Transition Theory; It has been defined which nursing practices nurses can use so that individuals in transition can experience healthy transitions. According to Meleis, by taking the transition theory as a guide, nurses understand the level of awareness of the individual, the responsibilities to be taken, the change to be experienced, the start and expected end time of the transition, the critical turning points, the impact of the change on daily life, the stages the individual goes through and their reactions at different stages of this process. they care for the individual in this direction. Rapid and sensitive assessment of my prenatal and postnatal needs and appropriate planning of care are key to effectively supporting women in transition to motherhood. Therefore, it is thought that individualized nursing care based on Transition theory will be a useful conceptual framework for primary women to realize a healthy transition to motherhood. No research has been found in the literature that evaluates the maternal role performance and parental self-efficacy of primiparous women based on a theory. In this direction, it is thought that this study will shed light on the planning of nursing care to be offered during the transition to motherhood, contribute to the nursing literature, women can make a healthy transition to the role of motherhood, and the risks such as unhealthy transition, role inadequacy, adverse effects on mother and baby health will be minimized.
- Conditions
- Primiparous Women
- Being tested
- Physical, psychological and spiritual nursing care (Nursing Therapeutics)
- Keywords
- Primiparity, Self Efficacy, Mothers, Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical, psychological and spiritual nursing care (Nursing Therapeutics)Behavioural
- Follow-up: To make a presentation about the physiological and psychological changes during pregnancy. do dream work
- Follow-up: Providing education and counseling for childbirth.
- Follow-up: Training and role rehearsal on mother-infant interaction, breastfeeding and infant care.
- Follow-up: To provide counseling on the issues needed with the approaching of the birth.
- Follow-up: Teaching about conscious parenting and mother-infant, father-infant interaction.
- Tracking. To provide education, counseling and social support on the other roles of the mother in life such as wife role, working woman role, social role.
- Follow-up: To evaluate the transition to motherhood.
- Follow-up: To evaluate the outcomes of transition to motherhood and adjustment to motherhood according to expected completion time.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Participants in the experimental group will receive training and counseling consisting of a total of 8 modules from the 28th week of pregnancy to the fourth month of the postpartum period. Receives: Behavioral: Physical, psychological and spiritual nursing care (Nursing Therapeutics) |
| Control group | No intervention | No educational counseling will be applied to the women in the control group. These participants will receive routine antenatal, natal and postnatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Scale of Being the Structure of a New Baby
With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated.
The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.
Measured: It is applied to both groups on the 7th postpartum day.
The Scale of Being the Structure of a New Baby
With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated.
The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.
Measured: It is applied to both groups on the 1th month.
The Scale of Being the Structure of a New Baby
With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated.
The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.
Measured: It is applied to both groups on the 4th month.
Parental Self-Efficacy Scale
With Parental Self-Efficacy, it will be evaluated whether women feel competent in the role of mother.
It was developed to determine the personal judgments of new parents with their first and only 3-6 month old babies regarding their competencies in the parent role. There are sub-dimensions of Meeting Needs, Parental Competence, Relief of Discomfort, Coping with Illness and Social Interaction. As the score obtained from the scale increases, self-efficacy increases.
Measured: It is applied to both groups on the 4th month.
Secondary outcomes (7)
Edinburgh Postpartum Depression Scale
The scale can be used to determine the risk of depression. The scale consists of 10 items in total. The total score is calculated by assigning a value between 0 and 3 for each item. The cut-off score of the scale for screening was calculated as 12.
Measured: Measurements are made at 28 weeks of gestation for both groups.
Edinburgh Postpartum Depression Scale
The scale can be used to determine the risk of depression. The scale consists of 10 items in total. The total score is calculated by assigning a value between 0 and 3 for each item. The cut-off score of the scale for screening was calculated as 12.
Measured: Measurements are made at 38 weeks of gestation for both groups.
Edinburgh Postpartum Depression Scale
The scale can be used to determine the risk of depression. The scale consists of 10 items in total. The total score is calculated by assigning a value between 0 and 3 for each item. The cut-off score of the scale for screening was calculated as 12.
Measured: Measurements are made at 7th postpartum day for both groups.
Edinburgh Postpartum Depression Scale
The scale can be used to determine the risk of depression. The scale consists of 10 items in total. The total score is calculated by assigning a value between 0 and 3 for each item. The cut-off score of the scale for screening was calculated as 12.
Measured: Measurements are made at 1th postpartum month for both groups.
Edinburgh Postpartum Depression Scale
The scale can be used to determine the risk of depression. The scale consists of 10 items in total. The total score is calculated by assigning a value between 0 and 3 for each item. The cut-off score of the scale for screening was calculated as 12.
Measured: Measurements are made at 4th postpartum month for both groups.
Prenatal Maternity Expectations Scale
It measures prenatal maternal expectations. A total score ranging from 34 to 170 is also obtained from the scale. Accordingly, a high score from the scale represents an unrealistic positive expectation, a low score represents an unrealistic negative expectation, while a moderate score represents a realistic expectation.
Measured: For each group, measurements are made at the 28th gestational week of pregnancy.
Prenatal Maternity Expectations Scale
It measures prenatal maternal expectations. A total score ranging from 34 to 170 is also obtained from the scale. Accordingly, a high score from the scale represents an unrealistic positive expectation, a low score represents an unrealistic negative expectation, while a moderate score represents a realistic expectation.
Measured: For each group, measurements are made at the 36th gestational week of pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Aug 2022
- Primary completion30 Jun 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primiparous WomenStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled Experimental Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Özcan, Ondokuz Mayıs University
- Investigators
- Ebru ÖZCAN, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866588
- Sponsor's protocol ID
- EOzcan
- Status last verified
- Aug 2024
- First submitted
- 1 May 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of the research will be shared with third parties with the research report when the research is concluded and published. If the editor wishes to see the raw data during publication, it will be forwarded to him.
Publications
Mercer RT. Becoming a mother versus maternal role attainment. J Nurs Scholarsh. 2004;36(3):226-32. doi: 10.1111/j.1547-5069.2004.04042.x.
PubMed 15495491Mercer RT, Walker LO. A review of nursing interventions to foster becoming a mother. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):568-82. doi: 10.1111/j.1552-6909.2006.00080.x.
PubMed 16958712Schumacher KL, Meleis AI. Transitions: a central concept in nursing. Image J Nurs Sch. 1994 Summer;26(2):119-27. doi: 10.1111/j.1547-5069.1994.tb00929.x.
PubMed 8063317SmithBattle L, Freed P. Teen Mothers' Mental Health. MCN Am J Matern Child Nurs. 2016 Jan-Feb;41(1):31-6; quiz E3-4. doi: 10.1097/NMC.0000000000000198.
PubMed 26474475Barimani M, Vikstrom A, Rosander M, Forslund Frykedal K, Berlin A. Facilitating and inhibiting factors in transition to parenthood - ways in which health professionals can support parents. Scand J Caring Sci. 2017 Sep;31(3):537-546. doi: 10.1111/scs.12367. Epub 2017 Jan 31.
PubMed 28144992Bassi M, Delle Fave A, Cetin I, Melchiorri E, Pozzo M, Vescovelli F, Ruini C. Psychological well-being and depression from pregnancy to postpartum among primiparous and multiparous women. J Reprod Infant Psychol. 2017 Apr;35(2):183-195. doi: 10.1080/02646838.2017.1290222. Epub 2017 Feb 19.
PubMed 29517362Tsai SS, Wang HH. Role changes in primiparous women during 'doing the month' period. Midwifery. 2019 Jul;74:6-13. doi: 10.1016/j.midw.2019.03.007. Epub 2019 Mar 18.
PubMed 30908975Ozcan E, Temiz S. The impact of nursing care based on transition theory on maternal role performance and parental self-efficacy in primiparous women: a randomized controlled study. BMC Nurs. 2025 Apr 5;24(1):377. doi: 10.1186/s12912-025-03054-4.
PubMed 40188345
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Nursing Care Based On The Transitional Theory Of Meleis On Primiparous Women's Mothering Role Performance and Parent Self-Efficient
- ClinicalTrials.gov ID
- NCT05866588
- Acronym / sponsor ID
- EOzcan
- Conditions
- Primiparous Women
- Keywords
- Primiparity, Self Efficacy, Mothers, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 19 May 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.
Being a mother is a major and developmental life event involving the transition from an existing and known reality to a new unknown reality, in which the woman gains a new role. In the literature, factors such as age, social support, physical and psychosocial well-being, unrealistic positive or negative expectations, and readiness for the role of mother have been stated that affect maternal identity development, maternal self-efficacy and motherhood role performance. In addition, it has been emphasized that some women are especially at risk in this process. Primiparous (first time giving birth) women are among the groups at risk. Being a first-time mother is an important developmental transition in life, and change is an inevitable element of this process. A prompt and sensitive assessment of my antenatal and postnatal needs and appropriate planning of care are key to effectively supporting women in the transition to motherhood. Therefore, it is thought that individualized nursing care based on Transition theory will be a useful conceptual framework for primary women to realize a healthy transition to motherhood. No research has been found in the literature that evaluates the maternal role performance and parental self-efficacy of primiparous women based on a theory. In this direction, it is thought that this study will shed light on the planning of nursing care to be offered during the transition to motherhood, contribute to the nursing literature, women can make a healthy transition to the role of motherhood, and the risks such as unhealthy transition, role inadequacy, adverse effects on mother and baby health will be minimized. The aim of this study is to determine the Effect of Nursing Care Based on Meleis' Transition Theory on the Maternal Role Performance and Parental Self-Efficacy of Primiparous Women.
Detailed description
Being a mother is a major and developmental life event that includes the transition from an existing and known reality to a new unknown reality, in which the woman gains a new role. Acquiring the role of motherhood; The development of maternal identity is a transformational transition process that includes women's trust in their interactions with their babies, feeling competent as a mother, internalizing the role of motherhood, and integrating the role of motherhood into other existing roles in life. Transition has been defined as moving from one state, condition or place to another. Transitions involve movement from one state of mind to another that develops over time. While individuals, families or societies experience unfamiliar environments and emotions during transitions, they face uncertainty about what they may experience in the post-transition period.
During the transition to motherhood, women may experience unrealistic positive or negative prenatal expectations, disruptions in their daily lives and routines. As a result of these, it will be inevitable that health and well-being will be negatively affected in this process. While especially negative experiences, insufficient social support, unreliable information, negative criticism and attitudes from the environment, stress, anxiety and depression, and generalized care away from individuality negatively affect the development of motherhood identity, readiness for the role of motherhood, having sufficient information, having social support. Factors such as getting professional support, high self-esteem of the mother also affect the development of motherhood identity and motherhood role performance positively. Schumacher and Meleis reported that mothers adapt more to their post-transition roles with a positive transition period and maternal identity acquisition. At the same time, maternal identity development helps the mother to cope with and manage her negative emotions, to feel empowered and free, and positively affects the psychosocial development of women. In the transition to motherhood, the woman's satisfaction from the role of mother and the feeling of self-sufficiency as a mother are the basic components for the acquisition of the motherhood role. Maternal role acquisition has a significant impact on the quality of parenting behavior and the infant's mental development. Motherhood requires women to combine their previous roles with the parenting role after becoming a mother. Being satisfied with the role of motherhood, mother-infant interaction and healthy transition process together with attachment contribute to the acquisition of a flexible and adaptable identity. In other words, maternal role satisfaction has a great role in adapting to the mother's roles in marriage, work, family, spouse's family and social life, as well as motherhood. Studies have shown that being satisfied with the role of mother and an effective mother-infant interaction with the acquisition of motherhood identity positively affect the cognitive and motor development stages of children, their problem-solving skills and psychosocial development. In another study, it was determined that babies who do not communicate effectively with their mothers and cannot bond securely with their mothers experience social isolation during childhood and adolescence. Mercer stated that a woman's self-confidence in the role of mother and feeling competent as a parent are important in reaching the identity of motherhood. In other words, a healthy transition to motherhood is also affected by mothers' beliefs in their competence to be parents. Knowing how to fulfill a role is insufficient for successful role performance. The individual also needs a sense of competence. Parental efficacy has two important components: self-efficacy and satisfaction. Self-efficacy is a cognitive process in which an individual evaluates their ability to cope with or overcome different situations. Parental self-efficacy is defined as "parents' expectations regarding their ability to parent successfully and a parent's sense of being able to positively influence their child's behavior and development". Negative thoughts and concerns in the process of becoming a mother negatively affect women's parental self-efficacy. The higher the perception of self-efficacy, the more likely the woman is to use new skills, especially when a situation becomes difficult.
In the literature, factors such as age, social support, physical and psychosocial well-being, unrealistic positive or negative expectations, and readiness for the role of mother have been stated that affect maternal identity development, maternal self-efficacy and motherhood role performance. In addition, it has been emphasized that some women are especially at risk in this process. Primiparous (first time giving birth) women are among the groups at risk. Being a first-time mother is an important developmental transition in life, and change is an inevitable element of this process. Studies have shown that in the early postpartum period, primiparous women feel more tired, depressed and have more difficulty in assuming the role of motherhood than multiparous women. In addition, primiparous women have lower maternal role satisfaction and self-efficacy perceptions . Low perceived self-efficacy is a risk factor for antenatal depression. It has also been found that primiparous women feel more fear of labor pain and birth complications and have higher levels of anxiety about the negative attitudes of health professionals. Other difficulties faced by primiparous women during the transition to motherhood in studies include routine care of the baby, inadequacy in infant safety and breastfeeding, increased levels of stress, anxiety and depression, and postpartum functional insufficiency. Qualitative studies focusing on the experiences of primiparous people in the transition to motherhood draw attention to the health care providers who do not spare enough time for themselves and answer their questions, and their dissatisfaction with maternity care, information transfer on baby care and self-care, skills training, and the need for more comprehensive guidance and support from health care professionals.
The transition to motherhood is highly subjective and can be experienced very differently from one woman to another. Therefore, every woman has different physiological and psychological care needs during the transition to motherhood. When these care needs are not met, their physiological and psychological health may be adversely affected. Although nurses are at the center of transition processes, they have a very special position to evaluate the physical and psychosocial needs of individuals who are faced with changes and to provide them with holistic and individual care so that they can complete the transition process in a healthy way. In Meleis' Transition Theory; It has been defined which nursing practices nurses can use so that individuals in transition can experience healthy transitions. According to Meleis, by taking the transition theory as a guide, nurses understand the level of awareness of the individual, the responsibilities to be taken, the change to be experienced, the start and expected end time of the transition, the critical turning points, the impact of the change on daily life, the stages the individual goes through and their reactions at different stages of this process. they care for the individual in this direction. Rapid and sensitive assessment of my prenatal and postnatal needs and appropriate planning of care are key to effectively supporting women in transition to motherhood. Therefore, it is thought that individualized nursing care based on Transition theory will be a useful conceptual framework for primary women to realize a healthy transition to motherhood. No research has been found in the literature that evaluates the maternal role performance and parental self-efficacy of primiparous women based on a theory. In this direction, it is thought that this study will shed light on the planning of nursing care to be offered during the transition to motherhood, contribute to the nursing literature, women can make a healthy transition to the role of motherhood, and the risks such as unhealthy transition, role inadequacy, adverse effects on mother and baby health will be minimized.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Experimental Design
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Physical, psychological and spiritual nursing care (Nursing Therapeutics)Participants in the experimental group will receive training and counseling consisting of a total of 8 modules from the 28th week of pregnancy to the fourth month of the postpartum period. |
| Control group | No intervention | –No educational counseling will be applied to the women in the control group. These participants will receive routine antenatal, natal and postnatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To agree to participate in the research voluntarily.
- To be able to read and write Turkish.
- Not to have a diagnosed psychiatric disease or communication problem.
- Having a mobile phone capable of receiving and playing video messages.
- Being healthy and having a single pregnancy.
Key exclusion criteria (7 listed)
- Not accepting to participate in the research voluntarily.
- Not being literate in Turkish.
- Having a diagnosed psychiatric illness or communication problem.
- Lack of mobile phone capable of receiving and playing video messages.
- Having a high-risk or multiple pregnancy.
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 |
|---|---|---|
| Physical, psychological and spiritual nursing care (Nursing Therapeutics)1. Follow-up: To make a presentation about the physiological and psychological changes during pregnancy. do dream work 2. Follow-up: Providing education and counseling for childbirth. 3. Follow-up: Training and role rehearsal on mother-infant interaction, breastfeeding and infant care. 4. Follow-up: To provide counseling on the issues needed with the approaching of the birth. 5. Follow-up: Teaching about conscious parenting and mother-infant, father-infant interaction. 6. Tracking. To provide education, counseling and social support on the other roles of the mother in life such as wife role, working woman role, social role. 7. Follow-up: To evaluate the transition to motherhood. 8. Follow-up: To evaluate the outcomes of transition to motherhood and adjustment to motherhood according to expected completion time. | Behavioural | experimental group |
Primary outcome
The Scale of Being the Structure of a New Baby
Time frame: It is applied to both groups on the 7th postpartum day.
With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated. The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.
The Scale of Being the Structure of a New Baby
Time frame: It is applied to both groups on the 1th month.
With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated. The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.
The Scale of Being the Structure of a New Baby
Time frame: It is applied to both groups on the 4th month.
With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated. The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.
Parental Self-Efficacy Scale
Time frame: It is applied to both groups on the 4th month.
With Parental Self-Efficacy, it will be evaluated whether women feel competent in the role of mother. It was developed to determine the personal judgments of new parents with their first and only 3-6 month old babies regarding their competencies in the parent role. There are sub-dimensions of Meeting Needs, Parental Competence, Relief of Discomfort, Coping with Illness and Social Interaction. As the score obtained from the scale increases, self-efficacy increases.
7 secondary outcomes
Edinburgh Postpartum Depression Scale
Time frame: Measurements are made at 28 weeks of gestation for both groups.
Edinburgh Postpartum Depression Scale
Time frame: Measurements are made at 38 weeks of gestation for both groups.
Edinburgh Postpartum Depression Scale
Time frame: Measurements are made at 7th postpartum day for both groups.
Edinburgh Postpartum Depression Scale
Time frame: Measurements are made at 1th postpartum month for both groups.
Edinburgh Postpartum Depression Scale
Time frame: Measurements are made at 4th postpartum month for both groups.
Prenatal Maternity Expectations Scale
Time frame: For each group, measurements are made at the 28th gestational week of pregnancy.
Prenatal Maternity Expectations Scale
Time frame: For each group, measurements are made at the 36th gestational week of pregnancy.
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 19 Aug 2024.
- Results publication: PubMed 15495491Mercer RT. Becoming a mother versus maternal role attainment. J Nurs Scholarsh. 2004;36(3):226-32. doi: 10.1111/j.1547-5069.2004.04042.x.
- Results publication: PubMed 16958712Mercer RT, Walker LO. A review of nursing interventions to foster becoming a mother. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):568-82. doi: 10.1111/j.1552-6909.2006.00080.x.
- Results publication: PubMed 8063317Schumacher KL, Meleis AI. Transitions: a central concept in nursing. Image J Nurs Sch. 1994 Summer;26(2):119-27. doi: 10.1111/j.1547-5069.1994.tb00929.x.
- Results publication: PubMed 26474475SmithBattle L, Freed P. Teen Mothers' Mental Health. MCN Am J Matern Child Nurs. 2016 Jan-Feb;41(1):31-6; quiz E3-4. doi: 10.1097/NMC.0000000000000198.
- Results publication: PubMed 28144992Barimani M, Vikstrom A, Rosander M, Forslund Frykedal K, Berlin A. Facilitating and inhibiting factors in transition to parenthood - ways in which health professionals can support parents. Scand J Caring Sci. 2017 Sep;31(3):537-546. doi: 10.1111/scs.12367. Epub 2017 Jan 31.
- Results publication: PubMed 29517362Bassi M, Delle Fave A, Cetin I, Melchiorri E, Pozzo M, Vescovelli F, Ruini C. Psychological well-being and depression from pregnancy to postpartum among primiparous and multiparous women. J Reprod Infant Psychol. 2017 Apr;35(2):183-195. doi: 10.1080/02646838.2017.1290222. Epub 2017 Feb 19.
- Results publication: PubMed 30908975Tsai SS, Wang HH. Role changes in primiparous women during 'doing the month' period. Midwifery. 2019 Jul;74:6-13. doi: 10.1016/j.midw.2019.03.007. Epub 2019 Mar 18.
- Derived from this study: PubMed 40188345Ozcan E, Temiz S. The impact of nursing care based on transition theory on maternal role performance and parental self-efficacy in primiparous women: a randomized controlled study. BMC Nurs. 2025 Apr 5;24(1):377. doi: 10.1186/s12912-025-03054-4.
- Individual participant dataSharing planned: Yes. The data of the research will be shared with third parties with the research report when the research is concluded and published. If the editor wishes to see the raw data during publication, it will be forwarded to him.
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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.
Ebru ÖZCAN study director
Ondokuz Mayıs 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 Physical, psychological and spiritual nursing care (Nursing Therapeutics) in people with Primiparous Women, run by Ondokuz Mayıs 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 7 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 19 Aug 2024. 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?
The Scale of Being the Structure of a New Baby (time frame: It is applied to both groups on the 7th postpartum day.). 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 NCT05866588, which also lists 8 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 19 Aug 2024.