NewbornNCT04827849
Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby
A study testing Structured education and follow-up in people with Newborn and Prenatal Care, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
A randomised control trial will made to determine the effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn, Prenatal Care, Nursing Caries
- What is being tested?
- Structured education and follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 19 Aug 2022
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in Aydın
- Between the ages of 18-35
- Have no children
- Gestational week is 28 weeks (beginning of 3rd trimester)
- Having a single pregnancy
- At least primary school graduate
Show all 9Show fewer
- Not risky of pregnancy
- Have no chronic disease
- Can speak and write Turkish language
Who cannot join
- Having a history of mental and mental health problems
- With speech and hearing impairments
- Having a risky pregnancy
- Having multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
Aydin
About this study
Official title: The Effect of Nursing Care Based on Transition Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby
A randomised control trial will made to determine the effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant
Read the detailed description
Transition to motherhood, being one of the most important life incidents in the lives of women embodies the transition of role from a known situation to an unknown one. Being a special period in which women hold the role of motherhood together with the birth of the child; try to adapt the new role and reform relationship with the family members at the same time, transition to motherhood is a progressive period experienced by many women. Transition of woman to motherhood in a healthy manner will positively affect developing trust, achieving healthy communication with the infant, adapting to new lifestyle and fulfilling her responsibilities. Thus, transition to motherhood is quite significant both for mother and other family members and the new-born infant and needs to be discussed.
It is aimed in this research that effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant shall be tested.
It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of adaptation to pregnancy, adaptation to the postpartum period and newborn perception.
- Conditions
- Newborn, Prenatal Care, Nursing Caries
- Being tested
- Structured education and follow-up
- Keywords
- Nursing care, Prenatal, Newborn, Postpartum, Theory, Transition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured education and follow-upOther
The women in the intervention groups will administer a seven-session intervention program in addition to the routine care they will receive.
The training including preparation practices for the transition with the mother, which is planned to last for 7 weeks encompassed providing the women with an educational programme that were created to increasing women's adaptation to motherhood and perceptions of newborn baby
Nursing-recommended follow-up and physical examination of the pregnant woman will be performed at 28th and 34th week of pregnancy. In addition, postpartum and newborn follow-up, and mother-newborn physical examinations will be performed at the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | The study group will be provided physical examination, pregnancy monitoring and training on transition to motherhood within the direction of nursing care based on Meleis's Transition Period Theory, in addition to the usual care provided by healthcare professionals. Receives: Other: Structured education and follow-up |
| Control group | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptasion with pregnancy before intervention
Adaptasion with pregnancy period will be evaluated with "Prenatal Self Evaluation Questionnaire".
The scale was developed (1979) in order to evaluate the adaptation of women in the prenatal period to motherhood. The scale has 7 sub-dimensions. For the whole scale, a minimum of 79 and a maximum of 316 points can be obtained. Low scores show that adjustment to pregnancy is high.
Measured: 28th gestational weeks
Adaptasion with pregnancy after intervention
The "Prenatal Self Evaluation Questionnaire" will be used to compare the fits to pregnancy between 28th and 34th weeks of gestation.
The scale was developed (1979) in order to evaluate the adaptation of women in the prenatal period to motherhood. The scale has 7 sub-dimensions. For the whole scale, a minimum of 79 and a maximum of 316 points can be obtained. Low scores show that adjustment to pregnancy is high.
Measured: 34th gestational weeks
Mother-Neonatal Perception after birth
Neonatal Perception Inventory (NPI-I) will be used to determine maternal- newborn perception.
The scale was developed in 1971 to measure mothers' perception of their babies. It consists of two parts: the Neonatal Perception Inventory (NPI-I), applied in the first days after birth, and the NPI-II, administered one month after birth. In NPI-I and II of the scale, there are "Any Baby" and "Your Baby" forms, each containing six items (behaviors such as crying, feeding, sleeping, vomiting / drooling, pooping, eating and sleeping habits). It consists of 5-point Likert type 24 items.
Measured: 3rd - 5th day after the birth
Mother-Neonatal Perception after birth
Neonatal Perception Inventory (NPI-II) will be used to determine maternal- newborn perception.
The scale was developed in 1971 to measure mothers' perception of their babies. It consists of two parts: the Neonatal Perception Inventory (NPI-I), applied in the first days after birth, and the NPI-II, administered one month after birth. In NPI-I and II of the scale, there are "Any Baby" and "Your Baby" forms, each containing six items (behaviors such as crying, feeding, sleeping, vomiting / drooling, pooping, eating and sleeping habits). It consists of 5-point Likert type 24 items.
Measured: 1st month after the birth
Adaptasion to the postpartum period
The scale was developed (1981) to evaluate the adaptation of women in postpartum period to motherhood and is a 4-point Likert type with 82 items. There are 7 subscales that evaluate postpartum compliance of mothers. For the whole scale, a minimum of 82 and a maximum of 328 points can be obtained. Low scores indicate high postpartum adjustment.
Measured: 1st month after the birth
Adaptasion to the postpartum period
The scale was developed (1981) to evaluate the adaptation of women in postpartum period to motherhood and is a 4-point Likert type with 82 items. There are 7 subscales that evaluate postpartum compliance of mothers. For the whole scale, a minimum of 82 and a maximum of 328 points can be obtained. Low scores indicate high postpartum adjustment.
Measured: 4th month after the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Sep 2020
- Primary completion30 Mar 2021
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Yeşilfidan, Aydin Adnan Menderes University
- Investigators
- Duygu Yeşilfidan, MsC, Study chair, Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827849
- Sponsor's protocol ID
- Duygu YEŞİLFİDAN, Filiz ADANA
- Status last verified
- Jun 2023
- First submitted
- 30 Mar 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Based on Transition Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby
- ClinicalTrials.gov ID
- NCT04827849
- Acronym / sponsor ID
- Duygu YEŞİLFİDAN, Filiz ADANA
- Conditions
- Newborn, Prenatal Care, Nursing Caries
- Keywords
- Nursing care, Prenatal, Newborn, Postpartum, Theory, Transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 1 Apr 2021 (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.
A randomised control trial will made to determine the effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant
Detailed description
Transition to motherhood, being one of the most important life incidents in the lives of women embodies the transition of role from a known situation to an unknown one. Being a special period in which women hold the role of motherhood together with the birth of the child; try to adapt the new role and reform relationship with the family members at the same time, transition to motherhood is a progressive period experienced by many women. Transition of woman to motherhood in a healthy manner will positively affect developing trust, achieving healthy communication with the infant, adapting to new lifestyle and fulfilling her responsibilities. Thus, transition to motherhood is quite significant both for mother and other family members and the new-born infant and needs to be discussed.
It is aimed in this research that effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant shall be tested.
It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of adaptation to pregnancy, adaptation to the postpartum period and newborn perception.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Other: Structured education and follow-upThe study group will be provided physical examination, pregnancy monitoring and training on transition to motherhood within the direction of nursing care based on Meleis's Transition Period Theory, in addition to the usual care provided by healthcare professionals. |
| Control group | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Living in Aydın
- Between the ages of 18-35
- Have no children
- Gestational week is 28 weeks (beginning of 3rd trimester)
- Having a single pregnancy
Key exclusion criteria (4 listed)
- Having a history of mental and mental health problems
- With speech and hearing impairments
- Having a risky pregnancy
- Having multiple pregnancies
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 |
|---|---|---|
| Structured education and follow-upThe women in the intervention groups will administer a seven-session intervention program in addition to the routine care they will receive. The training including preparation practices for the transition with the mother, which is planned to last for 7 weeks encompassed providing the women with an educational programme that were created to increasing women's adaptation to motherhood and perceptions of newborn baby Nursing-recommended follow-up and physical examination of the pregnant woman will be performed at 28th and 34th week of pregnancy. In addition, postpartum and newborn follow-up, and mother-newborn physical examinations will be performed at the postpartum period. | Other | Experiment group |
Primary outcome
Adaptasion with pregnancy before intervention
Time frame: 28th gestational weeks
Adaptasion with pregnancy period will be evaluated with "Prenatal Self Evaluation Questionnaire". The scale was developed (1979) in order to evaluate the adaptation of women in the prenatal period to motherhood. The scale has 7 sub-dimensions. For the whole scale, a minimum of 79 and a maximum of 316 points can be obtained. Low scores show that adjustment to pregnancy is high.
Adaptasion with pregnancy after intervention
Time frame: 34th gestational weeks
The "Prenatal Self Evaluation Questionnaire" will be used to compare the fits to pregnancy between 28th and 34th weeks of gestation. The scale was developed (1979) in order to evaluate the adaptation of women in the prenatal period to motherhood. The scale has 7 sub-dimensions. For the whole scale, a minimum of 79 and a maximum of 316 points can be obtained. Low scores show that adjustment to pregnancy is high.
Mother-Neonatal Perception after birth
Time frame: 3rd - 5th day after the birth
Neonatal Perception Inventory (NPI-I) will be used to determine maternal- newborn perception. The scale was developed in 1971 to measure mothers' perception of their babies. It consists of two parts: the Neonatal Perception Inventory (NPI-I), applied in the first days after birth, and the NPI-II, administered one month after birth. In NPI-I and II of the scale, there are "Any Baby" and "Your Baby" forms, each containing six items (behaviors such as crying, feeding, sleeping, vomiting / drooling, pooping, eating and sleeping habits). It consists of 5-point Likert type 24 items.
Mother-Neonatal Perception after birth
Time frame: 1st month after the birth
Neonatal Perception Inventory (NPI-II) will be used to determine maternal- newborn perception. The scale was developed in 1971 to measure mothers' perception of their babies. It consists of two parts: the Neonatal Perception Inventory (NPI-I), applied in the first days after birth, and the NPI-II, administered one month after birth. In NPI-I and II of the scale, there are "Any Baby" and "Your Baby" forms, each containing six items (behaviors such as crying, feeding, sleeping, vomiting / drooling, pooping, eating and sleeping habits). It consists of 5-point Likert type 24 items.
Adaptasion to the postpartum period
Time frame: 1st month after the birth
The scale was developed (1981) to evaluate the adaptation of women in postpartum period to motherhood and is a 4-point Likert type with 82 items. There are 7 subscales that evaluate postpartum compliance of mothers. For the whole scale, a minimum of 82 and a maximum of 328 points can be obtained. Low scores indicate high postpartum adjustment.
Adaptasion to the postpartum period
Time frame: 4th month after the birth
The scale was developed (1981) to evaluate the adaptation of women in postpartum period to motherhood and is a 4-point Likert type with 82 items. There are 7 subscales that evaluate postpartum compliance of mothers. For the whole scale, a minimum of 82 and a maximum of 328 points can be obtained. Low scores indicate high postpartum adjustment.
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 22 Jun 2023.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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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.
Duygu Yeşilfidan, MsC study chair
Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured education and follow-up in people with Newborn and Prenatal Care, run by Aydin Adnan Menderes 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 9 inclusion and 4 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 22 Jun 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?
Adaptasion with pregnancy before intervention (time frame: 28th gestational weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.