- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827849
Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby
The Effect of Nursing Care Based on Transition Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aydın, Turkey
- AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- Not risky of pregnancy
- Have no chronic disease
- Can speak and write Turkish language
Exclusion Criteria:
- Having a history of mental and mental health problems
- With speech and hearing impairments
- Having a risky pregnancy
- Having multiple pregnancies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experiment group
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.
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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. |
No Intervention: Control group
The control group continued to receive the routine care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adaptasion with pregnancy before intervention
Time Frame: 28th gestational weeks
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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. |
28th gestational weeks
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Adaptasion with pregnancy after intervention
Time Frame: 34th gestational weeks
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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. |
34th gestational weeks
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Mother-Neonatal Perception after birth
Time Frame: 3rd - 5th day after the birth
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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. |
3rd - 5th day after the birth
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Mother-Neonatal Perception after birth
Time Frame: 1st month after the birth
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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. |
1st month after the birth
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Adaptasion to the postpartum period
Time Frame: 1st month after the birth
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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.
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1st month after the birth
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Adaptasion to the postpartum period
Time Frame: 4th month after the birth
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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.
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4th month after the birth
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Duygu Yeşilfidan, MsC, Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Duygu YEŞİLFİDAN, Filiz ADANA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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