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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04827849
Other study ID # Duygu YESILFIDAN, Filiz ADANA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 19, 2022

Study information

Verified date June 2023
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date August 19, 2022
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Living in Aydin - 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Structured education and follow-up
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.

Locations

Country Name City State
Turkey AydinAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing Aydin

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
28th gestational weeks
Primary 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.
34th gestational weeks
Primary 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.
3rd - 5th day after the birth
Primary 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.
1st month after the birth
Primary 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. 1st month after the birth
Primary 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. 4th month after the birth
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