Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby

June 21, 2023 updated by: Duygu Yeşilfidan, Aydin Adnan Menderes University

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aydın, Turkey
        • AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

28th gestational weeks
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.

34th gestational weeks
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.

3rd - 5th day after the birth
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.

1st month after the birth
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.
1st month after the birth
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.
4th month after the birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Duygu Yeşilfidan, MsC, Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Duygu YEŞİLFİDAN, Filiz ADANA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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