NCT04827849

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

March 30, 2021

Last Update Submit

June 21, 2023

Conditions

Keywords

Nursing carePrenatalNewbornPostpartumTheoryTransition

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

Other: Structured education and follow-up

Control group

NO INTERVENTION

The control group continued to receive the routine care

Interventions

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.

Experiment group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Having a history of mental and mental health problems
  • With speech and hearing impairments
  • Having a risky pregnancy
  • Having multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing

Aydin, Turkey (Türkiye)

Location

Study Officials

  • Duygu Yeşilfidan, MsC

    Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

September 1, 2020

Primary Completion

March 30, 2021

Study Completion

August 19, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations