NCT05272527

Brief Summary

It has been seen that primiparous pregnant women experience similar problems during the transition to motherhood, and these problems affect both their self-evaluation, physical problems in the postpartum period, and maternal attachment. It is thought that the correct and adequate care and training received from health professionals will be effective in the solution of all these interconnected situations. The study aims to determine the effect of the "Transition to Motherhood Program (TMOP)" applied to primiparous pregnant women on self-assessment, postpartum problems, and maternal attachment. MethoThis research method is a randomized, control group pretest-posttest experimental research. The population of the study consisted of pregnant women who were registered to two Family Health Centers between December 2019 and December 2021 and met the inclusion criteria, the sample consisted who agreed to participate in the study (experimental group: 38, control group: 38).In the study, Personal Information Form, Prenatal Self-Assessment Scale, Prenatal Attachment Scale were applied to all pregnant women in the sample group as pre-test applications. Based on Meleis' Transition Theory, the Transition to Motherhood Program was applied to the pregnant women in the experimental group. The post-test application of the research was carried out in the sixth weeks and fourth postpartum months. At the sixth week of the postpartum period, the Postpartum Self-Assessment Scale, Postpartum Physical Symptom Scale, Maternal Attachment Scale; at the fourth month of the postpartum period, the Maternal Attachment Scale was used. In data analysis, dependent sample t test, ki square, mann whitney u tests will use. Necessary permissions were obtained for the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Dec 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

December 28, 2021

Last Update Submit

March 23, 2022

Conditions

Keywords

Pregnancytransition to motherhoodpostpartum problemsmaternal attachment

Outcome Measures

Primary Outcomes (5)

  • Prenatal Self-Assessment Scale-pretest

    The Scale was developed by Lederman to evaluate the adaptation of women in the prenatal period to pregnancy and the role of motherhood. It hasa 79-item, 4-point Likert-type scale, and has 7 subscales. Subscales are "acceptance of pregnancy", "acceptance of the role of motherhood", "relationship with her own mother", "relationship with her spouse", "readiness for birth", "fear of birth", "thoughts about her own and her baby's health". Low scores indicate high compliance with pregnancy.

    3 month

  • Prenatal Attachment Inventory-pretest

    The Cronbach alpha coefficient of the scale, which was developed by Muller and Mercer (1993) to explain the thoughts, feelings and situations experienced by women during pregnancy, and to determine the level of attachment to the baby in the prenatal period, is 0.86 (Muller and Mercer, 1993). The validity and reliability study of the Turkish version of the PCI was performed by Yılmaz and Beji (2013), and the Cronbach alpha reliability coefficient was found to be 0.84 (Yılmaz \& Beji, 2013). The scale consists of 21 items; Each item is of a four-point Likert type, with a score between 1 and 4. A minimum of 21 points and a maximum of 84 points can be obtained from the scale. The increase in the score obtained by the pregnant indicates that the level of attachment also increases. It is scored as 1: Never, 2: Sometimes, 3: Often, 4: Always. The increase in the score obtained by the pregnant indicates that the level of prenatal attachment also increases.

    3 month

  • Postpartum Self-Assessment Scale-posttest

    It is an 82-item, 4-point Likert-type scale developed by Lederman and Weingarten in 1981 to evaluate postpartum women's adjustment to motherhood. The scale has 7 subscales that evaluate postpartum adjustment of mothers. Subscales are "the quality of the relationship between the partners", "the partners' view of participation in baby care", "satisfaction with the birth experience", "satisfaction with the continuation of life", "confidence in coping with maternal duties", "satisfaction with motherhood and newborn care", "support of family and friends for motherhood". Low scores indicate high postpartum adjustment.

    6 month

  • Postpartum Physical Symptom Severity Scale-posttest

    The scale, developed to determine the prevalence and persistence of postpartum physical symptoms, is a 4-point Likert-type scale with a total of 18 items. "Perineal pain"," insomnia", "constipation", "back pain", "headache", "hemorrhoids", "joint pain", "hand numbness", "vaginal discharge and infection", "foot numbness", "vaginal bleeding"," urinary tract infection"," dizziness", "varicose veins in the legs", "urinary incontinence" occurring in the postpartum period assesses physical symptoms and their severity. The scale has no cut-off point and an increase in the score from the scale indicates that the severity of postpartum physical symptoms is high.

    6 month

  • Maternal Attachment Scale-1st posttest

    The scale developed by Muller (1994); It is applied to women who have babies between one and four months postpartum to determine maternal feelings and behaviors. The scale which measures maternal emotions and behaviors showing love, is a scale that can be applied to women who can read and write and understand what they read, as it is a self-administered scale. The scale consists of 26 questions with 4-point Likert type. All questions contain answers ranging from 'always' to 'never'; It is calculated as Always (a)=4, Often (b)=3, Sometimes (c)=2, and Never (d)=1 points. From the sum of the questions; The lowest score to be obtained varies between 26 and the highest score ranges from 104.

    6 month

Secondary Outcomes (1)

  • Maternal Attachment Scale- 2nd posttest

    9 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

After the pre-tests were completed, the pregnant women were divided into experimental and control groups. Within the scope of the Transition to Motherhood Program, 5-session training and phone follow-ups were made in the first week and the fourth week postpartum to the experimental group. Post-tests were applied to the experimental group at the postpartum 1st month and 4th month.

Behavioral: Transition to Motherhood Program

Control Group

NO INTERVENTION

After the pre-tests were completed, the pregnant women were divided into experimental and control groups. Pretest and postpartum 1st month and 4th month posttests were applied to the control group.

Interventions

Transition to Motherhood program includes 5 sessions. The first session covers the pregnancy process, the second session deals with the birth process, the third session deals with the postpartum period, the fourth session deals with infant care, and the fifth session deals with breast milk and breastfeeding and immunity. Trainings are online. In addition to the lecture technique, the training includes auxiliary techniques such as models, videos, case studies, training cards, and applied demonstrations. The program was completed by telephone follow-up in the first and fourth weeks postpartum.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Not being a multiple and risky pregnancy (healthy pregnant women were selected to understand the effectiveness of the training program),
  • Being over the age of 18, under the age of 35 (this age range has been chosen since pregnancies younger than 18 and older than 35 are considered risky pregnancies),
  • Being the first pregnancy (women who had no previous pregnancy experience were selected to better understand the effectiveness of the training),
  • Being in the 24th week of pregnancy (pregnant women in this week have been selected to make it clear that the pregnancy is not risky),
  • Being literate,
  • Using a smart phone and not having internet access problems (required as the trainings will be held online),
  • Not having a chronic disease,
  • Not having a communication barrier and being willing to participate in the study,
  • Not going to pregnant schools (this criterion has been set so that it does not affect the educational effectiveness).

You may not qualify if:

  • Having a risky pregnancy,
  • Previous pregnancy,
  • More than 24 weeks of gestation,
  • Presence of a chronic disease,
  • Being illiterate,
  • Pregnancy with assisted reproductive techniques,
  • Not having a smart phone and/or having internet access problems,
  • Going to maternity school or getting any training related to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek ÇELİK EREN

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (6)

  • Lederman RP, Lederman E, Work BA Jr, McCann DS. Relationship of psychological factors in pregnancy to progress in labor. Nurs Res. 1979 Mar-Apr;28(2):94-7.

    PMID: 254068BACKGROUND
  • Muller ME. Development of the Prenatal Attachment Inventory. West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5. doi: 10.1177/019394599301500205. No abstract available.

    PMID: 8470375BACKGROUND
  • Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.

    PMID: 7780768BACKGROUND
  • Chien LY, Tai CJ, Hwang FM, Huang CM. Postpartum physical symptoms and depressive symptomatology at 1 month and 1 year after delivery: a longitudinal questionnaire survey. Int J Nurs Stud. 2009 Sep;46(9):1201-8. doi: 10.1016/j.ijnurstu.2009.02.007. Epub 2009 Mar 10.

    PMID: 19278680BACKGROUND
  • Perinatal parental behavior: nursing research and implications for newborn health. Birth Defects Orig Artic Ser. 1981;17(6):1-308. No abstract available.

    PMID: 7326368BACKGROUND
  • Celik Eren D, Aydin Avci I. The Impact of a Transition to Motherhood Program on Postpartum Outcomes of Primiparous Women: A Randomized Controlled Trial. Matern Child Health J. 2025 Nov;29(11):1610-1620. doi: 10.1007/s10995-025-04181-9. Epub 2025 Sep 25.

Study Officials

  • İlknur AYDIN AVCİ, Prof. Dr.

    Ondokuz Mayıs University

    STUDY DIRECTOR
  • Mustafa Kürşat ŞAHİN, Assoc Prof.

    Ondokuz Mayıs University

    STUDY CHAIR
  • Oya Sevcan ORAK, Asist Prof

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Nursing Department

Study Record Dates

First Submitted

December 28, 2021

First Posted

March 9, 2022

Study Start

December 1, 2019

Primary Completion

November 1, 2021

Study Completion

December 23, 2021

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations