NCT05866588

Brief Summary

Being a mother is a major and developmental life event involving the transition from an existing and known reality to a new unknown reality, in which the woman gains a new role. In the literature, factors such as age, social support, physical and psychosocial well-being, unrealistic positive or negative expectations, and readiness for the role of mother have been stated that affect maternal identity development, maternal self-efficacy and motherhood role performance. In addition, it has been emphasized that some women are especially at risk in this process. Primiparous (first time giving birth) women are among the groups at risk. Being a first-time mother is an important developmental transition in life, and change is an inevitable element of this process. A prompt and sensitive assessment of my antenatal and postnatal needs and appropriate planning of care are key to effectively supporting women in the transition to motherhood. Therefore, it is thought that individualized nursing care based on Transition theory will be a useful conceptual framework for primary women to realize a healthy transition to motherhood. No research has been found in the literature that evaluates the maternal role performance and parental self-efficacy of primiparous women based on a theory. In this direction, it is thought that this study will shed light on the planning of nursing care to be offered during the transition to motherhood, contribute to the nursing literature, women can make a healthy transition to the role of motherhood, and the risks such as unhealthy transition, role inadequacy, adverse effects on mother and baby health will be minimized. The aim of this study is to determine the Effect of Nursing Care Based on Meleis' Transition Theory on the Maternal Role Performance and Parental Self-Efficacy of Primiparous Women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

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

August 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

May 1, 2023

Last Update Submit

August 16, 2024

Conditions

Keywords

PrimiparitySelf EfficacyMothersParenting

Outcome Measures

Primary Outcomes (4)

  • The Scale of Being the Structure of a New Baby

    With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated. The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.

    It is applied to both groups on the 7th postpartum day.

  • The Scale of Being the Structure of a New Baby

    With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated. The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.

    It is applied to both groups on the 1th month.

  • The Scale of Being the Structure of a New Baby

    With the Maternity Role Performance, women's evaluation of their motherhood experiences, their satisfaction with the motherhood role and their perception of life changes will be evaluated. The measurement is made to reveal the qualitative aspects of the mother related to being the mother of a new baby. The score distribution of the scale is between 17-153. It has 2 sub-dimensions. Each sub-dimension is evaluated within itself.

    It is applied to both groups on the 4th month.

  • Parental Self-Efficacy Scale

    With Parental Self-Efficacy, it will be evaluated whether women feel competent in the role of mother. It was developed to determine the personal judgments of new parents with their first and only 3-6 month old babies regarding their competencies in the parent role. There are sub-dimensions of Meeting Needs, Parental Competence, Relief of Discomfort, Coping with Illness and Social Interaction. As the score obtained from the scale increases, self-efficacy increases.

    It is applied to both groups on the 4th month.

Secondary Outcomes (7)

  • Edinburgh Postpartum Depression Scale

    Measurements are made at 28 weeks of gestation for both groups.

  • Edinburgh Postpartum Depression Scale

    Measurements are made at 38 weeks of gestation for both groups.

  • Edinburgh Postpartum Depression Scale

    Measurements are made at 7th postpartum day for both groups.

  • Edinburgh Postpartum Depression Scale

    Measurements are made at 1th postpartum month for both groups.

  • Edinburgh Postpartum Depression Scale

    Measurements are made at 4th postpartum month for both groups.

  • +2 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

Participants in the experimental group will receive training and counseling consisting of a total of 8 modules from the 28th week of pregnancy to the fourth month of the postpartum period.

Behavioral: Physical, psychological and spiritual nursing care (Nursing Therapeutics)

Control group

NO INTERVENTION

No educational counseling will be applied to the women in the control group. These participants will receive routine antenatal, natal and postnatal care

Interventions

1. Follow-up: To make a presentation about the physiological and psychological changes during pregnancy. do dream work 2. Follow-up: Providing education and counseling for childbirth. 3. Follow-up: Training and role rehearsal on mother-infant interaction, breastfeeding and infant care. 4. Follow-up: To provide counseling on the issues needed with the approaching of the birth. 5. Follow-up: Teaching about conscious parenting and mother-infant, father-infant interaction. 6. Tracking. To provide education, counseling and social support on the other roles of the mother in life such as wife role, working woman role, social role. 7. Follow-up: To evaluate the transition to motherhood. 8. Follow-up: To evaluate the outcomes of transition to motherhood and adjustment to motherhood according to expected completion time.

experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To agree to participate in the research voluntarily.
  • To be able to read and write Turkish.
  • Not to have a diagnosed psychiatric disease or communication problem.
  • Having a mobile phone capable of receiving and playing video messages.
  • Being healthy and having a single pregnancy.
  • To be between 28-32 weeks of pregnancy.
  • Living with a spouse or partner.

You may not qualify if:

  • Not accepting to participate in the research voluntarily.
  • Not being literate in Turkish.
  • Having a diagnosed psychiatric illness or communication problem.
  • Lack of mobile phone capable of receiving and playing video messages.
  • Having a high-risk or multiple pregnancy.
  • Being under 28 weeks or over 32 weeks pregnant.
  • Not living with a spouse or partner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu Provincial Health Directorate

Kastamonu, Turkey (Türkiye)

Location

Related Publications (8)

  • Mercer RT. Becoming a mother versus maternal role attainment. J Nurs Scholarsh. 2004;36(3):226-32. doi: 10.1111/j.1547-5069.2004.04042.x.

  • Mercer RT, Walker LO. A review of nursing interventions to foster becoming a mother. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):568-82. doi: 10.1111/j.1552-6909.2006.00080.x.

  • Schumacher KL, Meleis AI. Transitions: a central concept in nursing. Image J Nurs Sch. 1994 Summer;26(2):119-27. doi: 10.1111/j.1547-5069.1994.tb00929.x.

  • SmithBattle L, Freed P. Teen Mothers' Mental Health. MCN Am J Matern Child Nurs. 2016 Jan-Feb;41(1):31-6; quiz E3-4. doi: 10.1097/NMC.0000000000000198.

  • Barimani M, Vikstrom A, Rosander M, Forslund Frykedal K, Berlin A. Facilitating and inhibiting factors in transition to parenthood - ways in which health professionals can support parents. Scand J Caring Sci. 2017 Sep;31(3):537-546. doi: 10.1111/scs.12367. Epub 2017 Jan 31.

  • Bassi M, Delle Fave A, Cetin I, Melchiorri E, Pozzo M, Vescovelli F, Ruini C. Psychological well-being and depression from pregnancy to postpartum among primiparous and multiparous women. J Reprod Infant Psychol. 2017 Apr;35(2):183-195. doi: 10.1080/02646838.2017.1290222. Epub 2017 Feb 19.

  • Tsai SS, Wang HH. Role changes in primiparous women during 'doing the month' period. Midwifery. 2019 Jul;74:6-13. doi: 10.1016/j.midw.2019.03.007. Epub 2019 Mar 18.

  • Ozcan E, Temiz S. The impact of nursing care based on transition theory on maternal role performance and parental self-efficacy in primiparous women: a randomized controlled study. BMC Nurs. 2025 Apr 5;24(1):377. doi: 10.1186/s12912-025-03054-4.

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Ebru ÖZCAN

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Experimental Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 19, 2023

Study Start

August 15, 2022

Primary Completion

June 30, 2023

Study Completion

March 15, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The data of the research will be shared with third parties with the research report when the research is concluded and published. If the editor wishes to see the raw data during publication, it will be forwarded to him.

Shared Documents
CSR
Time Frame
Data available after research is published
Access Criteria
The research can be accessed according to the journal in which it was published.

Locations