The Meleis Theory on Postpartum Depression, Breastfeeding, and Maternal Self-Efficacy in Women Experiencing Preterm Birth

NCT ID: NCT06250933

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2024-09-26

Brief Summary

The aim of this study was to evaluate the effect of a nursing approach based on Meleis' Transition Theory on postpartum depression, maternal self-efficacy and breastfeeding self-efficacy in women who gave birth preterm. The randomized controlled study was conducted in the Neonatal Intensive Care Unit. The study sample consisted of preterm women who volunteered to participate in the study and met the inclusion criteria. A training guide was prepared within the scope of the nursing approach based on Transition Theory. After the theoretical training in the second week after delivery, the intervention group received counseling through face-to-face and telephone individual interviews, while the control group received routine care only in the hospital. Scales were administered to women in both groups at the first interview, 2 weeks later and on day 42.

Detailed Description

The study will be conducted in the Maternity Hospital and Level 3 Neonatal Intensive Care Unit (NICU) of a hospital in Turkey. Ethical principles were taken into consideration in the study. After the necessary arrangements were made in the data collection forms, the participants were given written and verbal explanations about the study and their informed consent was obtained. Data collection forms were applied individually through face-to-face interviews with women who volunteered to participate in the study. training and counseling were provided within the scope of nursing approach. In this context, training consisting of three sessions of 100 minutes in total was given and counseling was provided in the following weeks by conducting 3-4 interviews by phone. In the interviews, counseling was provided on the issues that women needed, especially the difficulties they faced in the postpartum period, postpartum depression symptoms, self-care, breastfeeding problems and maternal self-efficacy. During this period, the women were evaluated with the Breastfeeding Self-Efficacy Scale, the Perceived Maternal Self-Efficacy Scale and the Edinburgh Postnatal Depression Scale three times in total: the first week postpartum (pre-test), two weeks postpartum (post-test 1) and 42 days (week 6) (post-test 2). No intervention other than routine hospital practices was performed on these women. Personal data form, Breastfeeding Self-Efficacy Scale, Perceived Maternal Self-Efficacy Scale, and Edinburgh Postpartum Depression Scale were administered at initial admission. Two weeks after birth and on day 42, the Breastfeeding Self-Efficacy Scale, Perceived Maternal Self-Efficacy Scale and Edinburgh Postpartum Depression Scale were administered again, and then a training booklet on the nursing approach based on the Meleis Transition Theory was given.

Conditions

Premature Birth; Theory, Double Bind; Postpartum Depression; Breast Feeding; Self Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Experiment group

In the intervention group, training and counseling were provided within the scope of the nursing approach based on Meleis transition theory. In this context, training consisting of three sessions of 100 minutes in total was given and counseling was provided by conducting 3-4 interviews by phone in the following weeks. In the interviews, counseling was provided on the issues that women needed, especially the difficulties they faced in the postpartum period, postpartum depression symptoms, self-care, breastfeeding problems and maternal self-efficacy. In this process, the women were evaluated three times in total, in the first postpartum week (pre-test), two weeks after delivery (post-test 1) and 42nd day (6th week) (post-test 2) with the Breastfeeding Self-Efficacy Scale, Perceived Maternal Self-Efficacy Scale and Edinburgh Postpartum Depression Scale.

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Group Type: EXPERIMENTAL

Postpartum Maternal Care and Premature Infant Care Training

Intervention Type: OTHER

Training and counseling were provided. In this context, training consisting of three sessions of 100 minutes in total was provided and counseling was provided in the following weeks by conducting 3-4 telephone interviews.

The intervention involves the provision of a training and counseling program designed to increase women's breastfeeding and maternal self-efficacy and reduce the risk of postpartum depression.

In the training phase, women will receive training on postpartum maternal care and premature infant care.

Control group

The control group will continue to receive routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Postpartum Maternal Care and Premature Infant Care Training

Training and counseling were provided. In this context, training consisting of three sessions of 100 minutes in total was provided and counseling was provided in the following weeks by conducting 3-4 telephone interviews.

The intervention involves the provision of a training and counseling program designed to increase women's breastfeeding and maternal self-efficacy and reduce the risk of postpartum depression.

In the training phase, women will receive training on postpartum maternal care and premature infant care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Willing to participate in the study
• Without communication barriers
• Literate
• Married
• Not undergoing psychological treatment
• Preterm birth occurring between gestational weeks 28-32
• Mothers of preterm infants receiving continuous treatment in the NICU (Neonatal Intensive Care Unit) at the time of data collection
• Not having received breastfeeding education from healthcare professionals

Exclusion Criteria

• The baby dies during the treatment process
• Not participating in the stages of the research
• Asking to withdraw from the study

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bilecik Seyh Edebali Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Rahime Aksoy

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rahime AKSOY BULGURCU

Role: PRINCIPAL_INVESTIGATOR

Bilecik Seyh Edebali Universitesi

Locations

Rahime AKSOY BULGURCU

Bilecik, Gülümbe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBU-AKSOYGUVENC1

Identifier Type: -

Identifier Source: org_study_id