Clinical trial NCT06250933: The Meleis Theory on Postpartum Depression, Breastfeeding, and Maternal Self-Efficacy in Women Experiencing Preterm Birth
Official title: The Effect of Nursing Approach Grounded in Meleis's Transition Theory on Postpartum Depression, Maternal Self-Efficacy, and Breastfeeding Self-Efficacy in Women Experiencing Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Theory, Double Bind
Postpartum Depression
Breast Feeding
Self Efficacy
Keywords: premature birth
Theory
Postpartum Depression
Breastfeeding
Self efficacy
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following recruitment, the women were divided into a study and a control group by randomization (1:2 randomization)
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postpartum Depression
timeFrame: The first week postpartum
measure: Maternal Self-Efficacy
timeFrame: The first week postpartum
measure: Breastfeeding Self-Efficacy
timeFrame: The first week postpartum
Secondary outcomes:
measure: Postpartum Depression
timeFrame: Two weeks postpartum
measure: Maternal Self-Efficacy
timeFrame: Two weeks postpartum
measure: Breastfeeding Self-Efficacy
timeFrame: Two weeks postpartum
Other outcomes:
measure: Postpartum Depression
timeFrame: On the 42nd day postpartum
measure: Maternal Self-Efficacy
timeFrame: On the 42nd day postpartum
measure: Breastfeeding Self-Efficacy
timeFrame: On the 42nd day postpartum
Locations:
city: Bilecik
country: Turkey
facility: Rahime AKSOY BULGURCU
state: Gülümbe
Study officials:
affiliation: Bilecik Seyh Edebali Universitesi
name: Rahime AKSOY BULGURCU
role: PRINCIPAL_INVESTIGATOR
References: