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

Premature Birth Clinical Trial

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

Status Recruiting

Clinical Trial Summary

A randomized controlled study will be conducted to evaluate the impact of nursing intervention based on Meleis' Transition Theory on postpartum depression, maternal self-efficacy, and breastfeeding self-efficacy in women who have experienced preterm birth.

The postpartum period represents a transitional and adaptive phase for mothers as they embrace a new role. However, the occurrence of preterm birth and the necessity of neonatal intensive care unit (NICU) care for the newborn can initiate emotional distress in mothers, particularly when facing the admission of their infants to the intensive care setting. Consequently, the transition to new roles for mothers becomes challenging. A healthy transition to the maternal role is crucial for mothers who have experienced preterm birth, positively influencing maternal self-efficacy and breastfeeding practices while reducing the likelihood of postpartum depression. Therefore, the transition to motherhood in women with preterm births is of paramount importance for both the mother and the premature infant, warranting careful consideration and discussion.

Women who have experienced preterm birth will constitute the population of the study. During the research period, women who have experienced preterm birth and whose infants are admitted to the neonatal intensive care unit (NICU) will form the population of the study, and the sample will consist of women who consent to participate in the study during the study period. The sample size was estimated using power analysis (G Power 3.1.9.4.) program with a power of (1-β=0.90) and a significance level of (α=0.05), taking into account the mean and standard deviation of a similar study in the literature (Kadiroğlu and Güdücü Tüfekci 2022) (63.53±8.67 for the experimental group; 56.63±9.73 for the control group). The sample size of the study was calculated to be sufficient with a total of 64 women, with 32 women in each group. Considering potential losses during the study process, and in order not to compromise the statistical power of the research, an additional 20% of women were included in the study, resulting in a total of 76 women to be included in the study. Within the scope of the research, data will be obtained through the 'Personal Data Form' containing information about the socio-demographic characteristics of the participating women, as well as the 'Edinburgh Postnatal Depression Scale,' 'Perceived Maternal Self-Efficacy Scale,' and the 'Breastfeeding Self-Efficacy Scale.

Clinical Trial Description

The implementation will take place at the Maternity Guesthouse and Level 3 Neonatal Intensive Care Unit (NICU) in a hospital in Turkey. Ethical principles will be considered in the research. Following the necessary adjustments in the data collection forms, written and verbal explanations about the study will be provided to the participants, and their informed consent will be obtained. Data collection forms will be individually administered through face-to-face interviews with women volunteering to participate in the research. The data collection process will be carried out in four stages. In the first stage, face-to-face data collection tools will be applied to the control and intervention groups. In the second stage, the intervention group will receive training based on the Meleis Transition Theory nursing approach. In the third stage, data collection forms will be re-administered to the control and intervention groups in the second week postpartum. In the fourth stage, data collection forms will be re-administered to the control and intervention groups on the 42nd day postpartum, followed by providing the control group with an educational booklet based on the Meleis Transition Theory nursing approach. ;

Related Conditions & MeSH terms

• Breast Feeding
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression
• Premature Birth
• Self Efficacy

• NCT number: NCT06250933
• Study type: Interventional
• Source: Bilecik Seyh Edebali Universitesi
• Contact: Rahime AKSOY BULGURCU
• Phone: 05333370688
• Email: rahime.aksoy@bilecik.edu.tr
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Completion date: June 26, 2024