Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-25 @ 3:04 AM
Ignite Modification Date: 2025-12-25 @ 3:04 AM
NCT ID: NCT06250933
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.
Study: NCT06250933
Study Brief:
Protocol Section: NCT06250933