Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250933
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-08
Brief Title:
The Meleis Theory on Postpartum Depression Breastfeeding and Maternal Self-Efficacy in Women Experiencing Preterm Birth
Sponsor:
Bilecik Seyh Edebali Universitesi
Organization:
Bilecik Seyh Edebali Universitesi
Study Overview
Official Title:
The Effect of Nursing Approach Grounded in Meleiss Transition Theory on Postpartum Depression Maternal Self-Efficacy and Breastfeeding Self-Efficacy in Women Experiencing Preterm Birth
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 3194 program with a power of 1-β090 and a significance level of α005 taking into account the mean and standard deviation of a similar study in the literature Kadiroğlu and Güdücü Tüfekci 2022 6353867 for the experimental group 5663973 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
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 3194 program with a power of 1-β090 and a significance level of α005 taking into account the mean and standard deviation of a similar study in the literature Kadiroğlu and Güdücü Tüfekci 2022 6353867 for the experimental group 5663973 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None