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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250933
• Other study ID #: SBU-AKSOYGUVENC1
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: June 26, 2024

Study information

• Verified date: February 2024
• Source: Bilecik Seyh Edebali Universitesi
• Contact: Rahime AKSOY BULGURCU
• Phone: 05333370688
• Email: rahime.aksoy[@]bilecik.edu.tr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 26, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

• Refusing to participate in the study
• Having communication barriers
• Having a psychiatric diagnosis
• Discharge of the baby during the educational phase

Related Conditions & MeSH terms

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

Intervention

Other:
• Postpartum Maternal Care and Premature Infant Care Training
Intervention groups of women will receive a single-session intervention program in addition to their routine care. The intervention, conducted in a single session, encompasses the provision of an educational program designed to enhance women's breastfeeding and maternal self-efficacy and mitigate the risk of postpartum depression. During the educational phase, women will receive training on postpartum maternal care and premature infant care

Locations

Country	Name	City	State
Turkey	Rahime AKSOY BULGURCU	Bilecik	Gülümbe

Sponsors (1)

Lead Sponsor	Collaborator
Bilecik Seyh Edebali Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postpartum Depression	The Edinburgh Postnatal Depression Scale (EPDS), developed by Cox et al. (1987), is a screening tool designed to assess the risk of depression in women during the postnatal period. It is not intended for the diagnosis of depression. The EPDS is a self-report scale consisting of 10 items, rated on a 4-point Likert scale. Responses with four options are scored between 0 and 3, with the lowest possible score being 0 and the highest 30. In the assessment, items 1, 2, and 4 are scored as 0, 1, 2, 3, while items 3, 5, 6, 7, 8, 9, and 10 are scored in reverse as 3, 2, 1, 0.The cutoff point for the EPDS was calculated as 13, and women with scores of 13 or higher were considered at risk.	On the 42nd day postpartum
Other	Maternal Self-Efficacy	The Perceived Maternal Self-Efficacy Scale This scale was developed by Barnes and Adamson-Macedo (2007) and its Turkish validity and reliability were examined by Kadiroglu (2018). The scale assesses the perceived maternal self-efficacy levels of mothers with prematurely born infants hospitalized in a neonatal intensive care unit. The reliability coefficient for mothers of prematurely born infants in the hospital is 0.98. The scale, consisting of 19 items, is rated on a 1 to 4 scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores obtained are summed to calculate the scale score, ranging from 19 to 76. A higher score indicates a higher perceived maternal self-efficacy level.	On the 42nd day postpartum
Other	Breastfeeding Self-Efficacy	Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants Developed by Wheeler & Dennis (2013), this scale is based on the 14-item 'Breastfeeding Self-Efficacy Scale-Short Form' developed by Dennis (2003) and has undergone Turkish reliability and validity testing by Alus Tokat et al. (2020). Four additional items related to the breastfeeding of hospitalized and/or preterm infants were included. The resulting modified scale comprises 18 items. The scale, utilized among English-speaking Canadian mothers with hospitalized or premature infants, demonstrated a Cronbach's alpha internal consistency of 0.88 (Wheeler and Dennis, 2013). The scale is a 5-point Likert Type scale, where 1= "Not at all confident" and 5= "Always confident." All items are positively phrased. The minimum and maximum scores that can be obtained from the scale are 18 and 90, respectively. A higher score indicates a higher level of breastfeeding self-efficacy.	On the 42nd day postpartum
Primary	Postpartum Depression	The Edinburgh Postnatal Depression Scale (EPDS), developed by Cox et al. (1987), is a screening tool designed to assess the risk of depression in women during the postnatal period. It is not intended for the diagnosis of depression. The EPDS is a self-report scale consisting of 10 items, rated on a 4-point Likert scale. Responses with four options are scored between 0 and 3, with the lowest possible score being 0 and the highest 30. In the assessment, items 1, 2, and 4 are scored as 0, 1, 2, 3, while items 3, 5, 6, 7, 8, 9, and 10 are scored in reverse as 3, 2, 1, 0.The cutoff point for the EPDS was calculated as 13, and women with scores of 13 or higher were considered at risk.	The first week postpartum
Primary	Maternal Self-Efficacy	The Perceived Maternal Self-Efficacy Scale This scale was developed by Barnes and Adamson-Macedo (2007) and its Turkish validity and reliability were examined by Kadiroglu (2018). The scale assesses the perceived maternal self-efficacy levels of mothers with prematurely born infants hospitalized in a neonatal intensive care unit. The reliability coefficient for mothers of prematurely born infants in the hospital is 0.98. The scale, consisting of 19 items, is rated on a 1 to 4 scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores obtained are summed to calculate the scale score, ranging from 19 to 76. A higher score indicates a higher perceived maternal self-efficacy level.	The first week postpartum
Primary	Breastfeeding Self-Efficacy	Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants Developed by Wheeler & Dennis (2013), this scale is based on the 14-item 'Breastfeeding Self-Efficacy Scale-Short Form' developed by Dennis (2003) and has undergone Turkish reliability and validity testing by Alus Tokat et al. (2020). Four additional items related to the breastfeeding of hospitalized and/or preterm infants were included. The resulting modified scale comprises 18 items. The scale, utilized among English-speaking Canadian mothers with hospitalized or premature infants, demonstrated a Cronbach's alpha internal consistency of 0.88 (Wheeler and Dennis, 2013). The scale is a 5-point Likert Type scale, where 1= "Not at all confident" and 5= "Always confident." All items are positively phrased. The minimum and maximum scores that can be obtained from the scale are 18 and 90, respectively. A higher score indicates a higher level of breastfeeding self-efficacy.	The first week postpartum
Secondary	Postpartum Depression	The Edinburgh Postnatal Depression Scale (EPDS), developed by Cox et al. (1987), is a	Two weeks postpartum
Secondary	Maternal Self-Efficacy	The Perceived Maternal Self-Efficacy Scale This scale was developed by Barnes and Adamson-Macedo (2007) and its Turkish validity and reliability were examined by Kadiroglu (2018). The scale assesses the perceived maternal self-efficacy levels of mothers with prematurely born infants hospitalized in a neonatal intensive care unit. The reliability coefficient for mothers of prematurely born infants in the hospital is 0.98. The scale, consisting of 19 items, is rated on a 1 to 4 scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores obtained are summed to calculate the scale score, ranging from 19 to 76. A higher score indicates a higher perceived maternal self-efficacy level.	Two weeks postpartum
Secondary	Breastfeeding Self-Efficacy	Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants Developed by Wheeler & Dennis (2013), this scale is based on the 14-item 'Breastfeeding Self-Efficacy Scale-Short Form' developed by Dennis (2003) and has undergone Turkish reliability and validity testing by Alus Tokat et al. (2020). Four additional items related to the breastfeeding of hospitalized and/or preterm infants were included. The resulting modified scale comprises 18 items. The scale, utilized among English-speaking Canadian mothers with hospitalized or premature infants, demonstrated a Cronbach's alpha internal consistency of 0.88 (Wheeler and Dennis, 2013). The scale is a 5-point Likert Type scale, where 1= "Not at all confident" and 5= "Always confident." All items are positively phrased. The minimum and maximum scores that can be obtained from the scale are 18 and 90, respectively. A higher score indicates a higher level of breastfeeding self-efficacy.	Two weeks postpartum