- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250933
The Meleis Theory on Postpartum Depression, Breastfeeding, and Maternal Self-Efficacy in Women Experiencing Preterm Birth
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rahime AKSOY BULGURCU
- Phone Number: 05333370688
- Email: rahime.aksoy@bilecik.edu.tr
Study Contact Backup
- Name: Gülten GÜVENÇ
- Phone Number: 05366700321
- Email: gulten.guvenc@sbu.edu.tr
Study Locations
-
-
Gülümbe
-
Bilecik, Gülümbe, Turkey, 11230
- Recruiting
- Rahime AKSOY BULGURCU
-
Contact:
- Rahime AKSOY BULGURCU
- Email: rahime.aksoy@bilecik.edu.tr
-
Principal Investigator:
- Gülten GÜVENÇ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experiment group
The experimental group will receive education on postpartum maternal care and premature infant care, in addition to routine care provided by healthcare professionals, based on nursing care grounded in Meleis' Transition Theory.
|
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 |
No Intervention: Control group
The control group will continue to receive routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postpartum Depression
Time Frame: The first week postpartum
|
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
|
Maternal Self-Efficacy
Time Frame: The first week postpartum
|
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 Kadiroğlu (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
|
Breastfeeding Self-Efficacy
Time Frame: The first week postpartum
|
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 Aluş 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postpartum Depression
Time Frame: Two weeks postpartum
|
The Edinburgh Postnatal Depression Scale (EPDS), developed by Cox et al. (1987), is a
|
Two weeks postpartum
|
Maternal Self-Efficacy
Time Frame: Two weeks postpartum
|
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 Kadiroğlu (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
|
Breastfeeding Self-Efficacy
Time Frame: Two weeks postpartum
|
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 Aluş 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postpartum Depression
Time Frame: On the 42nd day postpartum
|
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
|
Maternal Self-Efficacy
Time Frame: On the 42nd day postpartum
|
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 Kadiroğlu (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
|
Breastfeeding Self-Efficacy
Time Frame: On the 42nd day postpartum
|
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 Aluş 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rahime AKSOY BULGURCU, Bilecik Seyh Edebali Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU-AKSOYGUVENC1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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