Premature BirthNCT06250933
The Meleis Theory on Postpartum Depression, Breastfeeding, and Maternal Self-Efficacy in Women Experiencing Preterm Birth
A study testing Postpartum Maternal Care and Premature Infant Care Training in people with Premature Birth and Theory, Double Bind, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Theory, Double Bind, Postpartum Depression
- What is being tested?
- Postpartum Maternal Care and Premature Infant Care Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The baby dies during the treatment process
- Not participating in the stages of the research
- Asking to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Premature Birth, Theory, Double Bind, Postpartum Depression, Breast Feeding, Self Efficacy
- Being tested
- Postpartum Maternal Care and Premature Infant Care Training
- Keywords
- premature birth, Theory, Postpartum Depression, Breastfeeding, Self efficacy
- Medical subject headings
- Premature Birth, Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Maternal Care and Premature Infant Care TrainingOther
Training and counseling were provided. In this context, training consisting of three sessions of 100 minutes in total was provided and counseling was provided in the following weeks by conducting 3-4 telephone interviews.
The intervention involves the provision of a training and counseling program designed to increase women's breastfeeding and maternal self-efficacy and reduce the risk of postpartum depression.
In the training phase, women will receive training on postpartum maternal care and premature infant care.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | In the intervention group, training and counseling were provided within the scope of the nursing approach based on Meleis transition theory. In this context, training consisting of three sessions of 100 minutes in total was given and counseling was provided by conducting 3-4 interviews by phone in the following weeks. 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. In this process, the women were evaluated three times in total, in the first postpartum week (pre-test), two weeks after delivery (post-test 1) and 42nd day (6th week) (post-test 2) with the Breastfeeding Self-Efficacy Scale, Perceived Maternal Self-Efficacy Scale and Edinburgh Postpartum Depression Scale.
Translated with DeepL.com (free version) Receives: Other: Postpartum Maternal Care and Premature Infant Care Training |
| Control group | No intervention | The control group will continue to receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first week postpartum
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 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.
Measured: The first week postpartum
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 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.
Measured: The first week postpartum
Secondary outcomes (3)
Postpartum Depression
The Edinburgh Postnatal Depression Scale (EPDS), developed by Cox et al. (1987), is a
Measured: Two weeks postpartum
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 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.
Measured: Two weeks postpartum
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 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.
Measured: Two weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Jan 2024
- Primary completion27 Mar 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following recruitment, the women were divided into a study and a control group by randomization (1:2 randomization)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Aksoy, Bilecik Seyh Edebali Universitesi
- Investigators
- Rahime AKSOY BULGURCU, Principal investigator, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250933
- Sponsor's protocol ID
- SBU-AKSOYGUVENC1
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06250933
- Acronym / sponsor ID
- SBU-AKSOYGUVENC1
- Conditions
- Premature Birth, Theory, Double Bind, Postpartum Depression, Breast Feeding, Self Efficacy
- Keywords
- premature birth, Theory, Postpartum Depression, Breastfeeding, Self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Following recruitment, the women were divided into a study and a control group by randomization (1:2 randomization)
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Other: Postpartum Maternal Care and Premature Infant Care TrainingIn the intervention group, training and counseling were provided within the scope of the nursing approach based on Meleis transition theory. In this context, training consisting of three sessions of 100 minutes in total was given and counseling was provided by conducting 3-4 interviews by phone in the following weeks. 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. In this process, the women were evaluated three times in total, in the first postpartum week (pre-test), two weeks after delivery (post-test 1) and 42nd day (6th week) (post-test 2) with the Breastfeeding Self-Efficacy Scale, Perceived Maternal Self-Efficacy Scale and Edinburgh Postpartum Depression Scale. Translated with DeepL.com (free version) |
| Control group | No intervention | –The control group will continue to receive routine care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to participate in the study
- Without communication barriers
- Literate
- Married
- Not undergoing psychological treatment
Key exclusion criteria (3 listed)
- The baby dies during the treatment process
- Not participating in the stages of the research
- Asking to withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum Maternal Care and Premature Infant Care TrainingTraining and counseling were provided. In this context, training consisting of three sessions of 100 minutes in total was provided and counseling was provided in the following weeks by conducting 3-4 telephone interviews. The intervention involves the provision of a training and counseling program designed to increase women's breastfeeding and maternal self-efficacy and reduce the risk of postpartum depression. In the training phase, women will receive training on postpartum maternal care and premature infant care. | Other | Experiment group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Postpartum Depression
Time frame: Two weeks postpartum
Maternal Self-Efficacy
Time frame: Two weeks postpartum
Breastfeeding Self-Efficacy
Time frame: Two weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahime AKSOY BULGURCU principal investigator
Bilecik Seyh Edebali Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Maternal Care and Premature Infant Care Training in people with Premature Birth and Theory, Double Bind, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression (time frame: The first week postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.