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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05064982
Other study ID # 09.2021.845
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2021
Est. completion date October 2023

Study information

Verified date September 2021
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Paternal involvement in breastfeeding has been identified as a significant predictor in maternal breastfeeding outcomes. The main aim of this study is to examine the relationship between reported paternal breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration. The hypothesis is that paternal involvement in breastfeeding increase exclusive breastfeeding rates, total breastfeeding duration and strengthen paternal-infant attachment.


Description:

Initiation, duration and exclusivity of breastfeeding are greatly influenced by paternal involvement in breastfeeding. Previous studies showed that fathers who are involved in the breastfeeding process have stronger attachments with their babies. However, research on fathers' involvement in their partners' breastfeeding is lacking and there are no comprehensive studies conducted on the effects of the paternal involvement and infant attachment on exclusive breastfeeding (EB) and total breastfeeding duration. Therefore, the aim of the study is to examine the relationship between fathers reported breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration. Data will be collected from a tertiary university hospital. The study will be conducted in two phases. In the first phase, the researcher will approach healthy, term, one month old babies and their fathers who fulfilled the eligibility criteria and will invite them to participate in the study. Informed consent will be obtained from participating fathers. The Partner Breastfeeding Influence scale will be used to measure fathers' involvement in their partner's breastfeeding, Paternal-infant attachment, paternal depression, and marital adjustment will be measured with Paternal-Infant Attachment Questionnaire, Edinburgh Postpartum Depression Scale and Marital Adjustment Scale respectively. Four sets of questionnaires will be administered at two time points for the study. The first set will be administered at postpartum first month. The second set of data will be collected at postpartum six months. In the second phase, fathers participating in the study will be interviewed for breastfeeding duration and factors associated with cessation will be explored at postpartum 12 and 24 months.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 230
Est. completion date October 2023
Est. primary completion date October 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: Fathers of - one-month-old, - healthy, - breastfed infants Exclusion Criteria: - Infants with a birth weight less than 2500 grams - Infants who are less than 37 weeks gestation - Infants with prenatally suspected or diagnosed congenital defects - Parents with major depression - Divorced or separated couples

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Marmara University School of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding duration Exclusive breastfeeding duration will be asked with a single question at six months at 6 months
Primary Total breastfeeding duration Total breastfeeding duration will be asked with a single question at 12 months at 12 months
Primary Total breastfeeding duration Total breastfeeding duration will be asked with a single question at 12 months at 24 months
Secondary Change in perceived paternal breastfeeding support The Partner Breastfeeding Influence Scale (PBIS) will be used to measure perceived breastfeeding support and will be assessed using five dimensions of partner breastfeeding support. These are Savvy, helping, appreciation, breastfeeding presence, and responsiveness. Mean scores are calculated from all questions, from 1 (extremely not supportive) to 5 (extremely supportive) for each breastfeeding support component. High scores show that breastfeeding support of father is notable. Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Secondary Change in Paternal-Infant Attachment The Paternal-Infant Attachment Scale (PIAS) will be used to measure the strength of the bond between the father and infant. The PIAS is a scale consisting of 19 items, with every item graded between 1 and 5 points. High scores show that the attachment is strong. The gathered score average from PIAS is near the score of 19 (minimum value) show a weak attachment; however, when it is near the score of 95 (the maximum value), show a strong attachment. Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Secondary Change in paternal depression The Edinburgh Postpartum Depression Scale (EPDS) will be used to detect depression as a screening tool. The EPDS is a ten item self-report questionnaire. Items 1 and 2 assess anhedonia; item 3: self-blame; item 4: anxiety; item 5: fear or panic; item 6: inability to cope; item 7: difficulty sleeping; item 8: sadness; item 9: tearfulness and item 10: self-harm ideas. Responses are scored as 0, 1, 2 and 3 according to the increasing severity of the symptoms. Total score is calculated by adding each score of each 10 items. The value of score can range from 0 to 30. The traditional cut-off score for the Edinburgh Postpartum Depression Scale when assessing women is 13 or greater however, a lower cut-off score is recommended for fathers as men express emotions differently from women, mainly that they are less expressive with their negative emotions. For this study a cut-off score of 10 or above will be used to assess Paternal Postpartum Depression. Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Secondary Change in Marital Adjustment The Marital Adjustment Scale (MAS) consists of 15 items that evaluate general adjustment, conflict resolution, attachment, and communication. High scores from this scale indicates high marital adjustment. The value of score can range 0 to 60. A score of less than a 43 or below reflects marital distress in marital adjustment scale. Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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