Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the effectiveness of a modified product "safe breastfeeding pillow" in enhancing the comfort and safety of postpartum women during breastfeeding. The results of this study can be used as a reference to promote clinical practice and education on breastfeeding to prolong the duration of breastfeeding and to ensure the safety of newborns.
Breastfeeding has a significant long-term positive impact on the health, nutrition and development of children, as well as the physical and mental health of women. Baby-Friendly Hospital Initiative (BFHI) was launched by the World Health Organization and UNICEF in 1991 to encourage comfortable, supportive, and safe breastfeeding environments (Byrom et al., 2021). During breastfeeding, mothers need to maintain the same position with their hands for long periods of time, which can lead to muscle pain due to improper posture. In addition, postpartum fatigue can also lead to newborn fall accidents (Lipke et al., 2018).
Objective: To investigate the effectiveness of a modified pillow to enhance the comfort and safety of postpartum women during breastfeeding.
METHODS: A randomized controlled trial was conducted. Mothers and infants who gave birth naturally without serious postpartum complications at a university affiliate hospital will recruit in northern Taiwan. A questionnaire containing "Breastfeeding Self-Efficacy Scale (BSES)", "B-R-E-A-S-T-Feed scale", "Breastfeeding safety scale", and "Body Part Discomfort Scale (BPDS)" will be used to assess comfort and safety during breastfeeding.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safe breastfeeding pillow | Experimental | Safe breastfeeding pillow increase the comfort and safety of postpartum women during breastfeeding, thereby prolonging breastfeeding and ensuring optimal nutrition for the baby |
|
| Breastfeeding pillow | Placebo Comparator | Providing a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe breastfeeding pillow | Device | A randomized controlled trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding Self-Efficacy Scale (BSES) | A 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence | through study completion, an average of 2-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding safety scale | A total of four questions using "The Likert scale" to evaluate the mother's level of safety during breastfeeding using a 4-point, with 1 point indicating "very worrying" and 4 points representing "very secure." | through study completion, an average of 2-7 days |
| Body Part Discomfort Scale (BPDS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | 11031 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42299080 | Derived | Chou JF, Kuo CH, Tam KW, Jen HJ, Chang WP, Chou YY, Chen KH. Effects of Traditional and Innovative Safe Breastfeeding Pillows on Postpartum Maternal Breastfeeding Self-Efficacy, Awareness, and Comfort: A Randomized Controlled Trial. J Nurs Manag. 2026;2026(1):e8414086. doi: 10.1155/jonm/8414086. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Used to evaluate the comfort level of body parts during breastfeeding of parturients. There are 10 items in total, and the 4-point Likert scale is used for scoring, with 1 point representing "very uncomfortable" and 4 points representing "very comfortable". |
| through study completion, an average of 2-7 days |
| B-R-E-A-S-T-Feed scale | Evaluate the breastfeeding position and latching position of the parturient. The evaluation items include: Body position, responses, emotional bonding, anatomy, suckling, time spent sucking | through study completion, an average of 2-7 days |