An interventional study of Safe breastfeeding pillow in Breastfeeding, Pregnancy Related and Newborn; Fit, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care
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.
Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Safe breastfeeding pillow increase the comfort and safety of postpartum women during breastfeeding, thereby prolonging breastfeeding and ensuring optimal nutrition for the baby
Device: Safe breastfeeding pillow
Providing a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies
Device: Safe breastfeeding pillow
A randomized controlled trial
Also known as: Breastfeeding pillow
Breastfeeding Self-Efficacy Scale (BSES)
A 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence
Time frame: through study completion, an average of 2-7 days
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."
Time frame: through study completion, an average of 2-7 days
Body Part Discomfort Scale (BPDS)
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".
Time frame: 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
Time frame: through study completion, an average of 2-7 days
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Taipei Medical University