The Effect of Modified Pillow on Safety During Breastfeeding

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Modified Pillow on Safety During Breastfeeding

Conditions
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Breastfeeding, Pregnancy Related, Newborn; Fit, Safety Issues

Intervention / Treatment
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* Device: Safe breastfeeding pillow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal spontaneous delivered mothers without serious postpartum complications. Normal newborns who can breastfeed. The mother is willing to breastfeed at least 3 times in the cradle position during the hospital stay. Mothers can communicate in Chinese and Taiwanese. Agree to participate in the study and complete the informed consent form. Exclusion Criteria: Infants who cannot continue breastfeeding due to condition changes after birth. Mothers who cannot continue breastfeeding due to medical reasons after childbirth.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safe breastfeeding pillow<br>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<br>* A randomized controlled trial<br>* Other names: Breastfeeding pillow;|
| Placebo Comparator: Breastfeeding pillow<br>Providing a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies | Device: Safe breastfeeding pillow<br>* A randomized controlled trial<br>* Other names: Breastfeeding pillow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Pillow, Safety issues, Comfort, Newborn, Pregnancy