The Effect of Modified Pillow on Safety During Breastfeeding

Taipei Medical University

Status: Completed

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

Treatments: Device: Safe breastfeeding pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT05687383

N202210042

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Normal spontaneous delivered mothers without serious postpartum complications.
2. Normal newborns who can breastfeed.
3. The mother is willing to breastfeed at least 3 times in the cradle position during the hospital stay.
4. Mothers can communicate in Chinese and Taiwanese.
5. Agree to participate in the study and complete the informed consent form.

Exclusion criteria

1. Infants who cannot continue breastfeeding due to condition changes after birth.
2. Mothers who cannot continue breastfeeding due to medical reasons after childbirth.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups, including a placebo group

Safe breastfeeding pillow

Experimental group

Description:

Safe breastfeeding pillow increase the comfort and safety of postpartum women during breastfeeding, thereby prolonging breastfeeding and ensuring optimal nutrition for the baby

Treatment:

Device: Safe breastfeeding pillow

Breastfeeding pillow

Placebo Comparator group

Description:

Providing a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies

Treatment:

Device: Safe breastfeeding pillow