Clinical trial NCT05687383: The Effect of Modified Pillow on Safety During Breastfeeding
Official title: The Effect of Modified Pillow on Safety During Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Pregnancy Related
Newborn; Fit
Safety Issues
Keywords: Breastfeeding
Pillow
Safety issues
Comfort
Newborn
Pregnancy
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breastfeeding Self-Efficacy Scale (BSES)
timeFrame: through study completion, an average of 2-7 days
Secondary outcomes:
measure: Breastfeeding safety scale
timeFrame: through study completion, an average of 2-7 days
measure: Body Part Discomfort Scale (BPDS)
timeFrame: through study completion, an average of 2-7 days
measure: B-R-E-A-S-T-Feed scale
timeFrame: through study completion, an average of 2-7 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: