Skip to content

The Effect of Modified Pillow on Safety During Breastfeeding

The Effect of Modified Pillow on Safety During Breastfeeding

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05687383
Enrollment
150
Registered
2023-01-18
Start date
2023-04-11
Completion date
2023-08-30
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Newborn; Fit, Pregnancy Related, Safety Issues

Keywords

Breastfeeding, Pillow, Safety issues, Comfort, Newborn, Pregnancy

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.

Interventions

DEVICESafe breastfeeding pillow

A randomized controlled trial

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding Self-Efficacy Scale (BSES)through study completion, an average of 2-7 daysA 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence

Secondary

MeasureTime frameDescription
Breastfeeding safety scalethrough study completion, an average of 2-7 daysA 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.
Body Part Discomfort Scale (BPDS)through study completion, an average of 2-7 daysUsed 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.
B-R-E-A-S-T-Feed scalethrough study completion, an average of 2-7 daysEvaluate the breastfeeding position and latching position of the parturient. The evaluation items include: Body position, responses, emotional bonding, anatomy, suckling, time spent sucking

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026