Trials / Completed
CompletedNCT05687383
The Effect of Modified Pillow on Safety During Breastfeeding
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Taipei Medical University · Academic / Other
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Safe breastfeeding pillow | A randomized controlled trial |
Timeline
- Start date
- 2023-04-11
- Primary completion
- 2023-08-30
- Completion
- 2023-08-30
- First posted
- 2023-01-18
- Last updated
- 2023-11-28
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05687383. Inclusion in this directory is not an endorsement.