The Effect of Modified Pillow on Safety During Breastfeeding

Pregnancy Related Clinical Trial

Official title:

The Effect of Modified Pillow on Safety During Breastfeeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687383
• Other study ID #: N202210042
• Status: Completed
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• Newborn; Fit
• Pregnancy Related
• Safety Issues

Intervention

Device:
• Safe breastfeeding pillow
A randomized controlled trial

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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