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Completed

NCT Number: NCT05687383

The Effect of Modified Pillow on Safety During Breastfeeding

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Newborn; Fit Pregnancy Related Safety Issues

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Safe breastfeeding pillow

Device

A randomized controlled trial

Other names: Breastfeeding pillow

Primary outcomes

  1. Breastfeeding Self-Efficacy Scale (BSES)

    Time frame: through study completion, an average of 2-7 days

    A 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence

Secondary outcomes

  1. Breastfeeding safety scale

    Time frame: through study completion, an average of 2-7 days

    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."

  2. Body Part Discomfort Scale (BPDS)

    Time frame: through study completion, an average of 2-7 days

    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".

  3. B-R-E-A-S-T-Feed scale

    Time frame: through study completion, an average of 2-7 days

    Evaluate the breastfeeding position and latching position of the parturient. The evaluation items include: Body position, responses, emotional bonding, anatomy, suckling, time spent sucking

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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