BreastfeedingNCT05687383
The Effect of Modified Pillow on Safety During Breastfeeding
A study testing Safe breastfeeding pillow in people with Breastfeeding and Pregnancy Related, run by Taipei Medical University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Pregnancy Related, Newborn; Fit
- What is being tested?
- Safe breastfeeding pillow
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Infants who cannot continue breastfeeding due to condition changes after birth.
- Mothers who cannot continue breastfeeding due to medical reasons after childbirth.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Breastfeeding, Pregnancy Related, Newborn; Fit, Safety Issues
- Being tested
- Safe breastfeeding pillow
- Keywords
- Breastfeeding, Pillow, Safety issues, Comfort, Newborn, Pregnancy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe breastfeeding pillowDevice
Also called Breastfeeding pillow
A randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| Safe breastfeeding pillow | Experimental | Safe breastfeeding pillow increase the comfort and safety of postpartum women during breastfeeding, thereby prolonging breastfeeding and ensuring optimal nutrition for the baby Receives: Device: Safe breastfeeding pillow |
| Breastfeeding pillow | Placebo comparator | Providing a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies Receives: Device: Safe breastfeeding pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy Scale (BSES)
A 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence
Measured: through study completion, an average of 2-7 days
Secondary outcomes (3)
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."
Measured: through study completion, an average of 2-7 days
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".
Measured: through study completion, an average of 2-7 days
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
Measured: through study completion, an average of 2-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start11 Apr 2023
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687383
- Sponsor's protocol ID
- N202210042
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chou JF, Kuo CH, Tam KW, Jen HJ, Chang WP, Chou YY, Chen KH. Effects of Traditional and Innovative Safe Breastfeeding Pillows on Postpartum Maternal Breastfeeding Self-Efficacy, Awareness, and Comfort: A Randomized Controlled Trial. J Nurs Manag. 2026;2026(1):e8414086. doi: 10.1155/jonm/8414086.
PubMed 42299080
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Pillow on Safety During Breastfeeding
- ClinicalTrials.gov ID
- NCT05687383
- Acronym / sponsor ID
- N202210042
- Conditions
- Breastfeeding, Pregnancy Related, Newborn; Fit, Safety Issues
- Keywords
- Breastfeeding, Pillow, Safety issues, Comfort, Newborn, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe breastfeeding pillow | Experimental | Device: Safe breastfeeding pillowSafe breastfeeding pillow increase the comfort and safety of postpartum women during breastfeeding, thereby prolonging breastfeeding and ensuring optimal nutrition for the baby |
| Breastfeeding pillow | Placebo comparator | Device: Safe breastfeeding pillowProviding a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Infants who cannot continue breastfeeding due to condition changes after birth.
- Mothers who cannot continue breastfeeding due to medical reasons after childbirth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe breastfeeding pillowAlso: Breastfeeding pillowA randomized controlled trial | Device | Breastfeeding pillow, Safe breastfeeding pillow |
Primary outcome
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
3 secondary outcomes
Breastfeeding safety scale
Time frame: through study completion, an average of 2-7 days
Body Part Discomfort Scale (BPDS)
Time frame: through study completion, an average of 2-7 days
B-R-E-A-S-T-Feed scale
Time frame: through study completion, an average of 2-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 42299080Chou JF, Kuo CH, Tam KW, Jen HJ, Chang WP, Chou YY, Chen KH. Effects of Traditional and Innovative Safe Breastfeeding Pillows on Postpartum Maternal Breastfeeding Self-Efficacy, Awareness, and Comfort: A Randomized Controlled Trial. J Nurs Manag. 2026;2026(1):e8414086. doi: 10.1155/jonm/8414086.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe breastfeeding pillow in people with Breastfeeding and Pregnancy Related, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy Scale (BSES) (time frame: through study completion, an average of 2-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05687383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.