Effects of Prenatal Preparation Education on First-time Parents
NCT ID: NCT03863444
Last Updated: 2019-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
320 participants
INTERVENTIONAL
2019-02-25
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose: The purpose of this study is to explore whether different prenatal education courses increase the ability of prospective parents to breastfeed, infant care, and support, thereby improving the preparation and quality of life in the early postpartum period, reducing the incidence of postpartum depression, promoting the parenting of newborns, and Attachment Study design: This study adopts a class of experimental design, the study recruited pregnant women 35 to 39 weeks of primipara and their spouses, the study subjects were divided into experimental group and control group, calculated by G\*Power software, alpha is set as 0.05 while power as 0.8. It should be 51 pair of parents in two groups in the third time point. Considering the possible attrition, the investigators will recruit 80 pairs of the experimental group and the control group, respectively. Data collection was conducted on the structured questionnaire on the prenatal, early postpartum, and one month postpartum to explore the effectiveness of different prenatal education courses for primiparas and their partners.
Expected outcome: The prenatal education is expected to elevate the partners' ability of baby care and support to mothers in early postpartum, to decrease postpartum blue, and to promote the attachment between parents and newborns. The results of the questionnaire will be analyzed using descriptive statistics and inferential statistical analysis using the suite software SPSS 15.0 for Windows.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nursing Education Intervention for Maternal Breastfeeding
NCT02106026
Breastfeeding Practice Evaluation in Taiwan
NCT01123733
Antenatal Educational Intervention for Improvement of Breastfeeding
NCT00270192
Integrative Early Breastfeeding Support in NICU
NCT05301309
Applying Interactive E-books on Breastfeeding to Enhance Nursing Students' Learning
NCT07071285
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Before conducting this study, the institutional review board (IRB) has approved this study. The research staffs will approach potential participants during their prenatal visits and invite them to participate in the study. Potential participants would be informed of the study purposes, interventions (routine care for control group, routine care plus intervention for intervention group), and interview contents. After written consent is obtained, the interventions will be arranged. In order to control the quality of data collection, the investigators will train the research assistants. Research training will include ethical concerns about collection of research data, methods of approaching eligible subjects, interviewing techniques, and pilot testing of data collection. The training will provide research assistants by the PI and Co-PI of this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
Routine Care
Routine care
Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.
Intervention Group
Routine Care + Prenatal Preparation Education
Prenatal Preparation Education
Intervention, provided by researchers, includes video, counseling, and skill practices. Video contains (1) Newborn Reaction, including rooting reflex, correct latch-on posture, assuring newborn having enough milk intakes; (2) Newborn Care, including holding, dipper-changing, clothes-changing, and swaddle the newborn; and (3) Partner Support, including the importance of partner support and the content how partner provide support to the postpartum women. After watching the video, the researcher will provide participants counseling, and then each pair of participants will have skill practice.
Routine care
Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prenatal Preparation Education
Intervention, provided by researchers, includes video, counseling, and skill practices. Video contains (1) Newborn Reaction, including rooting reflex, correct latch-on posture, assuring newborn having enough milk intakes; (2) Newborn Care, including holding, dipper-changing, clothes-changing, and swaddle the newborn; and (3) Partner Support, including the importance of partner support and the content how partner provide support to the postpartum women. After watching the video, the researcher will provide participants counseling, and then each pair of participants will have skill practice.
Routine care
Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (2) adults
* (3) primipara and their spouses
* (4) having routine prenatal visits and plan to have the birth in the medical center
* (5) able to communicate with Mandarin or Taiwanese
* (6) willing to participate in this study and give written inform-consent forms
Exclusion Criteria
* (2) high-risk pregnancy
* (3) cannot room-in due to newborn's medical conditions
20 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Taiwan University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
I-Yuan Yen, MS
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
Dennis CL, Brown HK, Brennenstuhl S. The Postpartum Partner Support Scale: Development, psychometric assessment, and predictive validity in a Canadian prospective cohort. Midwifery. 2017 Nov;54:18-24. doi: 10.1016/j.midw.2017.07.018. Epub 2017 Jul 29.
Ho YJ, McGrath JM. A Chinese version of Iowa Infant Feeding Attitude Scale: reliability and validity assessment. Int J Nurs Stud. 2011 Apr;48(4):475-8. doi: 10.1016/j.ijnurstu.2010.09.001. Epub 2010 Oct 18.
Hung CH, Stocker J, Hsu HT. Comparing Taiwanese women's biopsychosocial features by location of postpartum recovery. Appl Nurs Res. 2014 May;27(2):121-6. doi: 10.1016/j.apnr.2013.11.010. Epub 2013 Nov 11.
Lai, Y.-I. (2009). Under the policy of mother-baby friendly, postpartum women's fatigue, baby-care activities and maternal-infant attachment with different types of delivery (Unpublished master's thesis) [Traditional Chinese]. College of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.
Lee, K.-L, Ou, Y.-L., Chen, S.-H., & Weng, L.-J. (2009). The psychometric properties of a short form of the CES-D used in the Taiwan longitudinal study on aging [Traditional Chinese]. Formosa Journal of Mental Health, 22(4), 383-410. doi: 10.30074/cjmh.200912.0002
Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201810089RINA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.