Parenting Clinical Trial
Official title:
I-Yuan Yen, Registered Nurse Department of Nursing, National Taiwan University Hospital
Background: In 2001, the National Health Service of the Ministry of Health and Welfare
promoted breastfeeding by adopting the ten measures of successful breastfeeding. However,
there is still much room for improvement in Taiwan's continued breastfeeding rate. Currently,
although the breastfeeding education is given since pregnancy, the postpartum women were
still suffering from baby's and themselves demands, such as unfamiliar with breastfeeding
skills, fatigue, discomfort. When the baby is crying, I don't know how to comfort, and I need
help from others. The nursing staff cannot provide immediate assistance due to busy clinical
work. It showed that it is very important to include the partners to provide assistance and
support to postpartum women. The prenatal education for partners is the opportunity to
elevate the partners' ability of baby care and support to mothers.
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.
This study adopts a quasi-experimental design. Eligible subjects are pregnant women 35 to 39
weeks of primipara and their spouses. Specifically, inclusion criteria are (1) gestational
age 35 to 39 weeks, (2) adults, (3) primipara and their spouses, (4) having routine prenatal
visits and plan to have birth in the medical center, (5) able to communicate with Mandarin or
Taiwanese, and (6) willing to participate in this study and give written inform-consent
forms. Exclusion criteria are (1) having fetus with abnormality, (2) high-risk pregnancy, and
(3) cannot room-in due to newborn's medical conditions. Participants would be assessed on the
time points of recruitment (T1), early postpartum during hospitalization (T2), and one-month
postpartum (T3).
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.
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