Effects of Prenatal Preparation Education on First-time Parents

Parenting Clinical Trial

Official title:

I-Yuan Yen, Registered Nurse Department of Nursing, National Taiwan University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03863444
• Other study ID #: 201810089RINA
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: National Taiwan University Hospital
• Contact: I-Yuan Yen, MS
• Phone: +886-2-23123456
• Email: iyuanyen[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• (1) gestational age 35 to 39 weeks

• (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:

• (1) having fetus with abnormality

• (2) high-risk pregnancy

• (3) cannot room-in due to newborn's medical conditions

Related Conditions & MeSH terms

• Parenting
• Partner, Domestic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Müller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Iowa Infant Feeding Attitude Scale (IIFAS)	The Iowa Infant Feeding Attitude Scale (IIFAS) measured the parents' attitude toward infant feeding with 17 Likert's scale items (Ho & McGrath, 2011). Each item scored from 1 to 5 (1 = strongly disagree, 5 = strongly agree). Items 1, 2, 4, 6, 8, 10, 11, 14, and 17 will be reversed code. The higher score indicated the higher intention to choose breastfeeding; lower scores indicated the intention to choose formula feeding. Cronbach's alpha is 0.75.	Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Primary	Changes of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)	The Breastfeeding Self-Efficacy Scale-Short Form measured the breastfeeding self-efficacy with 14 Likert's scale items (Dennis, 2003). Each item scored from 1 to 5 (1 = not at all confident, 5 = always confident). The total scores range from 14 to 70. The higher score indicates the higher levels of breastfeeding self-efficacy.	Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Primary	Changes of Postpartum Partner Support Scale (PPSS)	The Postpartum Partner Support Scale (PPSS) measured the prenatal/postpartum partner support perceived by postpartum women and reported by the partners with 20 Likert's scale items (Dennis, Brown, & Brennenstuhl, 2017). Each item scored from 1 to 4 (1 = strongly disagree, 4 = strongly agree). One item will be reverse-coded. The total score ranges from 20 to 80. The higher score indicated the higher postpartum partner support perceived by postpartum women or the partners. For T1, the description of measure item has been mild-modified to better reflect the prenatal status.	Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Primary	Changes of Maternal Attachment Inventory (MAI)	The Maternal Attachment Inventory (MAI) measured the maternal/paternal-infant attachment with 26 items (Lai, 2009; Muller, 1994). Each item scored from 1 to 4 (1 = rarely, 4 = almost). The higher score indicated the better attachment between the mother and the infant. Cronbach's alpha is 0.97.	Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
Primary	Changes of Difficulty in Baby-Care Activities Scale (DIBCAS)	The Difficulty in Baby-Care Activities Scale (DIBCAS) measured the difficulties that parents faced in the baby-care activities (Lai, 2009). The 14 items included four aspects: infant feeding, clean & comfort, safe & healthy, and smoothing behaviors. Each item scored from 1 to 4 (1 = no difficulty at all; 2 = a little bit difficult, 3 = difficult, 3 = totally difficult). The higher score indicated the higher difficulty level the parents faced in baby-care activities. The Cronbach's alpha of the total scale is 0.91	Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
Secondary	Social Support Scale (SSS)	The Social Support Scale (SSS) measured the social support perceived by the parents from their families and friends with 10 Likert's scale items (Hung, Stocker, & Hsu, 2014). Social support is one of the control variables in this study. Each item scored from 1 to 5 (1 = never and 5 = always). The total score ranges from 10 to 50. The higher score indicated the better social support from families and friends. Cronbach's alpha is 0.92 for the whole scale and are 0.70-0.81 for subscales. Item-to-total correlations are 0.38-0.69. Factor analysis showed the two-factor structure, supporting the construction validity.	Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D) - Short Form	The Short Form of the Center for Epidemiologic Studies Depression Scale (CES-D-SF) measured severity of depressive symptom during the past week with 10 items (Lee, Ou, Chen, & Weng, 2009). Each item scored from 0 to 3 (0 = Rarely or none of the time [less than one day]; 1 = Some or a little of the time [1-2 days]; 2 = Occasionally or a moderate amount of time [3-4 days]; 3 = Most or all of the time [5-7 days]). Positive items will be reverse-coded. The total score ranges from 0 to 30. The higher score indicated the more severe depressive symptoms. Cronbach's alpha is 0.86.	Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Secondary	Background and Obstetric/Breastfeeding Information Form (BOBIF)	In addition background data of the new parents (age, education, marriage status, whether this pregnancy was planned, employment, family income), obstetric and breastfeeding information, including childbirth type, gestation week in birth, immediately skin-to-skin tough after birth, rooming-in type, feeding type, will also collected from medical records by research staffs.	Background information of parents will be assessed at Gestational Week 35~39 (T1). Obstetric and breastfeeding information will be assessed at postpartum 3~5 days (T2).