Effects of Prenatal Preparation Education on First-time Parents

NCT03863444 | Unknown

• 1 other identifier: 201810089RINA
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parenting; Partner, Domestic

Keywords

First-time Parents; Prenatal Preparation Education; Partner Support

Outcome Measures

Primary Outcomes (5)

• 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).

• 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).

• 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).

• 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).

• 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 Outcomes (3)

• Social Support Scale (SSS)

  Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).

• Center for Epidemiologic Studies Depression Scale (CES-D) - Short Form

  Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).

• Background and Obstetric/Breastfeeding Information Form (BOBIF)

  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).

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Routine Care

Other: Routine care

Intervention Group

EXPERIMENTAL

Routine Care + Prenatal Preparation Education

Other: Prenatal Preparation Education; Other: Routine care

Interventions

Prenatal Preparation Education OTHER

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.

Intervention Group

Routine care OTHER

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (1) having fetus with abnormality
• (2) high-risk pregnancy
• (3) cannot room-in due to newborn's medical conditions

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (7)

• 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.

  PMID: 14649593 BACKGROUND

• 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.

  PMID: 28780475 BACKGROUND

• 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.

  PMID: 20961544 BACKGROUND

• 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.

  PMID: 24360779 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.

  PMID: 7780768 BACKGROUND

Study Officials

• I-Yuan Yen, MS

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Yuan Yen, MS

CONTACT

+886-2-23123456; iyuanyen@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be divided into the experimental group and control group. In order to avoid the contamination between the control group and the experimental group due to the simultaneous empty space and information sharing, the control group will be recruited in the study in the first two months. After control group recruitment, we will recruit the intervention group and provide prenatal education.

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 5, 2019
• Study Start: February 25, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share