Parent Infant Skin-to-Skin Contact Intervention Based on The Co-parenting Theory

NCT05785806 | Completed

• 1 other identifier: JNU20221201IRB20
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical intervention study is to construct a neonatal skin contact program for cesarean section primipara families with the cooperation of both parents.So as to provide theoretical basis and practical guidance for pregnant women and their spouses, and reduce the possibility of anxiety and depression of pregnant women and their spouses. Promoting the ability of fathers to participate in co-parenting can help mothers and their spouses adapt to the new role of ' parents ' and enhance their sense of parenting competence and happiness. The main questions it aims to answer are:

• How to publicize and educate knowledge about co-parenting theory and skin contact knowledge and use the co-parenting theory to design a suitable skin contact scheme?
• What are the benefits of skin to skin contact between parents after cesarean section?
• Participants will take prenatal classes on co-parenting and skin to skin contact.
• Participants will receive brochures on co-parenting theory and skin to skin contact.
• Participants will receive face-to-face skin-to-skin contact guidance every day during postpartum hospitalization to correctly perform skin to skin contact.
• Participants will be online to punch in skin contact. There is a comparison group: routine prenatal and post-natal care without additional educational support.

Conditions

Postpartum Anxiety; Parturition; Precipitate

Keywords

Paternity; Skin-to-skin contact; Co-parenting; Parents' psychological health

Outcome Measures

Primary Outcomes (5)

• Postpartum parents ' sense of security (Postpartum Parental Safety Scale，PPSS)

  Postpartum Parental Safety Scale，PPSS is a survey tool used to assess the sense of security of both parents after childbirth, and to assess the sense of security of parents in the first week after delivery.The Chinese version of PPSS scale is divided into mother version and father version.The PPSS mother version had 18 items and the father version had 13 items, all of which were scored using a four-level scoring method ( 1-4 points ). Mother version of the scale minimum score of eighteen points, the highest score of seventy-two ; the minimum score of the father 's version scale is 13 points, and the maximum score is 52 points.The answer options ranged from ' very disagree ' to ' very agree '. The higher the score, the higher the sense of security.

  one week after delivery

• Co-parenting situation (The Brief Coparenting Relationship Scale， Brief CRS )

  The Brief Coparenting Relationship Scale ( Brief CRS ) was jointly developed by Feinberg, Brown and Kan in 2012. The scale uses a self-reported approach to comprehensively assess the quality of coparenting in a family. It consists of 14 items and 7 subscales.The Brief Coparenting Relationship Scale can be used as a tool to measure the effect of father in coparenting in Chinese family． The scale can be used to measure father's support and involvement with breastfeeding in the study of breastfeeding．All items were scored by Likert 7, of which 3 items were reverse scoring, with a total score of 0-84. The higher the score, the better the co-parenting, that is, the stronger the father 's support.

  42 days and three months after delivery

• Maternal and infant attachment

  The Maternal Postnatal Attachment Scale ( MPAS ) is a self-reported scale developed by Condon and Corkindale to reflect the degree of subjective emotional connection between mothers and their infants.The Maternal Postnatal Attachment Scale is a valid and reliable tool for the evaluation of the early affectionate mother-infant relationship.The scale has 18 items, including two, three, four and five options.The total score span of the scale is between 18-90, and the higher the score, the higher the level of maternal and child attachment.

  42 days and three months after delivery

• Father-infant attachment

  Father-infant attachment will be evaluated by the use of the Paternal Postnatal Attachment Scale (PPAS) originally designed by John T. Condon and colleagues. This is a 19-item, self-report questionnaire including three subscales: patience and tolerance, pleasure in interaction, and affection and pride.The total score span of the scale is between 19-95, and the higher the score, the higher the level of attachment between father and baby.

  42 days and three months after delivery

• Neonatal Behaviral Neurological Assessment，NBNA

  French Ameil Tison neonatal neuromotor examination method, combined with the specific situation in China.It is also of great significance for understanding the behavioral abilities of newborns, promoting early development of eugenics and intellectual cognition.NBNA examination is divided into five parts, including six items of neonatal behavioral ability, four items of passive muscle tone, four items of active muscle tone, three items of Primitive reflexes, and three items of general response, with a total of 40 points. The higher the score, the better the behavioral neurological function.

  3 days and 42 days after delivery

Secondary Outcomes (2)

• The anxiety level

  one week,42 days and three months after delivery

• The depression level

  one week,42 days and three months after delivery

Study Arms (2)

Skin to skin contact and co-parenting theory course

EXPERIMENTAL

1. Skin to skin contact and co-parenting theory course 2. Skin to skin contact instruction manual and co-parenting theory brochure 3. Daily face-to-face skin to skin contact guidance during hospitalization 4. Online punching skin to skin contact

Behavioral: Skin to skin contact and co-parenting theory course; Behavioral: Skin to skin contact instruction manual and co-parenting theory brochure; Behavioral: Daily face-to-face skin to skin contact guidance during hospitalization; Behavioral: Online punching skin to skin contact

Routine obstetric care

OTHER

Routine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc.

Behavioral: Routine obstetric care

Interventions

Skin to skin contact and co-parenting theory course BEHAVIORAL

On the day before delivery, pregnant women and their husbands attend a course on the theory of skin contact and co-parenting to explain the role and importance of skin contact ; to understand the knowledge of co-parenting and parenting care ; to learn the communication method and future parenting plan based on the theory of co-parenting, and to learn the operation of skin contact with newborns after delivery.

Skin to skin contact and co-parenting theory course

Skin to skin contact instruction manual and co-parenting theory brochure BEHAVIORAL

According to reading and analyzing the literature on skin contact, summarize the content of skin contact operation guidance ; read and analyze the relevant literature of co-parenting theory, and summarize the theoretical knowledge and practical operation methods of co-parenting. Pregnant women and their spouses can check in time.

Skin to skin contact and co-parenting theory course

Daily face-to-face skin to skin contact guidance during hospitalization BEHAVIORAL

After delivery, face-to-face skin-to-skin contact guidance and co-parenting communication and practice were given to the parturient and her husband on a daily basis during hospitalization. Establish a daily fixed skin contact duration target, and the specific operation is freely allocated by both parents.

Skin to skin contact and co-parenting theory course

Online punching skin to skin contact BEHAVIORAL

Share common parenting related knowledge, daily skin contact reminders, emphasize mutual recognition and mutual support of parents, and conduct WeChat follow-up every two weeks to understand the physical and mental status of both parties and the growth of infants.

Skin to skin contact and co-parenting theory course

Routine obstetric care BEHAVIORAL

Routine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc.

Routine obstetric care

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primipara
• cesarean section
• weeks of pregnancy
• junior high school education or above
• Couples live together
• Both husband and wife can recognize and understand Chinese

You may not qualify if:

• multiple pregnancy
• Pregnant women have serious complications / complications, such as eclampsia, postpartum hemorrhage, severe cardiopulmonary dysfunction, etc.
• Prenatal examination of the fetus with chromosomal abnormalities or possible malformations
• One of the couple has mental retardation or mental disorders can not cooperate
• Delivery before 37 weeks of gestation
• Postpartum mother-to-child separation, newborns need to be treated and monitored in NICU
• Evaluation information collection is not perfect

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Medical College Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

Related Publications (30)

• Feinberg ME, Brown LD, Kan ML. A Multi-Domain Self-Report Measure of Coparenting. Parent Sci Pract. 2012 Jan 1;12(1):1-21. doi: 10.1080/15295192.2012.638870. Epub 2012 Jan 20.

  PMID: 23166477 BACKGROUND

• Schoppe-Sullivan SJ, Weldon AH, Cook JC, Davis EF, Buckley CK. Coparenting behavior moderates longitudinal relations between effortful control and preschool children's externalizing behavior. J Child Psychol Psychiatry. 2009 Jun;50(6):698-706. doi: 10.1111/j.1469-7610.2008.02009.x. Epub 2009 Jan 21.

  PMID: 19207627 BACKGROUND

• Takeishi Y, Nakamura Y, Kawajiri M, Atogami F, Yoshizawa T. Developing a Prenatal Couple Education Program Focusing on Coparenting for Japanese Couples: A Quasi-Experimental Study. Tohoku J Exp Med. 2019 Sep;249(1):9-17. doi: 10.1620/tjem.249.9.

  PMID: 31511452 BACKGROUND

• Woody CA, Ferrari AJ, Siskind DJ, Whiteford HA, Harris MG. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. J Affect Disord. 2017 Sep;219:86-92. doi: 10.1016/j.jad.2017.05.003. Epub 2017 May 8.

  PMID: 28531848 BACKGROUND

• Cameron EE, Sedov ID, Tomfohr-Madsen LM. Prevalence of paternal depression in pregnancy and the postpartum: An updated meta-analysis. J Affect Disord. 2016 Dec;206:189-203. doi: 10.1016/j.jad.2016.07.044. Epub 2016 Jul 20.

  PMID: 27475890 BACKGROUND

• Philpott LF, Corcoran P. Paternal postnatal depression in Ireland: Prevalence and associated factors. Midwifery. 2018 Jan;56:121-127. doi: 10.1016/j.midw.2017.10.009. Epub 2017 Oct 20.

  PMID: 29096280 BACKGROUND

• Moneta C ME. [Attachment and loss: rediscovering John Bowlby]. Rev Chil Pediatr. 2014 Jun;85(3):265-8. doi: 10.4067/S0370-41062014000300001. No abstract available. Spanish.

  PMID: 25697242 BACKGROUND

• Kerns KA, Brumariu LE. Is Insecure Parent-Child Attachment a Risk Factor for the Development of Anxiety in Childhood or Adolescence? Child Dev Perspect. 2014 Mar 1;8(1):12-17. doi: 10.1111/cdep.12054.

  PMID: 24660023 BACKGROUND

• Benoit D. Infant-parent attachment: Definition, types, antecedents, measurement and outcome. Paediatr Child Health. 2004 Oct;9(8):541-545. doi: 10.1093/pch/9.8.541.

  PMID: 19680481 BACKGROUND

• Feinberg ME, Kan ML. Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations. J Fam Psychol. 2008 Apr;22(2):253-63. doi: 10.1037/0893-3200.22.2.253.

  PMID: 18410212 BACKGROUND

• Feinberg ME, Jones DE, Hostetler ML, Roettger ME, Paul IM, Ehrenthal DB. Couple-Focused Prevention at the Transition to Parenthood, a Randomized Trial: Effects on Coparenting, Parenting, Family Violence, and Parent and Child Adjustment. Prev Sci. 2016 Aug;17(6):751-64. doi: 10.1007/s11121-016-0674-z.

  PMID: 27334116 BACKGROUND

• Izett E, Rooney R, Prescott SL, De Palma M, McDevitt M. Prevention of Mental Health Difficulties for Children Aged 0-3 Years: A Review. Front Psychol. 2021 Sep 29;11:500361. doi: 10.3389/fpsyg.2020.500361. eCollection 2020.

  PMID: 34777074 BACKGROUND

• Allport-Altillo BS, Aqil AR, Nelson T, Johnson SB, Labrique AB, Carabas Y, Marcell AV. Parents' Perspectives on Supporting Father Involvement in African American Families During Pregnancy and Early Infancy. J Natl Med Assoc. 2020 Aug;112(4):344-361. doi: 10.1016/j.jnma.2020.04.002. Epub 2020 May 11.

  PMID: 32409095 BACKGROUND

• Shorey S, Dennis CL, Bridge S, Chong YS, Holroyd E, He HG. First-time fathers' postnatal experiences and support needs: A descriptive qualitative study. J Adv Nurs. 2017 Dec;73(12):2987-2996. doi: 10.1111/jan.13349. Epub 2017 Jun 21.

  PMID: 28557020 BACKGROUND

• Shorey S, Lau Y, Dennis CL, Chan YS, Tam WWS, Chan YH. A randomized-controlled trial to examine the effectiveness of the 'Home-but not Alone' mobile-health application educational programme on parental outcomes. J Adv Nurs. 2017 Sep;73(9):2103-2117. doi: 10.1111/jan.13293. Epub 2017 Apr 7.

  PMID: 28276086 BACKGROUND

• Jarjour IT. Neurodevelopmental outcome after extreme prematurity: a review of the literature. Pediatr Neurol. 2015 Feb;52(2):143-52. doi: 10.1016/j.pediatrneurol.2014.10.027. Epub 2014 Nov 4.

  PMID: 25497122 BACKGROUND

• Baron IS, Litman FR, Ahronovich MD, Baker R. Late preterm birth: a review of medical and neuropsychological childhood outcomes. Neuropsychol Rev. 2012 Dec;22(4):438-50. doi: 10.1007/s11065-012-9210-5. Epub 2012 Aug 7.

  PMID: 22869055 BACKGROUND

• Mori R, Khanna R, Pledge D, Nakayama T. Meta-analysis of physiological effects of skin-to-skin contact for newborns and mothers. Pediatr Int. 2010 Apr;52(2):161-70. doi: 10.1111/j.1442-200X.2009.02909.x. Epub 2009 Jun 11.

  PMID: 19519670 BACKGROUND

• Feldman R, Eidelman AI. Skin-to-skin contact (Kangaroo Care) accelerates autonomic and neurobehavioural maturation in preterm infants. Dev Med Child Neurol. 2003 Apr;45(4):274-81. doi: 10.1017/s0012162203000525.

  PMID: 12647930 BACKGROUND

• Ferber SG, Makhoul IR. The effect of skin-to-skin contact (kangaroo care) shortly after birth on the neurobehavioral responses of the term newborn: a randomized, controlled trial. Pediatrics. 2004 Apr;113(4):858-65. doi: 10.1542/peds.113.4.858.

  PMID: 15060238 BACKGROUND

• Charpak N, Ruiz JG, Zupan J, Cattaneo A, Figueroa Z, Tessier R, Cristo M, Anderson G, Ludington S, Mendoza S, Mokhachane M, Worku B. Kangaroo Mother Care: 25 years after. Acta Paediatr. 2005 May;94(5):514-22. doi: 10.1111/j.1651-2227.2005.tb01930.x.

  PMID: 16188735 BACKGROUND

• Pillai Riddell RR, Racine NM, Gennis HG, Turcotte K, Uman LS, Horton RE, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Lisi DM. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2015 Dec 2;2015(12):CD006275. doi: 10.1002/14651858.CD006275.pub3.

  PMID: 26630545 BACKGROUND

• Feldman R, Eidelman AI, Sirota L, Weller A. Comparison of skin-to-skin (kangaroo) and traditional care: parenting outcomes and preterm infant development. Pediatrics. 2002 Jul;110(1 Pt 1):16-26. doi: 10.1542/peds.110.1.16.

  PMID: 12093942 BACKGROUND

• Anderzen-Carlsson A, Lamy ZC, Eriksson M. Parental experiences of providing skin-to-skin care to their newborn infant--part 1: a qualitative systematic review. Int J Qual Stud Health Well-being. 2014 Oct 13;9:24906. doi: 10.3402/qhw.v9.24906. eCollection 2014.

  PMID: 25319746 BACKGROUND

• Velandia M, Uvnas-Moberg K, Nissen E. Sex differences in newborn interaction with mother or father during skin-to-skin contact after Caesarean section. Acta Paediatr. 2012 Apr;101(4):360-7. doi: 10.1111/j.1651-2227.2011.02523.x. Epub 2011 Dec 1.

  PMID: 22077187 BACKGROUND

• Erlandsson K, Dsilna A, Fagerberg I, Christensson K. Skin-to-skin care with the father after cesarean birth and its effect on newborn crying and prefeeding behavior. Birth. 2007 Jun;34(2):105-14. doi: 10.1111/j.1523-536X.2007.00162.x.

  PMID: 17542814 BACKGROUND

• Shorey S, He HG, Morelius E. Skin-to-skin contact by fathers and the impact on infant and paternal outcomes: an integrative review. Midwifery. 2016 Sep;40:207-17. doi: 10.1016/j.midw.2016.07.007. Epub 2016 Jul 5.

  PMID: 27476026 BACKGROUND

• Erlandsson K, Christensson K, Fagerberg I. Fathers' lived experiences of getting to know their baby while acting as primary caregivers immediately following birth. J Perinat Educ. 2008 Spring;17(2):28-36. doi: 10.1624/105812408X298363.

  PMID: 19252686 BACKGROUND

• Makela H, Axelin A, Feeley N, Niela-Vilen H. Clinging to closeness: The parental view on developing a close bond with their infants in a NICU. Midwifery. 2018 Jul;62:183-188. doi: 10.1016/j.midw.2018.04.003. Epub 2018 Apr 11.

  PMID: 29684798 BACKGROUND

• Olsson E, Eriksson M, Anderzen-Carlsson A. Skin-to-Skin Contact Facilitates More Equal Parenthood - A Qualitative Study From Fathers' Perspective. J Pediatr Nurs. 2017 May-Jun;34:e2-e9. doi: 10.1016/j.pedn.2017.03.004. Epub 2017 Mar 29.

  PMID: 28364962 BACKGROUND

Related Links

• A website providing emotional guidance and support for new parents

Study Officials

• Xuejun Tian

  Head Nurse of Obstetrics at Jiangnan University Affiliated Hospital

  STUDY DIRECTOR

• Lingxia Kong

  A student of Wuxi Medical College Jiangnan University

  STUDY CHAIR

• Xiao Chen, Doctor

  Professor at Jiangnan University

  STUDY DIRECTOR

• Yuting Jiang

  A student of Wuxi Medical College Jiangnan University

  PRINCIPAL INVESTIGATOR

• Chunting Li

  A student of Wuxi Medical College Jiangnan University

  STUDY CHAIR

• Qian Wang

  A student of Wuxi Medical College Jiangnan University

  STUDY CHAIR

• Xian Ding, Doctor

  Associate Professor at Jiangnan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Anesthesiology

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 27, 2023
• Study Start: May 9, 2023
• Primary Completion: October 21, 2023
• Study Completion: January 14, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)