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Clinical Trials/NCT05785806
NCT05785806
Completed
N/A

Construction and Effect Evaluation of Parent Infant Skin-to-Skin Contact Intervention Program Based on The Co-parenting Theory

Affiliated Hospital of Jiangnan University1 site in 1 country111 target enrollmentMay 9, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postpartum Anxiety
Sponsor
Affiliated Hospital of Jiangnan University
Enrollment
111
Locations
1
Primary Endpoint
Maternal and infant attachment
Status
Completed
Last Updated
2 years ago

Overview

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?

    1. Participants will take prenatal classes on co-parenting and skin to skin contact.
    2. Participants will receive brochures on co-parenting theory and skin to skin contact.
    3. Participants will receive face-to-face skin-to-skin contact guidance every day during postpartum hospitalization to correctly perform skin to skin contact.
    4. Participants will be online to punch in skin contact. There is a comparison group: routine prenatal and post-natal care without additional educational support.

Researchers will compare the comparison group to see the cesarean section parents in the postpartum distribution of skin contact tasks, joint skin contact, whether will the intimate relationship between parents and infants, parents ' mental health, anxiety level.

Detailed Description

Through pre-clinical research, it was found that primipara families lacked guidance and intervention for fathers, and theoretical basis and practical guidance were needed to build a new family system at the first time after delivery. Pregnant women need the support and help of their spouses or family members in the critical period of physical and mental recovery after delivery ; the newborn needs daily life care, interactive communication and caring companionship to meet the physical, emotional and psychological needs of the baby ; the parental participation of primipara spouses is at a low level. Maternal spouses lack relevant knowledge and experience, and need targeted guidance and intervention to promote their parental participation. After the mother underwent cesarean section, due to physical factors such as pain and fetal crying, the mother 's mood is affected, and the arrival of a new life is full of anxiety, which will lead to problems in the mother 's lactation. Production and childrearing are not the task of the mother alone. The purpose of this study is to let the father participate in childrearing at the first time after childbirth, and what are the benefits to the family.

Registry
clinicaltrials.gov
Start Date
May 9, 2023
End Date
January 14, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Affiliated Hospital of Jiangnan University
Responsible Party
Principal Investigator
Principal Investigator

chen xiao

Chief Physician of Anesthesiology

Affiliated Hospital of Jiangnan University

Eligibility Criteria

Inclusion Criteria

  • Primipara
  • cesarean section
  • 37-42 weeks of pregnancy
  • junior high school education or above
  • Couples live together
  • Both husband and wife can recognize and understand Chinese

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Maternal and infant attachment

Time Frame: 42 days and three months after delivery

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.

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

Time Frame: one week after delivery

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.

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

Time Frame: 42 days and three months after delivery

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.

Father-infant attachment

Time Frame: 42 days and three months after delivery

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.

Neonatal Behaviral Neurological Assessment,NBNA

Time Frame: 3 days and 42 days after delivery

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.

Secondary Outcomes

  • The depression level(one week,42 days and three months after delivery)
  • The anxiety level(one week,42 days and three months after delivery)

Study Sites (1)

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