Clinical trial NCT05785806: Parent Infant Skin-to-Skin Contact Intervention Based on The Co-parenting Theory
Official title: Construction and Effect Evaluation of Parent Infant Skin-to-Skin Contact Intervention Program Based on The Co-parenting Theory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Anxiety
Parturition; Precipitate
Keywords: Paternity
Skin-to-skin contact
Co-parenting
Parents' psychological health
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 111
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postpartum parents ' sense of security (Postpartum Parental Safety Scale，PPSS)
timeFrame: one week after delivery
measure: Co-parenting situation (The Brief Coparenting Relationship Scale， Brief CRS )
timeFrame: 42 days and three months after delivery
measure: Maternal and infant attachment
timeFrame: 42 days and three months after delivery
measure: Father-infant attachment
timeFrame: 42 days and three months after delivery
measure: Neonatal Behaviral Neurological Assessment，NBNA
timeFrame: 3 days and 42 days after delivery
Secondary outcomes:
measure: The anxiety level
timeFrame: one week,42 days and three months after delivery
measure: The depression level
timeFrame: one week,42 days and three months after delivery
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Medical College Jiangnan University
state: Jiangsu
Study officials:
affiliation: Head Nurse of Obstetrics at Jiangnan University Affiliated Hospital
name: Xuejun Tian
role: STUDY_DIRECTOR
affiliation: A student of Wuxi Medical College Jiangnan University
name: Lingxia Kong
role: STUDY_CHAIR
affiliation: Professor at Jiangnan University
name: Xiao Chen, Doctor
role: STUDY_DIRECTOR
affiliation: A student of Wuxi Medical College Jiangnan University
name: Yuting Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: A student of Wuxi Medical College Jiangnan University
name: Chunting Li
role: STUDY_CHAIR
affiliation: A student of Wuxi Medical College Jiangnan University
name: Qian Wang
role: STUDY_CHAIR
affiliation: Associate Professor at Jiangnan University
name: Xian Ding, Doctor
role: STUDY_DIRECTOR
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