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

Postpartum Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05785806
• Other study ID #: JNU20221201IRB20
• Status: Completed
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: January 14, 2024

Study information

• Verified date: January 2024
• Source: Affiliated Hospital of Jiangnan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 14, 2024
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Parturition; Precipitate
• Postpartum Anxiety

Intervention

Behavioral:
• Skin to skin contact and co-parenting theory course
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 instruction manual and co-parenting theory brochure
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.
• Daily face-to-face skin to skin contact guidance during hospitalization
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.
• Online punching skin to skin contact
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.
• Routine obstetric care
Routine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc.

Locations

Country	Name	City	State
China	Medical College Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The anxiety level	The Self-Rating Anxiety Scale,SAS will be used by both parents to assess the anxiety levels.The self-rating anxiety scale compiled by Zung in 1971 is a self-rating scale, which is used to evaluate the subjective feelings of adults and the degree of anxiety. The scale includes 20 items, including 15 positive scores and 5 negative scores. According to the frequency of symptoms defined by the item, the Likert 4-level scoring method was used. From ' no or little time ' to ' most or all of the time ', the positive scoring questions were rated as 1-4 points, and the reverse scoring questions were rated as 4-1 points. Standard score = total coarse score * 1.25, take the integer part, with SAS standard as the cut-off value, the cut-off value is less than 50 points for no anxiety group, 50 ~ 59 points for mild anxiety group, 60 ~ 69 points for moderate anxiety group, 69 points or more for severe anxiety group.	one week,42 days and three months after delivery
Secondary	The depression level	The Self-Rating Depression Scale,SDS will be used by both parents to assess the depression level.Self-Rating Depression Scale ( SDS ) is a self-rating scale compiled by Zung in 1965, which is used to evaluate the subjective feelings of adults and the severity of depression. It includes 20 items, using a 4-level score, 10 positive score items, and 10 reverse score items. The total rough score was obtained by adding the scores of 20 items. The standard score = total rough score * 1.25, and the integer part was taken. The standard value of SDS was divided into the boundary value. The boundary value was less than 53, which was divided into the non-depression group, 53-62 was divided into the mild depression group, 63-72 was divided into the moderate depression group, and more than 72 was the severe depression group.	one week,42 days and three months after delivery

External Links

•   A website providing emotional guidance and support for new parents