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

January 18, 2024 updated by: chen xiao, Affiliated Hospital of Jiangnan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Medical College Jiangnan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin to skin contact and co-parenting theory course
  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
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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Other: Routine obstetric care
Routine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc.
Behavioral: Routine obstetric care
Routine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
42 days and three months after delivery
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.
42 days and three months after delivery
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.
42 days and three months after delivery
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.
one week after delivery
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.
3 days and 42 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The anxiety level
Time Frame: one week,42 days and three months after delivery
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
The depression level
Time Frame: one week,42 days and three months after delivery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Jiangnan University

Investigators

  • Study Chair: Lingxia Kong, A student of Wuxi Medical College Jiangnan University
  • Study Chair: Chunting Li, A student of Wuxi Medical College Jiangnan University
  • Study Chair: Qian Wang, A student of Wuxi Medical College Jiangnan University
  • Study Director: Xuejun Tian, Head Nurse of Obstetrics at Jiangnan University Affiliated Hospital
  • Study Director: Xiao Chen, Doctor, Professor at Jiangnan University
  • Principal Investigator: Yuting Jiang, A student of Wuxi Medical College Jiangnan University
  • Study Director: Xian Ding, Doctor, Associate Professor at Jiangnan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Actual)

October 21, 2023

Study Completion (Actual)

January 14, 2024

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JNU20221201IRB20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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