Postpartum AnxietyNCT05785806
Parent Infant Skin-to-Skin Contact Intervention Based on The Co-parenting Theory
A study testing Skin to skin contact and co-parenting theory course, Skin to skin contact instruction manual and co-parenting theory brochure and Daily face-to-face skin to skin contact guidance during hospitalization in people with Postpartum Anxiety and Parturition; Precipitate, run by Affiliated Hospital of Jiangnan University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anxiety, Parturition; Precipitate
- What is being tested?
- Skin to skin contact and co-parenting theory course, Skin to skin contact instruction manual and co-parenting theory brochure and Daily face-to-face skin to skin contact guidance during hospitalization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to 14 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
- 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.
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.
Read the 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.
- Conditions
- Postpartum Anxiety, Parturition; Precipitate
- Being tested
- Skin to skin contact and co-parenting theory course, Skin to skin contact instruction manual and co-parenting theory brochure, Daily face-to-face skin to skin contact guidance during hospitalization, Online punching skin to skin contact, Routine obstetric care
- Keywords
- Paternity, Skin-to-skin contact, Co-parenting, Parents' psychological health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin to skin contact and co-parenting theory courseBehavioural
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 brochureBehavioural
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 hospitalizationBehavioural
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 contactBehavioural
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 careBehavioural
Routine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Routine obstetric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 days and 42 days after delivery
Secondary outcomes (2)
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.
Measured: one week,42 days and three months after delivery
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.
Measured: one week,42 days and three months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start9 May 2023
- Primary completion21 Oct 2023
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chen xiao, Affiliated Hospital of Jiangnan University
- Investigators
- Xuejun Tian, Study director, Head Nurse of Obstetrics at Jiangnan University Affiliated HospitalLingxia Kong, Study chair, A student of Wuxi Medical College Jiangnan UniversityXiao Chen, Doctor, Study director, Professor at Jiangnan UniversityYuting Jiang, Principal investigator, A student of Wuxi Medical College Jiangnan UniversityChunting Li, Study chair, A student of Wuxi Medical College Jiangnan UniversityQian Wang, Study chair, A student of Wuxi Medical College Jiangnan UniversityXian Ding, Doctor, Study director, Associate Professor at Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785806
- Sponsor's protocol ID
- JNU20221201IRB20
- Status last verified
- Jan 2024
- First submitted
- 2 Mar 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23166477Schoppe-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.
PubMed 19207627Takeishi 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.
PubMed 31511452Woody 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.
PubMed 28531848Cameron 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.
PubMed 27475890Philpott 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.
PubMed 29096280Moneta 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.
PubMed 25697242Kerns 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.
PubMed 24660023Benoit 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.
PubMed 19680481Feinberg 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.
PubMed 18410212Feinberg 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.
PubMed 27334116Izett 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.
PubMed 34777074Allport-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.
PubMed 32409095Shorey 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.
PubMed 28557020Shorey 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.
PubMed 28276086
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Effect Evaluation of Parent Infant Skin-to-Skin Contact Intervention Program Based on The Co-parenting Theory
- ClinicalTrials.gov ID
- NCT05785806
- Acronym / sponsor ID
- JNU20221201IRB20
- Conditions
- Postpartum Anxiety, Parturition; Precipitate
- Keywords
- Paternity, Skin-to-skin contact, Co-parenting, Parents' psychological health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin to skin contact and co-parenting theory course | Experimental | 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 contact1. 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 |
| Routine obstetric care | Other | Behavioral: Routine obstetric careRoutine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primipara
- cesarean section
- 37-42 weeks of pregnancy
- junior high school education or above
- Couples live together
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin to skin contact and co-parenting theory courseOn 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. | Behavioural | Skin to skin contact and co-parenting theory course |
| Skin to skin contact instruction manual and co-parenting theory brochureAccording 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. | Behavioural | Skin to skin contact and co-parenting theory course |
| Daily face-to-face skin to skin contact guidance during hospitalizationAfter 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. | Behavioural | Skin to skin contact and co-parenting theory course |
| Online punching skin to skin contactShare 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. | Behavioural | Skin to skin contact and co-parenting theory course |
| Routine obstetric careRoutine prenatal training and postpartum education, including basic breastfeeding guidelines, touching, etc. | Behavioural | Routine obstetric care |
Primary outcome
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.
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.
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.
2 secondary outcomes
The anxiety level
Time frame: one week,42 days and three months after delivery
The depression level
Time frame: one week,42 days and three months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 23166477Feinberg 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.
- Background: PubMed 19207627Schoppe-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.
- Background: PubMed 31511452Takeishi 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.
- Background: PubMed 28531848Woody 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.
- Background: PubMed 27475890Cameron 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.
- Background: PubMed 29096280Philpott 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.
- Background: PubMed 25697242Moneta 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.
- Background: PubMed 24660023Kerns 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.
- Background: PubMed 19680481Benoit 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.
- Background: PubMed 18410212Feinberg 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.
- Background: PubMed 27334116Feinberg 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.
- Background: PubMed 34777074Izett 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.
- A website providing emotional guidance and support for new parentsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuejun Tian study director
Head Nurse of Obstetrics at Jiangnan University Affiliated Hospital
Lingxia Kong study chair
A student of Wuxi Medical College Jiangnan University
Xiao Chen, Doctor study director
Professor at Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin to skin contact and co-parenting theory course, Skin to skin contact instruction manual and co-parenting theory brochure and Daily face-to-face skin to skin contact guidance during hospitalization in people with Postpartum Anxiety and Parturition; Precipitate, run by Affiliated Hospital of Jiangnan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum parents ' sense of security (Postpartum Parental Safety Scale，PPSS) (time frame: one week after delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05785806, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.