Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05285215
Status:
RECRUITING
Last Update Posted:
2023-08-09
First Post:
2022-03-09
Brief Title:
Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth CODEPAD - II Collaborative Outcomes of DEpression and Pain Associated With Delivery- II
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CODEPAD-II
Brief Summary:
The integrated psychological program IPP is based on evidence from the local population showing that the interventional components mindfulness training music listening video counselling are amenable to implementation in the outpatient care setting Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic The proposal will transform the healthcare model for treating postnatal depression PND and persistent postpartum pain PPP
Detailed Description:
The childbirth process is associated with the risk of developing postnatal depression PND and persistent postpartum pain PPP which could contribute to maternal morbidity There is a lack of routine structured and effective programs in current practice to monitor and effectively manage PND and PPP Pilot study found specific pain and psychological vulnerability factors associated with increased risk of PND after childbirth
The investigators propose an integrated psychological program IPP consisting of mindfulness mobile application music listening digital health video counselling and mobile electronic survey to effectively prevent detect monitor and treat PND and PPP The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale EPDS scores in a subgroup of laboring women with outcomes of vaginal or emergency Cesarean delivery that may have increased risk factors for PND The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes mother-child bonding breastfeeding self-efficacy quality of life A total of 1480 women undergoing childbirth will be recruited in this randomized controlled trial
This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP The IPP will also provide patient-centered care tailored to the individuals needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health
The investigators propose an integrated psychological program IPP consisting of mindfulness mobile application music listening digital health video counselling and mobile electronic survey to effectively prevent detect monitor and treat PND and PPP The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale EPDS scores in a subgroup of laboring women with outcomes of vaginal or emergency Cesarean delivery that may have increased risk factors for PND The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes mother-child bonding breastfeeding self-efficacy quality of life A total of 1480 women undergoing childbirth will be recruited in this randomized controlled trial
This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP The IPP will also provide patient-centered care tailored to the individuals needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None