Clinical trial NCT05285215: Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-17
Enrollment: 1480
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.

Eligibility criteria: Inclusion Criteria:

* healthy (American Society of Anesthesiologists physical status 2)
* parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
* with a singleton fetus;
* to have delivery in this institution.

Exclusion Criteria:

* current active psychiatric care;
* history of intravenous drug or opioid abuse;
* previous history of chronic pain syndrome.

Primary outcomes:
measure: The incidence of postnatal depression in both groups
timeFrame: 8 weeks after delivery (2 months)
measure: The incidence of persistent postpartum pain (PPP) in both groups
timeFrame: 8 weeks after delivery (2 months)
Secondary outcomes:
measure: Breastfeeding self-efficacy in both groups
timeFrame: 8 weeks after delivery (2 months)
measure: Postpartum bonding in both groups
timeFrame: 8 weeks after delivery (2 months)
measure: Health status in both groups
timeFrame: 8 weeks after delivery (2 months)
Other outcomes:
measure: Matching between intention and actual use of labor epidural analgesia
timeFrame: 1 day (during labor and delivery)
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng
role: PRINCIPAL_INVESTIGATOR
References: