Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth
NCT ID: NCT05285215
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1480 participants
INTERVENTIONAL
2022-04-18
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Integrated psychological program (IPP) group
Patients are assigned to have mindfulness training and music listening before and after delivery. Video counselling will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.
Integrated psychological program (IPP)
Patients will listen to the music for 30 minutes before delivery, and resume music listening once they are comfortable after delivery. Upon discharge, they will be asked to have music listening at least 30 minutes per day until 8 weeks postnatal survey.
Mindfulness training via mobile application is administered before delivery. After delivery, they are asked to perform mindfulness training for 10 minutes daily, until last follow-up at 8 weeks post-delivery.
Mobile electronic survey will be used to assess patients' EPDS scores fortnightly, until the last follow-up at week 8 post-delivery. If the EPDS scoring is found to be equal to or more than 10, video counselling and/or face-to-face consultation will be arranged.
Video counselling sessions will be offered if patients are found to have EPDS score of 10-12. For women found to have EPDS≥13, a face-to-face initial psychiatry consultation will be conducted.
Non- Integrated psychological program (IPP) group
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.
No interventions assigned to this group
Interventions
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Integrated psychological program (IPP)
Patients will listen to the music for 30 minutes before delivery, and resume music listening once they are comfortable after delivery. Upon discharge, they will be asked to have music listening at least 30 minutes per day until 8 weeks postnatal survey.
Mindfulness training via mobile application is administered before delivery. After delivery, they are asked to perform mindfulness training for 10 minutes daily, until last follow-up at 8 weeks post-delivery.
Mobile electronic survey will be used to assess patients' EPDS scores fortnightly, until the last follow-up at week 8 post-delivery. If the EPDS scoring is found to be equal to or more than 10, video counselling and/or face-to-face consultation will be arranged.
Video counselling sessions will be offered if patients are found to have EPDS score of 10-12. For women found to have EPDS≥13, a face-to-face initial psychiatry consultation will be conducted.
Eligibility Criteria
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Inclusion Criteria
* parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
* with a singleton fetus;
* to have delivery in this institution.
Exclusion Criteria
* history of intravenous drug or opioid abuse;
* previous history of chronic pain syndrome.
21 Years
50 Years
FEMALE
No
Sponsors
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KK Women's and Children's Hospital
OTHER_GOV
Responsible Party
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Sng Ban Leong
Head of Department, Women's Anaesthesia
Principal Investigators
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Ban Leong Sng
Role: PRINCIPAL_INVESTIGATOR
KK Women's and Children's Hospital
Locations
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KK Women's and Children's Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Ban Leong Sng
Role: primary
Other Identifiers
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CSAINV21jun-0008
Identifier Type: -
Identifier Source: org_study_id
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