Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth

NCT05285215 | Completed

• 1 other identifier: CSAINV21jun-0008
• Study Type: interventional
• Target: 1,720
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (2)

• The incidence of postnatal depression in both groups

  Incidence of postnatal depression will be assessed via Edinburgh Postnatal Depression Scale (EPDS) score at week 8 after delivery. EPDS is a 10-item self reporting scale to evaluate the postnatal depression. Participants are asked to respond according to how they have felt in the past seven days. Each item is measured on a 4-point scale (0-3), with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 10 and above indicates clinically significant depressive symptoms.

  8 weeks after delivery (2 months)

• The incidence of persistent postpartum pain (PPP) in both groups

  The incidence of PPP is defined as the presence of pain for 8 weeks at the perineal, surgical scar or abdominal region related to childbirth at week 8 after delivery.

  8 weeks after delivery (2 months)

Secondary Outcomes (3)

• Breastfeeding self-efficacy in both groups

  8 weeks after delivery (2 months)

• Postpartum bonding in both groups

  8 weeks after delivery (2 months)

• Health status in both groups

  8 weeks after delivery (2 months)

Other Outcomes (1)

• Matching between intention and actual use of labor epidural analgesia

  1 day (during labor and delivery)

Study Arms (2)

Integrated psychological program (IPP) group

EXPERIMENTAL

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.

Procedure: Integrated psychological program (IPP)

Non- Integrated psychological program (IPP) group

NO INTERVENTION

Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.

Interventions

Integrated psychological program (IPP) PROCEDURE

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.

Integrated psychological program (IPP) group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Only pregnant patients giving birth in the institution will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ban Leong Sng

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, Women's Anaesthesia

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: April 18, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 5, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)