CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III) (CODEPAD-III)
Collaborative Psychological Model for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)
The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after childbirth.
The study site proposes a Collaborative Psychological Model (CPM) consisting of music listening, customized mobile application on psychological strategies, telephone-based support, with monitoring (mobile electronic surveys, wearable-based vital sign monitoring) to effectively prevent, detect, monitor, and treat depression and persistent pain after childbirth. The study will determine if using the CPM will reduce the risk of having depression associated with childbirth. The study will also find out whether the CPM will reduce the depressive symptoms in women who undergo labor that may have increased depression risk. This clinical study will involve 2042 women undergoing childbirth at KK Hospital. In addition, up to 1428 patients' partners (fathers) will also be recruited for the week 8 postpartum assessment.
The study findings will improve healthcare for women in the community by incorporating digital psychological strategies to manage depression and persistent pain after childbirth. The CPM will also guide future directions to customize an individual's healthcare needs and to improve transition from hospital to community care for women after childbirth.
연구 개요
상태
상세 설명
Postnatal depression (PND) represents a substantial burden, contributing to adverse outcomes for mothers, their infants, and families. The global incidence of PND has been reported to be about 17%, with Southeast Asia countries having a pooled incidence of 22%. Established risk factors include the severity of pain experienced during childbirth, analgesic techniques employed, and underlying psychological vulnerabilities.
Cesarean delivery, especially emergency Cesarean delivery, has been associated with an increased risk of PND. Childbirth often results in substantial tissue trauma, which may lead to persistent postpartum pain (PPP) that affects up to 20% of women globally. Both PND and PPP could contribute to a significant socioeconomic burden and diminished quality of life. Non-pharmacological interventions have demonstrated effectiveness in reducing depression and pain in postpartum women, as well as in populations with depression, and chronic pain. However, it remains uncertain whether delivering these interventions as part of a structured Collaborative Psychological Model (CPM) can effectively reduce the incidence of both PND and PPP. Currently, there is a lack of standardized and effective programs, with high risk PND stratification, addressing these outcomes in routine clinical care.
The proposed CPM in this study addresses these gaps through electronic surveys and mobile apps that enable mothers to manage their mental health without reliance on pharmacological therapy in a comfortable and private manner. By integrating multiple evidence-based interventions into a single program, we aim to leverage upon their individual efficacies and achieve a synergistic effect to improve outcomes related to PND and PPP.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ban Leong Sng, FFPMANZCA
- 전화번호: 65-6394-1077
- 이메일: sng.ban.leong@singhealth.com.sg
연구 연락처 백업
- 이름: Chin Wen Tan, PhD
- 전화번호: 65-6394 8436
- 이메일: Tan.Chin.Wen@kkh.com.sg
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria (Mothers):
- Healthy (American Society of Anesthesiologists (ASA) physical status II);
- Parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
- With a singleton fetus;
- Planning to have childbirth and delivery at study site;
- Patients with prior mental health history, and current active psychiatric care will also be recruited.
Inclusion Criteria (Fathers):
- Identified partner (e.g., husband or significant other) of the enrolled pregnant patient;
- Aged 21 years and above;
- Able to understand the study procedures and willing to participate in the 8 weeks postpartum assessment.
Exclusion Criteria (Mothers):
- History of intravenous drug or opioid abuse;
- Previous history of chronic pain syndrome.
Exclusion Criteria (Fathers):
- Unable to provide informed consent (e.g., cognitive impairment, language barriers without available translation support);
- Any condition that, in the opinion of the investigators, would make participation inappropriate (e.g., severe psychiatric or medical condition).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Collaborative Psychological Model (CPM) group
Patients are assigned to have mindfulness training through customised mobile app on psychological strategies, and music listening before discharge from hospital until week 8 postpartum.
Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10 (low risk of postnatal depression), or all patients of high risk of postnatal depression.
Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum.
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum.
|
Participants assigned to the interventional arm will receive the following psychological therapies:
Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum.
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum.
|
|
활성 비교기: Non- Collaborative Psychological Model (CPM) group
Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum.
Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10.
Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum.
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum.
|
Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum.
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum.
Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The incidence of postnatal depression in both groups
기간: 8 weeks after delivery (2 months)
|
Incidence of postnatal depression will be assessed via Edinburgh Postnatal Depression Scale (EPDS) score at week 8 postpartum.
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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
두 그룹의 모유수유 자기효능감
기간: 배송 후 8주(2개월)
|
모유수유 자기효능감은 모유수유 자기효능감 척도-단축형(BSES-SF)으로 평가됩니다.
모유수유 자기효능감은 아기에게 얼마나 잘 모유수유를 할 수 있는지에 대한 엄마의 자신감과 인식을 의미합니다.
14개 항목의 자가 관리형 BSES-SF는 5점 리커트 유형 척도로 제공되며 1은 전혀 자신이 없음을 나타내고 5는 항상 자신이 있음을 나타냅니다.
점수를 합산하면 14~70점 범위가 나오며, 점수가 높을수록 모유수유 자기효능감이 높음을 나타냅니다.
|
배송 후 8주(2개월)
|
|
두 그룹의 산후 결합
기간: 배송 후 8주(2개월)
|
산후 결합은 산후 결합 설문지(PBQ)로 평가됩니다.
4개의 하위 척도에 25개 항목으로 구성되어 있습니다. i) 결합 장애; ii) 거절과 분노; iii) 치료에 대한 불안; 및 iv) 남용의 위험.
항목은 0(항상)에서 5(절대 안함) 범위의 리커트 척도를 기반으로 하며 총 점수 범위는 0에서 125까지이며 PBQ 점수가 낮을수록 엄마와 아이의 유대감이 더 좋아집니다.
|
배송 후 8주(2개월)
|
|
두 그룹의 건강 상태
기간: 배송 후 8주(2개월)
|
건강 상태는 일반적인 건강 상태를 측정하기 위한 표준화된 도구인 EQ-5D-5L을 통해 평가됩니다.
두 가지 구성 요소로 구성됩니다. 건강 상태 설명 및 평가.
건강 상태는 5차원(5D)으로 측정됩니다. 이동성, 자가 관리, 일상 활동, 통증/불편, 불안/우울; 각 치수 범위는 1-5(5L)입니다.
이 다섯 가지 차원에서 EQ-5D 지수가 계산되며 값은 0-1 사이입니다.
평가 부분은 아날로그 척도를 사용하여 조사 당일 건강 상태를 20cm 수직 척도에 끝점을 0과 100으로 표시하도록 요청합니다.
0은 "상상할 수 있는 최악의 건강 상태"에 해당하고 100은 "상상할 수 있는 최상의 건강 상태"에 해당합니다.
|
배송 후 8주(2개월)
|
|
The incidence of persistent postpartum pain (PPP) in both groups
기간: 8 weeks after delivery (2 months)
|
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 postpartum.
|
8 weeks after delivery (2 months)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ban Leong Sng, FFPMANZCA, KK Women's and Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ECOS Ref 2026-1366
- CSASI25jul-0004 (기타 보조금/기금 번호: NMRC Clinician Scientist Award - Senior Investigator)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .