Reducing Chronic Pain Following Cesarean Delivery
A Pilot Feasibility Study of an Intervention to Reduce Chronic Pain Following Cesarean Delivery
This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and/or pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Palo Alto, California, 미국, 94304
- 모병
- Stanford Medicine Children's Health - Specialty Services, Welch Road
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수석 연구원:
- Pervez Sultan, MD
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연락하다:
- Pervez Sultan, MD
- 전화번호: (669) 800 9929
- 이메일: psultan@stanford.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Complete informed consent.
- Age 18 years or above.
- Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
- Viable birth (singleton or multiple gestation).
- All maternal demographics and complications are eligible: parity, medical conditions (e.g., pre-eclampsia, gestational diabetes), and post-surgical complications (e.g., hysterectomy, ICU admission, extended hospital stay).
- All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
- Attend the 6-week postpartum clinic visit.
- Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
- English fluency, with ability to read and write.
- Ability to adhere to and complete study procedures.
- Access to a smart device if attending ER session via Zoom.
Exclusion Criteria:
- Age under 18 years.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
- Chronic pain prior to pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Empowered Relief
Participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. The session includes pain education and cognitive-behavioral pain management skills, including relaxation, deep breathing, reframing, and development of a personalized plan. Participants will also receive access to a smartphone relaxation resource (Calm Tool app, or a relaxation audio file if the app cannot be downloaded). |
A single 120-minute pain relief skills class delivered by trained, certified instructors via Zoom or in person. The session includes pain education, cognitive behavioral skills including relaxation, deep breathing, and reframing, and completion of a personalized plan. Following the session, participants receive access to the Calm Tool smartphone relaxation app (or a binaural relaxation audio file if the app cannot be downloaded). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of enrolled patients that complete the Empowered Relief session
기간: Within 2 weeks of enrollment
|
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session. |
Within 2 weeks of enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
기간: During screening, at approximately 6 weeks postpartum
|
The proportion of screened patients that meet the study eligibility criteria. |
During screening, at approximately 6 weeks postpartum
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Proportion of eligible patients that consent to study from those approached
기간: During screening and enrollment, at approximately 6 weeks postpartum
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The proportion of eligible patients who provide informed consent and enroll in the study. |
During screening and enrollment, at approximately 6 weeks postpartum
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|
Proportion of recruited patients who register for the Empowered Relief session
기간: Within 1 week of enrollment
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The proportion of recruited patients who register for the Empowered Relief session. |
Within 1 week of enrollment
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Proportion of recruited patients who attend the Empowered Relief session
기간: Within 2 weeks of baseline
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The proportion of recruited patients who attend an Empowered Relief session. |
Within 2 weeks of baseline
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Treatment Appraisal score
기간: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention |
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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Qualitative feedback regarding the Empowered Relief intervention
기간: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire. |
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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Participant Treatment Skills Use Scale score
기간: Weekly from completion of the Empowered Relief session through 12 weeks postpartum
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Use of skills learned during the Empowered Relief intervention assessed using the 5-item Participant Treatment Skills Use Scale. Total scores range from 0 to 25, with higher scores indicating greater use of treatment skills. |
Weekly from completion of the Empowered Relief session through 12 weeks postpartum
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Adherence to Study Procedures: completion rate of scheduled surveys
기간: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
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The percentage of scheduled study surveys completed by enrolled participants. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
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Adherence to study procedures: completion rate of scheduled PEG assessments
기간: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
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The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
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Adherence to study procedures: proportion of participants retained through end-of-study follow-up
기간: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
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The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 84718
- K24DA053564 (미국 NIH 보조금/계약)
- R90HD118650 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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