Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
A Single-Session Pain Management Intervention for Severe Pain After Cesarean Delivery: A Pilot Feasibility Study
This pilot feasibility study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain management intervention, to postpartum patients experiencing severe pain following cesarean delivery during the inpatient period. Participants will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to receive either ER in addition to standard postpartum care or standard postpartum care alone. Participants will be followed for 12 weeks postpartum.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Severe acute pain following cesarean delivery may interfere with postpartum recovery and functioning. This pilot feasibility study will evaluate the feasibility of delivering Empowered Relief (ER) during the inpatient postpartum period to patients experiencing severe pain following cesarean delivery.
Eligible participants experiencing severe pain, defined as at least 2 numeric rating scale (NRS) pain scores >6/10 during the inpatient postpartum period, will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to an intervention or control group. Participants assigned to the intervention group will receive ER in addition to standard postpartum care. ER is a single 120-minute pain relief skills class that includes pain education, cognitive behavioral skills such as relaxation, deep breathing, and cognitive reframing, and development of a personalized plan. Participants will also receive access to a relaxation resource and weekly supportive text messages. Participants assigned to the control group will receive standard postpartum care alone.
The primary objective is to assess the feasibility of delivering the ER intervention during the inpatient postpartum period. Additional feasibility and acceptability outcomes include recruitment, registration and attendance at the ER session, treatment satisfaction, treatment skills use, adherence to study procedures, and participant retention. Pain-related patient-reported outcomes will also be explored over the 12-week follow-up period. Participants will complete follow-up assessments at 3, 6, and 12 weeks postpartum, with brief PEG pain assessments collected weekly through week 12.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Guillermina Ferrea, MD, MSc
- 전화번호: (650) 457-7704
- 이메일: gferrea@stanford.edu
연구 장소
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California
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Palo Alto, California, 미국, 94304
- Lucile Packard Children's Hospital Stanford
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연락하다:
- Guillermina Ferrea, MD, MSc
- 전화번호: (650) 457-7704
- 이메일: gferrea@stanford.edu
-
-
참여기준
자격 기준
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), provided the participant is clinically able to complete the study intervention and procedures.
- Currently hospitalized during the postpartum period following cesarean delivery.
- Severe pain, defined as at least 2 pain scores >6/10 on the numeric rating scale (NRS), following cesarean delivery.
- 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.
- Medical or clinical instability that, in the judgment of the treating or research team, would preclude safe participation in the study procedures and/or intervention.
- Chronic pain prior to pregnancy.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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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). |
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간섭 없음: Standard Postpartum Care
Participants randomized to the control group will receive standard postpartum care alone. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
기간: Day 1 ± 5 days, during the inpatient postpartum period
|
The proportion of participants randomized to the ER intervention arm who complete the 120-minute Empowered Relief (ER) session during the inpatient postpartum period. The proportion will be calculated as the number of participants who complete the ER session divided by the total number of participants randomized to the ER intervention arm. |
Day 1 ± 5 days, during the inpatient postpartum period
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
기간: At screening
|
The proportion of screened patients who meet all study eligibility criteria. The proportion will be calculated as the number of screened patients who are eligible for the study divided by the total number of patients screened. |
At screening
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Proportion of eligible patients that consent to study from those approached
기간: Baseline (Day 1)
|
The proportion of eligible patients approached for study participation who provide informed consent. The proportion will be calculated as the number of eligible patients who provide informed consent divided by the total number of eligible patients approached for participation. |
Baseline (Day 1)
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Proportion of recruited patients randomized to the ER intervention arm who register for the ER session
기간: Day 1 ± 5 days, during the inpatient postpartum period
|
The proportion of participants randomized to the ER intervention arm who register for the Empowered Relief (ER) session. The proportion will be calculated as the number of participants who register for the ER session divided by the total number of participants randomized to the ER intervention arm. |
Day 1 ± 5 days, during the inpatient postpartum period
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Proportion of recruited patients randomized to the ER intervention arm who attend the ER session
기간: Day 1 ± 5 days, during the inpatient postpartum period
|
The proportion of participants randomized to the ER intervention arm who attend the Empowered Relief (ER) session during the inpatient period. The proportion will be calculated as the number of participants who attend the ER session divided by the total number of participants randomized to the ER intervention arm. |
Day 1 ± 5 days, during the inpatient postpartum period
|
|
Treatment Appraisal score (intervention arm)
기간: Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
|
Treatment satisfaction among participants in the ER intervention arm will be assessed using the 7-item Treatment Appraisal scale. Total scores range from 0 to 42, with higher scores indicating greater satisfaction with the intervention. Additional quantitative and categorical items included in the questionnaire are not included in the total score and will be summarized separately. |
Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
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Qualitative feedback regarding the ER intervention (intervention arm)
기간: Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
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Qualitative feedback regarding the Empowered Relief (ER) intervention will be collected from participants in the ER intervention arm through optional free-text responses. This outcome does not generate a numerical score or scale value. |
Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
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Participant Treatment Skills Use Scale score (intervention arm)
기간: Week 3; week 6; week 12
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Use of skills taught during the Empowered Relief (ER) intervention will be assessed among participants in the ER intervention arm using the 5-item Participant Treatment Skills Use Scale. Total scores range from 5 to 25, with higher scores indicating greater use of the skills. |
Week 3; week 6; week 12
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Adherence to study procedures: Completion rate of scheduled surveys
기간: From enrollment through end-of-study (12-week follow-up)
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The percentage of scheduled study surveys completed by enrolled participants. |
From enrollment through end-of-study (12-week follow-up)
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Adherence to study procedures: Completion rate of scheduled repeated Pain, Enjoyment, General Activity (PEG) assessments
기간: Weekly from enrollment through end-of-study (12-week follow-up)
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The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants. |
Weekly from enrollment through end-of-study (12-week follow-up)
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Adherence to study procedures: Participant retention through end-of-study follow-up
기간: From enrollment through end-of-study (12-week follow-up)
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The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment. |
From enrollment through end-of-study (12-week follow-up)
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 88454
- 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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