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Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period

2026年9月29日 更新者：Pervez Sultan、Stanford University

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94304
        • Lucile Packard Children's Hospital Stanford
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  1. Complete informed consent.
  2. Age 18 years or above.
  3. Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
  4. Viable birth (singleton or multiple gestation).
  5. 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.
  6. Currently hospitalized during the postpartum period following cesarean delivery.
  7. Severe pain, defined as at least 2 pain scores >6/10 on the numeric rating scale (NRS), following cesarean delivery.
  8. English fluency, with ability to read and write.
  9. Ability to adhere to and complete study procedures.
  10. Access to a smart device if attending ER session via Zoom.

Exclusion Criteria:

  1. Age under 18 years.
  2. 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.
  3. Chronic pain prior to pregnancy.
  4. Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
  5. Unable or unwilling to provide informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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).
行为的：Empowered Relief

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).
无干预：Standard Postpartum Care

Participants randomized to the control group will receive standard postpartum care alone.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Proportion of screened patients who are eligible for the study
大体时间：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
Proportion of eligible patients that consent to study from those approached
大体时间：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)
Proportion of recruited patients randomized to the ER intervention arm who register for the ER session
大体时间：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
Proportion of recruited patients randomized to the ER intervention arm who attend the ER session
大体时间：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)
大体时间：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)
Qualitative feedback regarding the ER intervention (intervention arm)
大体时间：Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)

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)
Participant Treatment Skills Use Scale score (intervention arm)
大体时间：Week 3; week 6; week 12

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
Adherence to study procedures: Completion rate of scheduled surveys
大体时间：From enrollment through end-of-study (12-week follow-up)

The percentage of scheduled study surveys completed by enrolled participants.
From enrollment through end-of-study (12-week follow-up)
Adherence to study procedures: Completion rate of scheduled repeated Pain, Enjoyment, General Activity (PEG) assessments
大体时间：Weekly from enrollment through end-of-study (12-week follow-up)

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)
Adherence to study procedures: Participant retention through end-of-study follow-up
大体时间：From enrollment through end-of-study (12-week follow-up)

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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

合作者

National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月5日

初级完成 (估计的)

2027年1月15日

研究完成 (估计的)

2027年4月9日

研究注册日期

首次提交

2026年9月11日

首先提交符合 QC 标准的

2026年9月16日

首次发布 (实际的)

2026年9月21日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 88454
  • K24DA053564 (美国 NIH 拨款/合同)
  • R90HD118650 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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