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Reducing Chronic Pain Following Cesarean Delivery

2026年10月27日 更新者：Pervez Sultan、Stanford University

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

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。

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94304
        • 招聘中
        • Stanford Medicine Children's Health - Specialty Services, Welch Road
        • 首席研究员：
          • Pervez Sultan, MD
        • 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).
  6. All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
  7. Attend the 6-week postpartum clinic visit.
  8. Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
  9. English fluency, with ability to read and write.
  10. Ability to adhere to and complete study procedures.
  11. Access to a smart device if attending ER session via Zoom.

Exclusion Criteria:

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

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：不适用
  • 介入模型：单组作业
  • 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).

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 patients that complete the Empowered Relief session
大体时间：Within 2 weeks of enrollment

The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.
Within 2 weeks of enrollment

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：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
Proportion of eligible patients that consent to study from those approached
大体时间：During screening and enrollment, at approximately 6 weeks postpartum

The proportion of eligible patients who provide informed consent and enroll in the study.
During screening and enrollment, at approximately 6 weeks postpartum
Proportion of recruited patients who register for the Empowered Relief session
大体时间：Within 1 week of enrollment

The proportion of recruited patients who register for the Empowered Relief session.
Within 1 week of enrollment
Proportion of recruited patients who attend the Empowered Relief session
大体时间：Within 2 weeks of baseline

The proportion of recruited patients who attend an Empowered Relief session.
Within 2 weeks of baseline
Treatment Appraisal score
大体时间：Immediately after the Empowered Relief session, up to 2 weeks post-treatment

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
Qualitative feedback regarding the Empowered Relief intervention
大体时间：Immediately after the Empowered Relief session, up to 2 weeks post-treatment

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
Participant Treatment Skills Use Scale score
大体时间：Weekly from completion of the Empowered Relief session through 12 weeks postpartum

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
Adherence to Study Procedures: completion rate of scheduled surveys
大体时间：From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum

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
Adherence to study procedures: completion rate of scheduled PEG assessments
大体时间：From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum

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
Adherence to study procedures: proportion of participants retained through end-of-study follow-up
大体时间：From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum

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

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)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (实际的)

2026年10月26日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年3月14日

研究注册日期

首次提交

2026年8月28日

首先提交符合 QC 标准的

2026年8月28日

首次发布 (实际的)

2026年9月2日

研究记录更新

最后更新发布 (实际的)

2026年10月28日

上次提交的符合 QC 标准的更新

2026年10月27日

最后验证

2026年10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

  • 84718
  • 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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