A Pilot Feasibility Trial for an Intervention to Reduce Chronic Pain Following Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of participants registering for Empowered Relief session
研究概览
简要总结
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 18 years of age or older
- •Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth
- •has moderate/severe pain, scoring ≥ 4/10 on the numerical/visual analog scale that continues at 6 weeks postpartum
- •English fluency
- •Ability to adhere to and complete study protocols
- •Access to smart device for zoom / video meetings
排除标准
- •Chronic pain prior to pregnancy
- •Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
研究组 & 干预措施
1-Session pain relief skills session (Empowered Relief)
Participants will attend an Empowered Relief session at the beginning of the study period.
Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to patients by a certified instructor using a standardized treatment manual and slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.
Standard of care will be maintained for all participants, and supplemented with Empowered Relief. Pain management is not a factor for inclusion/exclusion criteria and patients will continue their pain management as prescribed and directed by their provider
干预措施: Empowered Relief (Behavioral)
Control arm: Postpartum Standard of Care
Participants will follow their current standard of care.
结局指标
主要结局
Percentage of participants registering for Empowered Relief session
时间窗: Baseline (up to 1 week)
Percentage of participants attending Empowered Relief session
时间窗: Treatment (up to 2 weeks)
Participant Satisfaction Scale Score
时间窗: 1 - 2 weeks Post treatment
Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).
Participant Treatment Skills Use Scale Score
时间窗: 4 - 6 weeks Post Treatment
Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).
次要结局
- Change from baseline in PROMIS Pain Interference 8a scale score(Baseline, Week 6)
- Change from baseline in PROMIS Pain Intensity 3a scale score(Baseline, Week 6)
- Change from baseline in Pain Catastrophizing Scale Score(Baseline, Week 6)
- Change from baseline in PEG scale score (composite)(From enrollment to the end of study completion at 6 weeks)
- Change from baseline in PEG scale score (pain interference)(From enrollment to the end of study completion at 6 weeks)
- Change from baseline in PEG scale score (pain intensity)(From enrollment to the end of study completion at 6 weeks)
- Response rate to individual items of the PEG scale score via SMS(From enrollment to the end of study completion at 6 weeks)
研究者
PSultan
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)
Stanford University