A Pilot Feasibility Trial for a Comprehensive Multimodal Intervention to Assess Global Recovery 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) and educational content on global postpartum recovery 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 woman scheduled for a cesarean delivery in the Stanford Healthcare system with a viable birth
- •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) and Education
Participants will view educational content online on postpartum care and attend a 2 hour Empowered Relief session at the beginning of the study period.
Standard of care will be maintained for all participants, and supplemented with Educational content and Empowered Relief.
干预措施: Empowered Relief (Behavioral)
1-Session pain relief skills session (Empowered Relief) and Education
Participants will view educational content online on postpartum care and attend a 2 hour Empowered Relief session at the beginning of the study period.
Standard of care will be maintained for all participants, and supplemented with Educational content and Empowered Relief.
干预措施: Education (Other)
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 2 weeks)
Percentage of participants attending Empowered Relief session
时间窗: Treatment (up to 2 weeks)
Empowered Relief: 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).
Empowered Relief: Participant Treatment Skills Use Scale Score
时间窗: Week 3, Week 8, Week 14
Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).
Percentage of participants watching educational content
时间窗: Treatment (up to 2 weeks), Week 3
Educational content: Participant Satisfaction Scale Score
时间窗: 1 - 2 weeks Post treatment, Week 3, Week 8, Week 14
Participant satisfaction will be measured using a 7 item questionnaire with three scored items: overall usefulness (0-6), the usefulness rating of each module (0-6), and frequency of use (0-3). The composite score ranges from 0-15, with higher scores indicating greater satisfaction and use. Additional checklist and free-text items capture engagement but are not included in the score.
次要结局
- Change from baseline in PROMIS Pain Interference 8a scale score(Baseline, Week 3, Week 8, Week 14)
- Change from baseline in PROMIS Pain Intensity 3a scale score(Baseline, Week 3, Week 8, Week 14)
- Change from baseline in Pain Catastrophizing Scale Score(Baseline, Week 3, Week 8, Week 14)
- Change from baseline in Pain Interference Scale Score via SMS(Baseline through end of study (up to 14 weeks))
- Response rate to Pain Interference scale score via SMS(Baseline through end of study (up to 14 weeks))
- Change from baseline in PROMIS Sleep Disturbance 8a scale score(Baseline, Week 3, Week 8, Week 14)
- Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score(Baseline, Week 2, Week 3, Week 8, Week 14)
研究者
Pervez Sultan
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)
Stanford University