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
- 80
- 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.
详细描述
study design was amended
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: Education (Other)
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)
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 4 weeks)
Percentage of participants attending Empowered Relief session
时间窗: Treatment (up to 4 weeks)
Empowered Relief: Participant Satisfaction Scale Score
时间窗: Week 1- 4 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 5, Week 10, Week 16
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 4 weeks)
Percentage of participants watching educational content post delivery
时间窗: Week 5 - 16
Educational content: Participant Satisfaction Scale Score
时间窗: Week 1- 4 Post treatment, Week 5, Week 10, Week 16
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 5, Week 10, Week 16)
- Change from baseline in PROMIS Pain Intensity 3a scale score(Baseline, Week 5, Week 10, Week 16)
- Change from baseline in Pain Catastrophizing Scale Score(Baseline, Week 5, Week 10, Week 16)
- Change from baseline in PROMIS Sleep Disturbance 8a scale score(Baseline, Week 5, Week 10, Week 16)
- Change from baseline in Pain Interference Scale Score via SMS(Baseline through end of study (up to 16 weeks))
- Response rate to Pain Interference scale score via SMS(Baseline through end of study (up to 16 weeks))
- Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score(Week 5, Week 10, Week 16)
研究者
Pervez Sultan
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)
Stanford University