A Single-Session Pain Management Intervention for Severe Pain After Cesarean Delivery: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
研究概览
简要总结
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.
详细描述
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 more than 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
盲法说明
Because the behavioral intervention cannot be masked, the study is open-label. All outcomes are participant-reported.
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
- •Complete informed consent.
- •Age 18 years or above.
- •Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
- •Viable birth (singleton or multiple gestation).
- •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.
- •Currently hospitalized during the postpartum period following cesarean delivery.
- •Severe pain, defined as more than 2 pain scores >6/10 on the numeric rating scale (NRS), following cesarean delivery.
- •English fluency, with ability to read and write.
- •Ability to adhere to and complete study procedures.
- •Access to a smart device if attending ER session via Zoom.
排除标准
- •Age under 18 years.
- •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.
- •Chronic pain prior to pregnancy.
- •Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- •Unable or unwilling to provide informed consent.
研究组 & 干预措施
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).
干预措施: Empowered Relief (Behavioral)
Standard Postpartum Care
Participants randomized to the control group will receive standard postpartum care alone.
结局指标
主要结局
Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
时间窗: 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.
次要结局
- Proportion of screened patients who are eligible for the study(At screening)
- Proportion of eligible patients that consent to study from those approached(Baseline (Day 1))
- Proportion of recruited patients randomized to the ER intervention arm who register for the ER session(Day 1 ± 5 days, during the inpatient postpartum period)
- Proportion of recruited patients randomized to the ER intervention arm who attend the ER session(Day 1 ± 5 days, during the inpatient postpartum period)
- Treatment Appraisal score (intervention arm)(Immediately post-intervention or within a defined short window after ER (Day 1 ± 7))
- Qualitative feedback regarding the ER intervention (intervention arm)(Immediately post-intervention or within a defined short window after ER (Day 1 ± 7))
- Participant Treatment Skills Use Scale score (intervention arm)(Week 3; week 6; week 12)
- Adherence to study procedures: Completion rate of scheduled surveys(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(Weekly from enrollment through end-of-study (12-week follow-up))
- Adherence to study procedures: Participant retention through end-of-study follow-up(From enrollment through end-of-study (12-week follow-up))
研究者
Pervez Sultan
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)
Stanford University