Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery
A Randomized Controlled Trial (RCT) Comparing Restrained vs Gripping String Techniques on Patients Undergoing Cesarean Delivery
研究概览
详细说明
This is a prospective, single-center, double-blinded randomized controlled trial evaluating two upper-extremity restraint configurations during elective cesarean delivery under neuraxial anesthesia at The Ohio State University Wexner Medical Center. The study is designed to determine whether changing restraint placement from the standard forearm position to a wrist-level gripping position influences the perioperative experience, particularly maternal anxiety.
After written informed consent is obtained, participants will be randomized in a 1:1 ratio using a secure REDCap randomization module. Participants assigned to the control group will receive the institution's standard soft forearm restraint. Participants assigned to the intervention group will receive a soft string restraint positioned at the wrist that allows the hand to remain in a gentle gripping position. The restraints will be applied according to standardized procedures and may be adjusted if discomfort or safety concerns arise. No drugs, biologics, or investigational devices are administered as part of the study intervention.
Study assessments will occur at predefined perioperative time points from the preoperative period through approximately 48 hours after delivery. Patient-reported measures will be collected by trained research staff, and relevant demographic, clinical, and physiologic information will be obtained from the electronic medical record. Study data and randomization assignments will be maintained in REDCap. Participant involvement will end after the approximately 48-hour postoperative assessments, with no planned long-term follow-up.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ling-Qun Hu, MD
- 电话号码:614-293-8000
- 邮箱:LingQun.Hu@osumc.edu
学习地点
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Ohio
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Columbus、Ohio、美国、43201
- 招聘中
- The Ohio State University Hospitals
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接触:
- Ling-Qun Hu, MD
- 电话号码:614-293-8000
- 邮箱:LingQun.Hu@osumc.edu
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首席研究员:
- Ling-Qun Hu, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years to 50 years old
- Singleton pregnancy
- Term gestation (≥37 weeks)
- Spinal or combined spinal-epidural anesthesia planned
- Scheduled for elective cesarean delivery
- Ability to provide informed consent in English
Exclusion Criteria:
- Not receiving neuraxial anesthesia or not scheduled for cesarean delivery
- Preeclampsia
- Documented fetal anomaly/congenital malformations
- Intrauterine growth restriction (IUGR)
- Unable to provide informed consent in English without interpreting services or personnel
- Prisoners
- Elects for skin-to-skin contact prior to suturing
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Standard Forearm Restraint
Participants assigned to the control arm will receive the standard institutional forearm restraint during cesarean delivery.
A soft padded restraint will be secured around the mid-forearm and attached to the arm board to limit excessive movement while allowing the patient's hand to remain free.
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A soft padded restraint is secured circumferentially around the participant's mid-forearm and attached to the arm board during cesarean delivery.
This is the current institutional standard of care and is intended to stabilize the arm and limit excessive movement while leaving the hand free.
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实验性的:Wrist-Level Gripping Restraint
Participants assigned to the intervention arm will receive a wrist-level gripping restraint during cesarean delivery.
A soft string restraint will be positioned at the wrist, allowing the participant to comfortably maintain a gentle closed-hand gripping position while stabilizing the upper extremity and maintaining the sterile operative field.
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A soft string restraint is positioned at the participant's wrist during cesarean delivery, allowing the participant to comfortably grasp the restraint in a closed-hand position.
The technique stabilizes the upper extremity while permitting continuous hand gripping and maintaining the sterile operative field.
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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 |
|---|---|---|
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Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6)
大体时间:Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU.
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Maternal anxiety will be assessed using the 6-item State-Trait Anxiety Inventory (STAI-6).
Scores range from 20 to 80, with higher scores indicating greater anxiety.
STAI-6 scores will be compared between the wrist-level gripping restraint group and the standard forearm restraint group.
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Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Patient Satisfaction
大体时间:Approximately 2 hours postoperatively in the PACU
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Participants will rate their overall satisfaction with the cesarean delivery procedure on a 0-100% scale, where 0% indicates "not satisfied at all" and 100% indicates "completely satisfied."
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Approximately 2 hours postoperatively in the PACU
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Patient Perception of Upper-Extremity Restraint Placement
大体时间:Approximately 2 hours postoperatively in the PACU.
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Participants will provide feedback regarding comfort and satisfaction with the positioning of their arms/hands during cesarean delivery using a Likert-scale assessment and an opportunity to provide additional qualitative comments.
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Approximately 2 hours postoperatively in the PACU.
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Pain Assessed by Numeric Rating Scale (NRS)
大体时间:Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
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Pain will be assessed using a Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain intensity.
Scores will be compared between the two restraint groups.
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Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
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Perioperative Heart Rate
大体时间:At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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Heart rate will be recorded to evaluate whether restraint configuration affects the perioperative physiological stress response.
Heart rate will be measured in beats per minute and compared between the two restraint groups.
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At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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Perioperative Blood Pressure
大体时间:At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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Blood pressure will be recorded to evaluate whether restraint configuration affects the perioperative physiological stress response.
Blood pressure will be measured in millimeters of mercury and compared between the two restraint groups.
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At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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Postpartum Mood Assessed by the Edinburgh Postnatal Depression Scale (EPDS)
大体时间:Approximately 48 hours postoperatively.
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Postpartum depressive symptoms will be assessed using the 10-item Edinburgh Postnatal Depression Scale (EPDS), with total scores ranging from 0 to 30.
Higher scores indicate greater postpartum depressive symptom severity.
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Approximately 48 hours postoperatively.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY20260688
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
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