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Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery
Sponsor: Ohio State University
Summary
This randomized controlled trial will compare two upper-extremity restraint techniques in patients undergoing elective cesarean delivery under neuraxial anesthesia. Participants will be randomly assigned to either standard forearm restraint placement or wrist-level gripping restraint placement. The study will evaluate whether the position of the restraint affects maternal anxiety during and after cesarean delivery. Anxiety will be measured at several perioperative time points using the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes include pain, patient satisfaction, physiological measures such as heart rate and blood pressure, postpartum distress and mood, and restraint-related safety events. The study aims to determine whether wrist-level gripping restraints may reduce anxiety and improve the patient experience compared with standard forearm restraints.
Official title: A Randomized Controlled Trial (RCT) Comparing Restrained vs Gripping String Techniques on Patients Undergoing Cesarean Delivery
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2026-07-09
Completion Date
2029-12-31
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
Standard Forearm Restraint
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.
Wrist-Level Gripping Restraint
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.
Locations (1)
The Ohio State University Hospitals
Columbus, Ohio, United States