Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

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.

Detailed Description

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.

Eligibility Criteria

Interventions