A Randomized Controlled Trial (RCT) Comparing Restrained vs Gripping String Techniques on Patients Undergoing Cesarean Delivery
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.
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.…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- OtherStandard 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.
- OtherWrist-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.
Location
- The Ohio State University HospitalsColumbus, Ohio