Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

Purpose

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.

Conditions

  • Maternal Anxiety
  • Cesarean Delivery

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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 to suturing

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Other: 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.
Experimental
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.
  • Other: 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.

Recruiting Locations

The Ohio State University Hospitals
Columbus, Ohio 43201
Contact:
Ling-Qun Hu, MD
614-293-8000
LingQun.Hu@osumc.edu

More Details

Status
Recruiting
Sponsor
Ohio State University

Study Contact

Ling-Qun Hu, MD
614-293-8000
LingQun.Hu@osumc.edu

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.