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RECRUITING Not applicable ClinicalTrials.gov

Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

Sponsor: Ohio State University • ClinicalTrials.gov ID: NCT07772219

Registry updated: 2026-08-19
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Description

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.

Interventions

  • Standard Forearm Restraint (Other)
    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 (Other)
    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.

Eligibility criteria

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

Conditions

Maternal Anxiety Cesarean Delivery

Locations

  • The Ohio State University Hospitals — Columbus, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record