Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years to 50 years old

Singleton pregnancy

Term gestation (≥37 weeks)

Spinal or combined spinal-epidural anesthesia planned

Disqualifiers

Not receiving neuraxial anesthesia or not scheduled for cesarean delivery

Preeclampsia

Documented fetal anomaly/congenital malformations

Intrauterine growth restriction (IUGR)

Trial design

Treatments tested in this trial

  • Standard Forearm Restraint
  • Wrist-Level Gripping Restraint

Treatment groups

272 Participants
are divided into 2 treatment groups

Sponsors and collaborators