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Sponsor: Ohio State University
Conditions: Maternal Anxiety, Cesarean Delivery
Interventions: Standard Forearm Restraint, Wrist-Level Gripping Restraint
Countries: United States
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.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Columbus, Ohio, United States