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Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

RECRUITINGN/ASponsored by Ohio State University
Actively Recruiting
PhaseN/A
SponsorOhio State University
Started2026-07-09
Est. completion2029-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

AnxietyCesarean DeliveryMaternal Anxiety

Locations1 site

The Ohio State University Hospitals
Columbus, Ohio, 43201
Ling-Qun Hu, MD614-293-8000LingQun.Hu@osumc.edu

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