Restrained vs Gripping Wrist Restraints for Cesarean Delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center trial compares two upper-extremity restraint configurations during elective cesarean delivery under neuraxial anesthesia. Participants are assigned to either standard forearm restraints or wrist-level gripping restraints, with care taken to maintain safety and comfort. Anxiety will be measured at multiple perioperative time points using the STAI-6, and secondary outcomes include pain, satisfaction, vital signs, mood after delivery, and any restraint-related safety events. The aim is to determine if the wrist-level restraint improves the perioperative experience compared with the forearm restraint. The study is conducted at The Ohio State University Wexner Medical Center, with a 1:1 randomization and standardized procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• The Ohio State University Hospitals
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Ling-Qun Hu, MD
• Email: LingQun.Hu@osumc.edu
• Phone: 614-293-8000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.