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Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

RecruitingNAAges 18 Years - anyFemaleOhio State University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years to 50 years old * Singleton pregnancy * Term gestation (โ‰ฅ37 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
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What it tests

  • Standard Forearm Restraint
  • Wrist-Level Gripping Restraint
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Where

1 site
The Ohio State University Hospitals
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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