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Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
272 (estimated)
Sponsor
Ohio State University · Other
Who this trial is looking for
This trial is looking for women who are having a cesarean delivery and want to help compare two different ways of securing their arms during surgery. Participants will be randomly assigned to one of the two techniques and will provide feedback about their anxiety and comfort during the procedure.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 50 years old
I am pregnant with a single baby
I am at least 37 weeks pregnant
I will be receiving spinal anesthesia for my surgery
I am scheduled for an elective cesarean delivery
I can give informed consent in English
You may not be able to join if
I am not scheduled for a cesarean delivery
I have preeclampsia
I have a documented fetal anomaly or congenital malformation
My baby has intrauterine growth restriction (IUGR)
I cannot provide informed consent in English without help
I am a prisoner
I want skin-to-skin contact before suturing
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 …
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
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