Cesarean Delivery, Maternal Anxiety
Conditions
Brief 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.
Detailed description
This is a prospective, single-center, double-blinded randomized controlled trial evaluating two upper-extremity restraint configurations during elective cesarean delivery under neuraxial anesthesia at The Ohio State University Wexner Medical Center. The study is designed to determine whether changing restraint placement from the standard forearm position to a wrist-level gripping position influences the perioperative experience, particularly maternal anxiety. After written informed consent is obtained, participants will be randomized in a 1:1 ratio using a secure REDCap randomization module. Participants assigned to the control group will receive the institution's standard soft forearm restraint. Participants assigned to the intervention group will receive a soft string restraint positioned at the wrist that allows the hand to remain in a gentle gripping position. The restraints will be applied according to standardized procedures and may be adjusted if discomfort or safety concerns arise. No drugs, biologics, or investigational devices are administered as part of the study intervention. Study assessments will occur at predefined perioperative time points from the preoperative period through approximately 48 hours after delivery. Patient-reported measures will be collected by trained research staff, and relevant demographic, clinical, and physiologic information will be obtained from the electronic medical record. Study data and randomization assignments will be maintained in REDCap. Participant involvement will end after the approximately 48-hour postoperative assessments, with no planned long-term follow-up.
Interventions
OTHERStandard Forearm Restraint
A soft padded restraint is secured circumferentially around the participant's mid-forearm and attached to the arm board during cesarean delivery. This is the current institutional standard of care and is intended to stabilize the arm and limit excessive movement while leaving the hand free.
OTHERWrist-Level Gripping Restraint
A soft string restraint is positioned at the participant's wrist during cesarean delivery, allowing the participant to comfortably grasp the restraint in a closed-hand position. The technique stabilizes the upper extremity while permitting continuous hand gripping and maintaining the sterile operative field.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6) | Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU. | Maternal anxiety will be assessed using the 6-item State-Trait Anxiety Inventory (STAI-6). Scores range from 20 to 80, with higher scores indicating greater anxiety. STAI-6 scores will be compared between the wrist-level gripping restraint group and the standard forearm restraint group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Patient Satisfaction | Approximately 2 hours postoperatively in the PACU | Participants will rate their overall satisfaction with the cesarean delivery procedure on a 0-100% scale, where 0% indicates "not satisfied at all" and 100% indicates "completely satisfied." |
| Patient Perception of Upper-Extremity Restraint Placement | Approximately 2 hours postoperatively in the PACU. | Participants will provide feedback regarding comfort and satisfaction with the positioning of their arms/hands during cesarean delivery using a Likert-scale assessment and an opportunity to provide additional qualitative comments. |
| Pain Assessed by Numeric Rating Scale (NRS) | Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU. | Pain will be assessed using a Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain intensity. Scores will be compared between the two restraint groups. |
| Perioperative Heart Rate | At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU). | Heart rate will be recorded to evaluate whether restraint configuration affects the perioperative physiological stress response. Heart rate will be measured in beats per minute and compared between the two restraint groups. |
| Perioperative Blood Pressure | At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU). | Blood pressure will be recorded to evaluate whether restraint configuration affects the perioperative physiological stress response. Blood pressure will be measured in millimeters of mercury and compared between the two restraint groups. |
| Postpartum Mood Assessed by the Edinburgh Postnatal Depression Scale (EPDS) | Approximately 48 hours postoperatively. | Postpartum depressive symptoms will be assessed using the 10-item Edinburgh Postnatal Depression Scale (EPDS), with total scores ranging from 0 to 30. Higher scores indicate greater postpartum depressive symptom severity. |
Countries
United States
Contacts
CONTACTLing-Qun Hu, MD
Outcome results
None listed