Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years to 50 years old
Singleton pregnancy
Term gestation (≥37 weeks)
Spinal or combined spinal-epidural anesthesia planned
Disqualifiers
Not receiving neuraxial anesthesia or not scheduled for cesarean delivery
Preeclampsia
Documented fetal anomaly/congenital malformations
Intrauterine growth restriction (IUGR)
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Forearm Restraint
Other interventionA 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.
Wrist-Level Gripping Restraint
Other interventionA 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.
Treatment groups
272 Participants
are divided into 2 treatment groupsGroup A: Standard Forearm RestraintActive comparator 1 intervention
Group B: Wrist-Level Gripping RestraintExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6)
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.
Time frame
Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU.Secondary outcomes
1
Overall Patient Satisfaction
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."
Time frame
Approximately 2 hours postoperatively in the PACU2
Patient Perception of Upper-Extremity Restraint Placement
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.
Time frame
Approximately 2 hours postoperatively in the PACU.3
Pain Assessed by Numeric Rating Scale (NRS)
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.
Time frame
Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.4
Perioperative Heart Rate
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.
Time frame
At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).Sponsors and contacts
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Source ClinicalTrials.gov