Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

NCT07772219 | Recruiting DMC

• 1 other identifier: STUDY20260688
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Anxiety; Cesarean Delivery

Outcome Measures

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.

  Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU.

Secondary Outcomes (6)

• Overall Patient Satisfaction

  Approximately 2 hours postoperatively in the PACU

• Patient Perception of Upper-Extremity Restraint Placement

  Approximately 2 hours postoperatively in the PACU.

• Pain Assessed by Numeric Rating Scale (NRS)

  Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.

• 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).

• 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).

Study Arms (2)

Standard Forearm Restraint

ACTIVE COMPARATOR

Participants assigned to the control arm will receive the standard institutional forearm restraint during cesarean delivery. A soft padded restraint will be secured around the mid-forearm and attached to the arm board to limit excessive movement while allowing the patient's hand to remain free.

Other: Standard Forearm Restraint

Wrist-Level Gripping Restraint

EXPERIMENTAL

Participants assigned to the intervention arm will receive a wrist-level gripping restraint during cesarean delivery. A soft string restraint will be positioned at the wrist, allowing the participant to comfortably maintain a gentle closed-hand gripping position while stabilizing the upper extremity and maintaining the sterile operative field.

Other: Wrist-Level Gripping Restraint

Interventions

Standard Forearm Restraint OTHER

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.

Standard Forearm Restraint

Wrist-Level Gripping Restraint OTHER

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.

Wrist-Level Gripping Restraint

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Hospitals

Columbus, Ohio, 43201, United States

RECRUITING

Central Study Contacts

Ling-Qun Hu, MD

CONTACT

614-293-8000; LingQun.Hu@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)