Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07772219
Status
Recruiting
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Conditions

  • Cesarean Delivery
  • Maternal Anxiety

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Jul 9, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
272 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Standard Forearm Restraint
    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.
  • Experimental: Wrist-Level Gripping Restraint
    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.

Primary Outcome Measure

Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6) [ Time Frame: Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University HospitalsColumbusOhio43201
Ling-Qun Hu, MD
[email protected]
614-293-8000
Ling-Qun Hu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Ohio State University Hospitals· Columbus, OH

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