Recruiting

Forearm vs. Gripping

Sponsor:

Ohio State University

Code:

NCT07772219

Conditions

Maternal Anxiety

Cesarean Delivery

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Forearm Restraint

Wrist-Level Gripping Restraint

Study Details

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

Study ID

NCT07772219

Start date

Jul 9, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

272 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Standard 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.

Wrist-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.

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 and Locations

Central contacts

Ling-Qun Hu, MD

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

Locations

The Ohio State University Hospitals

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Ling-Qun Hu, MD

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

Principal Investigator:

Ling-Qun Hu, MD

More Information

Sponsor

Ohio State University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-08-19.