Maternal AnxietyNCT07772219
Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery
A study testing Standard Forearm Restraint and Wrist-Level Gripping Restraint in people with Maternal Anxiety and Cesarean Delivery, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Anxiety, Cesarean Delivery
- What is being tested?
- Standard Forearm Restraint and Wrist-Level Gripping Restraint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Hospitals
Columbus, Ohio, 43201
Ling-Qun Hu, MD, 614-293-8000, LingQun.Hu@osumc.edu
Ling-Qun Hu, MD
About this study
Official title: A Randomized Controlled Trial (RCT) Comparing Restrained vs Gripping String Techniques on Patients Undergoing Cesarean Delivery
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.
Read the 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.
- Conditions
- Maternal Anxiety, Cesarean Delivery
- Being tested
- Standard Forearm Restraint, Wrist-Level Gripping Restraint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Forearm RestraintOther
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 RestraintOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Wrist-Level Gripping Restraint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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."
Measured: Approximately 2 hours postoperatively in the PACU
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.
Measured: Approximately 2 hours postoperatively in the PACU.
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.
Measured: Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
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.
Measured: 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
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.
Measured: At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
Postpartum Mood Assessed by the Edinburgh Postnatal Depression Scale (EPDS)
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.
Measured: Approximately 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start9 Jul 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AnxietyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772219
- Sponsor's protocol ID
- STUDY20260688
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared with outside researchers. Study data will be maintained securely within The Ohio State University Wexner Medical Center and accessed only by authorized study personnel. Any future external sharing of study data would require appropriate IRB approval and would occur only in coded or de-identified form in accordance with institutional and federal requirements.