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Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

14 agosto 2026 aggiornato da: Ohio State University

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

272

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43201
        • Reclutamento
        • The Ohio State University Hospitals
        • Contatto:
        • Investigatore principale:
          • Ling-Qun Hu, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6)
Lasso di tempo: Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Patient Satisfaction
Lasso di tempo: Approximately 2 hours postoperatively in the PACU
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."
Approximately 2 hours postoperatively in the PACU
Patient Perception of Upper-Extremity Restraint Placement
Lasso di tempo: Approximately 2 hours postoperatively in the PACU.
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.
Approximately 2 hours postoperatively in the PACU.
Pain Assessed by Numeric Rating Scale (NRS)
Lasso di tempo: Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
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.
Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
Perioperative Heart Rate
Lasso di tempo: At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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.
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
Lasso di tempo: At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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.
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)
Lasso di tempo: Approximately 48 hours postoperatively.
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.
Approximately 48 hours postoperatively.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ohio State University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 luglio 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 agosto 2026

Primo Inserito (Effettivo)

19 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • STUDY20260688

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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