Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery
14. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
272
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ling-Qun Hu, MD
- Telefonní číslo: 614-293-8000
- E-mail: LingQun.Hu@osumc.edu
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43201
- Nábor
- The Ohio State University Hospitals
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Kontakt:
- Ling-Qun Hu, MD
- Telefonní číslo: 614-293-8000
- E-mail: LingQun.Hu@osumc.edu
-
Vrchní vyšetřovatel:
- Ling-Qun Hu, MD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
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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.
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6)
Časové okno: 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.
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Preoperative holding area; after spinal/combined spinal-epidural placement; after skin incision; during skin closure; and 2 hours postoperatively in the PACU.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Patient Satisfaction
Časové okno: 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."
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Approximately 2 hours postoperatively in the PACU
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Patient Perception of Upper-Extremity Restraint Placement
Časové okno: Approximately 2 hours postoperatively in the PACU.
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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.
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Approximately 2 hours postoperatively in the PACU.
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Pain Assessed by Numeric Rating Scale (NRS)
Časové okno: Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
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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.
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Preoperative holding area; after skin incision prior to delivery; and 2 hours postoperatively in the PACU.
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Perioperative Heart Rate
Časové okno: At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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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.
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At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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Perioperative Blood Pressure
Časové okno: At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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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.
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At predefined perioperative assessment time points from the preoperative holding area through approximately 2 hours postoperatively in the post-anesthesia care unit (PACU).
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Postpartum Mood Assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Časové okno: Approximately 48 hours postoperatively.
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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.
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Approximately 48 hours postoperatively.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
9. července 2026
Primární dokončení (Odhadovaný)
31. prosince 2029
Dokončení studie (Odhadovaný)
31. prosince 2029
Termíny zápisu do studia
První předloženo
11. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
14. srpna 2026
První zveřejněno (Aktuální)
19. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- STUDY20260688
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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