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Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

2026年8月14日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

272

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Ohio
      • Columbus、Ohio、アメリカ、43201
        • 募集
        • The Ohio State University Hospitals
        • コンタクト：
        • 主任研究者：
          • Ling-Qun Hu, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
他の：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.
実験的：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Maternal Anxiety Assessed by the State-Trait Anxiety Inventory-6 (STAI-6)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Patient Satisfaction
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ohio State University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月9日

一次修了 (推定)

2029年12月31日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月14日

最初の投稿 (実際)

2026年8月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • STUDY20260688

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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いいえ

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いいえ

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