Video Versus Verbal Preoperative Education in Elective Cesarean Delivery (VIDEO-CS)
Effects of Verbal and Video-Based Preoperative Education on Anxiety and Serum Cortisol Response in Women Scheduled for Elective Cesarean Delivery: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial aims to evaluate the effects of verbal and video-based preoperative education on anxiety levels and serum cortisol response in women scheduled for elective cesarean delivery under spinal anesthesia.
Eligible participants will be randomly assigned to receive either standard verbal education or a standardized video-based educational intervention before surgery. Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI-S), and serum cortisol levels will be measured before and after the educational intervention.
The primary objective is to compare the effectiveness of the two educational methods in reducing preoperative anxiety and physiological stress response.
調査の概要
状態
詳細な説明
Preoperative anxiety is common among women undergoing elective cesarean delivery and may contribute to increased physiological stress responses, including elevated serum cortisol levels. Effective preoperative education may improve patient understanding of the surgical and anesthetic process and reduce anxiety.
This single-center prospective randomized controlled trial will be conducted at Elazig Fethi Sekin City Hospital. Women aged 18 years or older who are scheduled for elective cesarean delivery under spinal anesthesia and provide written informed consent will be eligible for participation.
Participants will be randomly allocated to one of two groups:
Verbal Education Group:
Participants will receive routine face-to-face verbal information regarding the surgical procedure and spinal anesthesia from an anesthesiologist.
- Video-Based Education Group:
Participants will watch a standardized educational video covering the same information provided in the verbal education group.
Educational interventions will be delivered at least one hour before surgery.
Anxiety levels will be assessed using the State-Trait Anxiety Inventory-State (STAI-S) before and after the educational intervention. Serum cortisol concentrations will be measured from venous blood samples obtained during routine clinical blood collection before and after education.
The primary outcomes are changes in STAI-S scores and serum cortisol levels following the educational intervention. Secondary analyses will evaluate the relationship between educational modality and physiological stress response.
A total of 140 participants are planned for enrollment, with 70 participants in each study group.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sevim Şenol Karataş, MD
- 電話番号：+905325736611
- メール：drsevimkaratas@gmail.com
研究連絡先のバックアップ
- 名前：Sait F Öner, MD
- 電話番号：+90 533 627 13 58
- メール：sfatihoner@gmail.com
研究場所
-
-
Elâzığ
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Elâzığ、Elâzığ、トルコ（Türkiye）、23100
- Elazığ Fethi Sekin City Hospital
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主任研究者：
- Sevim Şenol Karataş, MD
-
コンタクト：
- Sevim Şenol Karataş, MD
- 電話番号：+90 532 573 6611
- メール：drsevimkaratas@gmail.com
-
コンタクト：
- Sait F Öner, MD
- 電話番号：+90 533 627 13 58
- メール：sfatihoner@gmail.com
-
副調査官：
- Sait F Öner, MD
-
副調査官：
- Cengiz Şanlı, MD
-
-
参加基準
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
説明
Inclusion Criteria:
- Female participants aged 18 years or older
- Scheduled for elective cesarean delivery
- Planned to undergo spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Emergency cesarean delivery
- History of psychiatric disease
- Current use of anxiolytic or antidepressant medications
- Endocrine disorders, including adrenal or thyroid disease
- Current corticosteroid therapy
- Previous surgery performed under spinal anesthesia
- Cognitive impairment or communication difficulties that may interfere with completion of anxiety assessments
- ASA physical status III, IV, or V
研究計画
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Video-Based Education
Participants receive standardized video-based preoperative education before elective cesarean delivery.
|
Participants will watch a standardized preoperative educational video providing information about cesarean delivery, spinal anesthesia, the perioperative process, potential risks and complications, postoperative expectations, and recovery.
The video is designed to improve patient understanding and reduce preoperative anxiety.
|
|
アクティブコンパレータ：Verbal Education
Participants receive standard verbal preoperative education before elective cesarean delivery.
|
Participants will receive standard face-to-face verbal preoperative education from an anesthesiologist regarding cesarean delivery, spinal anesthesia, the perioperative process, potential risks and complications, postoperative expectations, and recovery.
|
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 |
|---|---|---|
|
Change in STAI-S Score
時間枠：Before education and immediately after education on the day of surgery
|
Change in State-Trait Anxiety Inventory-State (STAI-S) score from before to after preoperative education.
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Before education and immediately after education on the day of surgery
|
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Change in Serum Cortisol Level
時間枠：Before education and immediately after education on the day of surgery
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Change in serum cortisol concentration from before to after preoperative education.
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Before education and immediately after education on the day of surgery
|
協力者と研究者
捜査官
- 主任研究者：Sevim Şenol Karataş、Elazıg Fethi Sekin Sehir Hastanesi
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- QR Code-Cesarean
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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