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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sevim Şenol Karataş, MD
- 전화번호: +905325736611
- 이메일: drsevimkaratas@gmail.com
연구 연락처 백업
- 이름: Sait F Öner, MD
- 전화번호: +90 533 627 13 58
- 이메일: sfatihoner@gmail.com
연구 장소
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Elâzığ
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Elâzığ, Elâzığ, 터키 (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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수석 연구원:
- Sevim Şenol Karataş, MD
-
연락하다:
- Sevim Şenol Karataş, MD
- 전화번호: +90 532 573 6611
- 이메일: drsevimkaratas@gmail.com
-
연락하다:
- Sait F Öner, MD
- 전화번호: +90 533 627 13 58
- 이메일: sfatihoner@gmail.com
-
부수사관:
- Sait F Öner, MD
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부수사관:
- Cengiz Şanlı, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Video-Based Education
Participants receive standardized video-based preoperative education before elective cesarean delivery.
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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.
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활성 비교기: Verbal Education
Participants receive standard verbal preoperative education before elective cesarean delivery.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in State-Trait Anxiety Inventory-State (STAI-S) Score
기간: Before education and immediately after education on the day of surgery
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Change in STAI-S score from before to after preoperative education.
The STAI-S consists of 20 items with total scores ranging from 20 to 80. Higher scores indicate greater anxiety.
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Before education and immediately after education on the day of surgery
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Change in Serum Cortisol Level
기간: Before education and immediately after education on the day of surgery
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Change in serum cortisol concentration (µg/dL) from before to after preoperative education.
Higher serum cortisol levels indicate greater physiological stress response.
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Before education and immediately after education on the day of surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- QR Code-Cesarean
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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