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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-Based Education | Experimental | Participants receive standardized video-based preoperative education before elective cesarean delivery. |
|
| Verbal Education | Active Comparator | Participants receive standard verbal preoperative education before elective cesarean delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-Based Preoperative Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in State-Trait Anxiety Inventory-State (STAI-S) Score | 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. | Before education and immediately after education on the day of surgery |
| Change in Serum Cortisol Level | Change in serum cortisol concentration (µg/dL) from before to after preoperative education. Higher serum cortisol levels indicate greater physiological stress response. | Before education and immediately after education on the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sevim Şenol Karataş, MD | Contact | +905325736611 | drsevimkaratas@gmail.com | |
| Sait F Öner, MD | Contact | +90 533 627 13 58 | sfatihoner@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sevim Şenol Karataş | Elazıg Fethi Sekin Sehir Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elazığ Fethi Sekin City Hospital | Elâzığ | Elâzığ | 23100 | Turkey (Türkiye) |
Individual participant data will not be made publicly available. Data contain potentially identifiable clinical information and were collected under local ethics committee approval and informed consent procedures that do not include public data sharing.
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |
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Participants will be randomly assigned in a 1:1 ratio to receive either standard verbal preoperative education or a standardized video-based educational intervention before elective cesarean delivery. Outcomes will be compared between parallel groups.
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| Verbal Preoperative Education | Behavioral | 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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