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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preoperative Anxiety; Stress Response; Cesarean Delivery
• Intervention / Treatment: Behavioral: Video-Based Preoperative Education; Behavioral: Verbal Preoperative Education

Detailed Description

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:

1. Verbal Education Group:

   Participants will receive routine face-to-face verbal information regarding the surgical procedure and spinal anesthesia from an anesthesiologist.

2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sevim Şenol Karataş, MD; Phone Number: +905325736611; Email: drsevimkaratas@gmail.com
• Study Contact Backup: Name: Sait F Öner, MD; Phone Number: +90 533 627 13 58; Email: sfatihoner@gmail.com

Study Locations

• Turkey (Türkiye)
  • Elâzığ
    • Elâzığ, Elâzığ, Turkey (Türkiye), 23100
      • Elazığ Fethi Sekin City Hospital
      • Principal Investigator: Sevim Şenol Karataş, MD
      • Contact: Sevim Şenol Karataş, MD; Phone Number: +90 532 573 6611; Email: drsevimkaratas@gmail.com
      • Contact: Sait F Öner, MD; Phone Number: +90 533 627 13 58; Email: sfatihoner@gmail.com
      • Sub-Investigator: Sait F Öner, MD
      • Sub-Investigator: Cengiz Şanlı, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-Based Education; Participants receive standardized video-based preoperative education before elective cesarean delivery.	Behavioral: Video-Based Preoperative Education; 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.
Active Comparator: Verbal Education; Participants receive standard verbal preoperative education before elective cesarean delivery.	Behavioral: Verbal Preoperative Education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Elazıg Fethi Sekin Sehir Hastanesi
• Investigators: Principal Investigator: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 20, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Randomized Controlled Trial; STAI; Cesarean Section; Spinal Anesthesia; Serum Cortisol; Preoperative Education; Video-Based Education; Verbal Education
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Fractures, Bone; Anxiety Disorders; Fractures, Stress
• Other Study ID Numbers: QR Code-Cesarean

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No