Effect of Video-Based Versus Verbal Preoperative Information on Anxiety and Cortisol Levels in Elective Cesarean Section

NCT07521592 | Not Yet Recruiting

• 1 other identifier: EFSH-CS-ANX-CORT-2026-01
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preoperative anxiety is a common problem in patients undergoing elective cesarean section and may negatively affect perioperative outcomes through activation of the stress response, including increased cortisol levels. Effective preoperative information is considered a key non-pharmacological strategy to reduce anxiety; however, the optimal method of information delivery remains unclear. This prospective randomized controlled trial aims to compare the effects of video-based versus verbal preoperative information on anxiety levels and serum cortisol response in patients scheduled for elective cesarean delivery under spinal anesthesia. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), and serum cortisol levels will be measured before and after the intervention. The findings of this study are expected to provide evidence for improving patient-centered preoperative education strategies in obstetric anesthesia."

Conditions

Preoperative Anxiety; Cesarean Section; Surgical Stress Response; Cortisol

Keywords

Preoperative Anxiety; Cesarean Delivery; Cortisol Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in preoperative anxiety level measured by the State-Trait Anxiety Inventory (STAI-S)

  Change in preoperative anxiety level measured by the State-Trait Anxiety Inventory-State (STAI-S), a 20-item scale with scores ranging from 20 to 80, where higher scores indicate greater anxiety.

  Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

Secondary Outcomes (1)

• Serum cortisol level change

  Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

Study Arms (2)

Verbal Information Group

OTHER

Behavioral: Verbal Preoperative Information

Video-Based Information Group

OTHER

Behavioral: Video-Based Preoperative Information

Interventions

Video-Based Preoperative Information BEHAVIORAL

Participants will receive standardized video-based preoperative information covering anesthesia and the surgical procedure at least one hour before surgery. The content of the video will be equivalent to the verbal information provided in routine clinical practice.

Video-Based Information Group

Verbal Preoperative Information BEHAVIORAL

Participants will receive standard preoperative information about anesthesia and the surgical procedure through face-to-face verbal communication delivered by an anesthesiologist according to routine clinical practice at least one hour before surgery.

Verbal Information Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 18 years or older
• Scheduled for elective cesarean delivery
• Planned to receive spinal anesthesia
• American Society of Anesthesiologists (ASA) physical status I-II
• Ability to provide written informed consent

You may not qualify if:

• Emergency cesarean delivery
• History of psychiatric disorders
• Current use of anxiolytic or antidepressant medications
• Endocrine disorders, particularly adrenal or thyroid disease
• Current corticosteroid therapy
• History of previous surgery under spinal anesthesia
• Cognitive impairment preventing effective communication or completion of the assessment scales
• American Society of Anesthesiologists (ASA) physical status III-V

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Central Study Contacts

Sevim ŞENOL KARATAŞ, MD

CONTACT

05325736611; drsevimkaratas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04