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

April 8, 2026 updated by: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi

The Effect of Video-Based Versus Verbal Preoperative Information on Anxiety and Serum Cortisol Levels in Elective Cesarean Section: A Prospective Randomized Controlled Study

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."

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Verbal Information Group
Behavioral: Verbal Preoperative Information
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.
Other: Video-Based Information Group
Behavioral: Video-Based Preoperative Information
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in preoperative anxiety level measured by the State-Trait Anxiety Inventory (STAI-S)
Time Frame: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum cortisol level change
Time Frame: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery
Change in serum cortisol levels measured from venous blood samples obtained immediately before preoperative information and approximately 1 hour after preoperative information, before surgery.
Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EFSH-CS-ANX-CORT-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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