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Not yet recruiting NCT07647601

Video Versus Verbal Preoperative Education in Elective Cesarean Delivery

No phase Interventional Preoperative Anxiety Cesarean Delivery Stress Response

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-Based Preoperative Education, Verbal Preoperative Education.
Who it may be relevant to
Registry conditions: Preoperative Anxiety, Cesarean Delivery, Stress Response. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Change in State-Trait Anxiety Inventory-State (STAI-S) Score [Time frame: Before education and immediately after education on the day of surgery]
  • Change in Serum Cortisol Level [Time frame: Before education and immediately after education on the day of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Elazığ Fethi Sekin City Hospital — Elâzığ

Identifiers

NCT: NCT07647601 · QR Code-Cesarean

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗