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NCT Number: NCT07521592

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

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."

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Key information

Conditions

Preoperative Anxiety Cesarean Section Cortisol Surgical Stress Response

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elazığ Fethi Sekin City Hospital

Elâzığ, Lütfen Seçiniz., 23100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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