CClinicalTrials.gg
CompletedNCT07521592Updated Aug 26, 2026

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

An interventional study of Verbal Preoperative Information and Video-Based Preoperative Information in Preoperative Anxiety, Cesarean Section and Surgical Stress Response, sponsored by Elazıg Fethi Sekin Sehir Hastanesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Elazıg Fethi Sekin Sehir Hastanesi · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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."

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Conditions studied

  • Preoperative Anxiety
  • Cesarean Section
  • Surgical Stress Response
  • Cortisol

Keywords

  • Preoperative Anxiety
  • Cesarean Delivery
  • Cortisol Biomarker
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In context

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Other
    Verbal Information Group

    Behavioral: Verbal Preoperative Information

  • Other
    Video-Based Information Group

    Behavioral: Video-Based Preoperative Information

Interventions

  • BehavioralVerbal 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.

  • BehavioralVideo-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.

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What researchers measure

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.

    Time frame: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

Secondary outcomes

  1. Serum cortisol level change

    Change in serum cortisol levels measured from venous blood samples obtained immediately before preoperative information and approximately 1 hour after preoperative information, before surgery.

    Time frame: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

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Study locations

1 site
  • Elazığ Fethi Sekin City Hospital
    Elâzığ, Lütfen Seçiniz. 23100, Turkey (Türkiye)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07521592
Lead sponsor
Elazıg Fethi Sekin Sehir Hastanesi
Responsible party
Sevim Şenol Karataş (Principal Investigator, Elazıg Fethi Sekin Sehir Hastanesi) — Principal investigator
First posted
Apr 13, 2026
Start date
Apr 2, 2026
Primary completion
Jul 2, 2026
Completion
Jul 2, 2026
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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