Effect of Video-Based Versus Verbal Preoperative Information on Anxiety and Cortisol Levels in El… (NCT07521592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Video-Based Versus Verbal Preoperative Information on Anxiety and Cortisol Levels in Elective Cesarean Section
140 participantsStarted 2026-04-02
Plain-language 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."
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in preoperative anxiety level measured by the State-Trait Anxiety Inventory (STAI-S)
Timeframe: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery