Cesarean Delivery, Preoperative Anxiety, Stress Response
Conditions
Keywords
Preoperative Education, Video-Based Education, Verbal Education, Cesarean Section, Spinal Anesthesia, Anxiety, Serum Cortisol, STAI, Randomized Controlled Trial
Brief summary
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
BEHAVIORALVideo-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.
BEHAVIORALVerbal 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.
Sponsors
Elazıg Fethi Sekin Sehir Hastanesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and the researcher delivering the intervention were not blinded because of the nature of the intervention. The outcomes assessor and laboratory personnel were blinded to group allocation. Before statistical analysis, study groups were coded as A and B, and the primary analyses were performed by a researcher unaware of group identity.
Intervention model description
Participants were randomly assigned in a 1:1 ratio to receive either standardized verbal preoperative information or a standardized video-based educational intervention before elective cesarean delivery. Outcomes were compared between the two parallel groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in State-Trait Anxiety Inventory-State (STAI-S) Score | Before education and immediately after education on the day of surgery | Change in STAI-S score from before to after preoperative education. The STAI-S consists of 20 items with total scores ranging from 20 to 80. Higher scores indicate greater anxiety. |
| Change in Serum Cortisol Level | Before education and immediately after education on the day of surgery | Change in serum cortisol concentration (µg/dL) from before to after preoperative education. Higher serum cortisol levels indicate greater physiological stress response. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORSevim Şenol Karataş
Elazıg Fethi Sekin Sehir Hastanesi
Outcome results
None listed