Preoperative AnxietyVIDEO-CSNCT07647601
Video Versus Verbal Preoperative Education in Elective Cesarean Delivery
A study testing Video-Based Preoperative Education and Verbal Preoperative Education in people with Preoperative Anxiety and Cesarean Delivery, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preoperative Anxiety, Cesarean Delivery, Stress Response
- What is being tested?
- Video-Based Preoperative Education and Verbal Preoperative Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2026to 2 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Elâzığ, 23100
About this study
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
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.
Read the 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:
- Verbal Education Group: Participants will receive routine face-to-face verbal information regarding the surgical procedure and spinal anesthesia from an anesthesiologist.
- 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.
- Conditions
- Preoperative Anxiety, Cesarean Delivery, Stress Response
- Being tested
- Video-Based Preoperative Education, Verbal Preoperative Education
- Keywords
- Preoperative Education, Video-Based Education, Verbal Education, Cesarean Section, Spinal Anesthesia, Anxiety, Serum Cortisol, STAI, Randomized Controlled Trial
- Medical subject headings
- Fractures, Stress, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Preoperative EducationBehavioural
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.
Verbal Preoperative EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-Based Education | Experimental | Participants receive standardized video-based preoperative education before elective cesarean delivery. Receives: Behavioral: Video-Based Preoperative Education |
| Verbal Education | Active comparator | Participants receive standard verbal preoperative education before elective cesarean delivery. Receives: Behavioral: Verbal Preoperative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory-State (STAI-S) Score
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.
Measured: Before education and immediately after education on the day of surgery
Change in Serum Cortisol Level
Change in serum cortisol concentration (µg/dL) from before to after preoperative education. Higher serum cortisol levels indicate greater physiological stress response.
Measured: Before education and immediately after education on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start2 Apr 2026
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevim Şenol Karataş, Principal investigator, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647601
- Sponsor's protocol ID
- QR Code-Cesarean
- Acronym
- VIDEO-CS
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Data contain potentially identifiable clinical information and were collected under local ethics committee approval and informed consent procedures that do not include public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07647601
- Acronym / sponsor ID
- VIDEO-CS / QR Code-Cesarean
- Conditions
- Preoperative Anxiety, Cesarean Delivery, Stress Response
- Keywords
- Preoperative Education, Video-Based Education, Verbal Education, Cesarean Section, Spinal Anesthesia, Anxiety, Serum Cortisol, STAI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Verbal Education Group: Participants will receive routine face-to-face verbal information regarding the surgical procedure and spinal anesthesia from an anesthesiologist.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video-Based Education | Experimental | Behavioral: Video-Based Preoperative EducationParticipants receive standardized video-based preoperative education before elective cesarean delivery. |
| Verbal Education | Active comparator | Behavioral: Verbal Preoperative EducationParticipants receive standard verbal preoperative education before elective cesarean delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Emergency cesarean delivery
- History of psychiatric disease
- Current use of anxiolytic or antidepressant medications
- Endocrine disorders, including adrenal or thyroid disease
- Current corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Based Preoperative EducationParticipants 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. | Behavioural | Video-Based Education |
| Verbal Preoperative EducationParticipants 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. | Behavioural | Verbal Education |
Primary outcome
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 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Data contain potentially identifiable clinical information and were collected under local ethics committee approval and informed consent procedures that do not include public data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Şenol Karataş principal investigator
Elazıg Fethi Sekin Sehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Preoperative Education and Verbal Preoperative Education in people with Preoperative Anxiety and Cesarean Delivery, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State-Trait Anxiety Inventory-State (STAI-S) Score (time frame: Before education and immediately after education on the day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.