Preoperative AnxietyNCT07521592

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

A study testing Verbal Preoperative Information and Video-Based Preoperative Information in people with Preoperative Anxiety and Cesarean Section, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Preoperative Anxiety, Cesarean Section, Surgical Stress Response
What is being tested?: Verbal Preoperative Information and Video-Based Preoperative Information
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Elazığ Fethi Sekin City Hospital
Elâzığ, Lütfen Seçiniz., 23100

Other trials in Turkey (Türkiye)

About this study

Official 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

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."

Conditions: Preoperative Anxiety, Cesarean Section, Surgical Stress Response, Cortisol
Being tested: Verbal Preoperative Information, Video-Based Preoperative Information
Keywords: Preoperative Anxiety, Cesarean Delivery, Cortisol Biomarker

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Verbal Preoperative InformationBehavioural
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 InformationBehavioural
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.

Study groups in NCT07521592
Study group	Role	What they receive
Verbal Information Group	Other	Not described Receives: Behavioral: Verbal Preoperative Information
Video-Based Information Group	Other	Not described Receives: Behavioral: Video-Based Preoperative Information

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 20262 Jul 2026

First posted13 Apr 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07521592
Sponsor's protocol ID: EFSH-CS-ANX-CORT-2026-01
Status last verified: Aug 2026
First submitted: 1 Apr 2026
Last updated: 26 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.
Preoperative Anxiety Score
Recruiting
Positive Affirmations and Preoperative Anxiety
Total Joint Replacement Surgery, Preoperative Anxiety

All Preoperative Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07521592
Acronym / sponsor ID: EFSH-CS-ANX-CORT-2026-01
Conditions: Preoperative Anxiety, Cesarean Section, Surgical Stress Response, Cortisol
Keywords: Preoperative Anxiety, Cesarean Delivery, Cortisol Biomarker
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: 13 Apr 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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Verbal Information Group	Other	Behavioral: Verbal Preoperative Information
Video-Based Information Group	Other	Behavioral: Video-Based Preoperative Information

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)

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

Key exclusion criteria (8 listed)

Emergency cesarean delivery
History of psychiatric disorders
Current use of anxiolytic or antidepressant medications
Endocrine disorders, particularly 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
Verbal Preoperative InformationParticipants 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.	Behavioural	Verbal Information Group
Video-Based Preoperative InformationParticipants 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.	Behavioural	Video-Based Information Group

Primary outcome

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.

1 secondary outcome

Serum cortisol level change
Time frame: Immediately before preoperative information and approximately 1 hour after preoperative information, before surgery

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 26 Aug 2026.

Related trials for Preoperative Anxiety

Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.
Preoperative Anxiety Score
Recruiting
Positive Affirmations and Preoperative Anxiety
Total Joint Replacement Surgery, Preoperative Anxiety

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 26 Aug 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 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07521592.

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 26 Aug 2026.