NCT07647601

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jun 2026Jul 2026

First Submitted

Initial submission to the registry

June 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Preoperative EducationVideo-Based EducationVerbal EducationCesarean SectionSpinal AnesthesiaAnxietySerum CortisolSTAIRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Change in STAI-S Score

    Change in State-Trait Anxiety Inventory-State (STAI-S) score from before to after preoperative education.

    Before education and immediately after education on the day of surgery

  • Change in Serum Cortisol Level

    Change in serum cortisol concentration from before to after preoperative education.

    Before education and immediately after education on the day of surgery

Study Arms (2)

Video-Based Education

EXPERIMENTAL

Participants receive standardized video-based preoperative education before elective cesarean delivery.

Behavioral: Video-Based Preoperative Education

Verbal Education

ACTIVE COMPARATOR

Participants receive standard verbal preoperative education before elective cesarean delivery.

Behavioral: Verbal Preoperative Education

Interventions

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.

Video-Based 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.

Verbal Education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fractures, StressAnxiety Disorders

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesMental Disorders

Study Officials

  • Sevim Şenol Karataş

    Elazıg Fethi Sekin Sehir Hastanesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevim Şenol Karataş, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either standard verbal preoperative education or a standardized video-based educational intervention before elective cesarean delivery. Outcomes will be compared between parallel groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations