NCT07419529

Brief Summary

This study was planned to determine the effect of artificial intelligence use before planned cesarean section on surgical fear, anxiety and postpartum comfort levels of primigravida women. The research will be conducted in an experimental design. The research will be initiated after obtaining written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women between the ages of 18-35, who are primigravida, who applied for planned cesarean section, who have live singleton pregnancies and who are planned for spinal anesthesia will be included in the research. Before starting the research, the study will be initiated after obtaining the institutional permissions and written permissions from the pregnant women. Preliminary Assessment Form, Personal Information Form, Surgical Fear Scale, Surgical Anxiety Scale for Adult Patients, Postpartum Comfort Scale and Perianesthesia Comfort Scale will be used in data collection. Data will be evaluated in a computer environment using IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used in data evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 13, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

fearAnxietyComfortartificial intelligence

Outcome Measures

Primary Outcomes (2)

  • Surgical Anxiety Scale for Adult Patients

    The scale is a five-point Likert-type instrument ranging from "not anxious at all" to "extremely anxious" and does not include any reverse-coded items. Total and subscale scores are calculated by summing the relevant items, with higher scores indicating higher levels of anxiety.

    2 hours before and after 2 hours of surgery

  • Surgical Fear Scale

    The scale consists of eight items rated on an 11-point Likert scale ranging from 0 ("not afraid at all") to 10 ("very afraid") and is designed to assess fear related to surgery. It comprises two subdimensions measuring fear of the short-term and long-term consequences of surgery. Total scale scores range from 0 to 80, while subscale scores range from 0 to 40, with higher scores indicating greater levels of surgical fear.

    2 hours before and after 2 hours of surgery

Secondary Outcomes (2)

  • Perianesthesia Comfort Scale

    2 hours after the cesarean section surgery.

  • Postpartum Comfort Scale

    2 hours after cesarean section

Study Arms (3)

Individualized education about cesarean section surgery

EXPERIMENTAL

individualized education

Other: individual education about cesarean surgery

AI-based training on cesarean section surgery

EXPERIMENTAL

AI-assisted education

Other: about cesarean surgery using artificial intelligence

routine maintenance

OTHER

institutional routine maintenance

Other: routine maintenance of the institution

Interventions

Women will be given individual training about cesarean surgery.

Individualized education about cesarean section surgery

Training on Caesarean section surgery with artificial intelligence

AI-based training on cesarean section surgery

Women in this group will not be given training on any subject.

routine maintenance

Eligibility Criteria

Age18 Months - 35 Months
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Are between 18 and 35 years of age
  • Are primigravida
  • Are applying for a planned cesarean section
  • Have a live singleton pregnancy
  • Are scheduled for spinal anesthesia

You may not qualify if:

  • Women with known mental health problems,
  • Those who have performed relaxation exercises during pregnancy,
  • Women who have developed maternal or neonatal complications after birth,
  • Those who have received general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir Univercity

Niğde, 51100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 13, 2025

First Posted

February 19, 2026

Study Start

August 15, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 19, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations