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Completed

NCT Number: NCT07419529

Effect of Artificial Intelligence-Based Education Before Planned Cesarean Section on Surgical Fear, Anxiety, and Postpartum Comfort Levels of Primigravida Women

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.

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Key information

Age range

18 month–35 month

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Niğde Ömer Halisdemir Univercity

Niğde, 51100, Turkey (Türkiye)

About this study

The frequency of cesarean sections is increasing worldwide .The WHO reports that approximately 18.6 million cesarean sections are performed annually. The frequency of cesarean sections in Turkey is increasing annually. According to the 2021 Health Statistics Yearbook, the rate of cesarean sections among live births is 58.4%, while the rate of primary cesarean sections among live births is 29.1%. These rates are significantly higher than the ideal cesarean rate, which is set by the WHO as 10-15%.

While there are many known reasons for the increase in cesarean sections, more than 80% of women experience fear and anxiety before and during cesarean sections. A significant portion of women undergoing cesarean sections experience high levels of anxiety before the procedure . Research shows that 63-86% of women undergoing a cesarean section have higher levels of fear and anxiety compared to those undergoing general surgery. Anxiety related to cesarean surgery has been associated with physiological and psychological risks. Fear and anxiety experienced before a cesarean section can affect hormone levels and trigger responses from both the sympathetic and parasympathetic nervous systems. Consequently, these responses can lead to increased blood pressure and heart rate and cardiac arrhythmia. Furthermore, excessive fear and anxiety before and during surgery can lead to anesthesia complications, increased need for postoperative pain relief, prolonged recovery, delayed breastfeeding initiation and discharge, higher costs, and decreased satisfaction with the birth experience .Therefore, addressing and reducing fear and anxiety related to cesarean section is crucial, as lower levels of fear and anxiety before and during surgery have been linked to greater maternal satisfaction and a more positive overall birth experience. Managing fear and anxiety can be approached with both pharmaceutical and non-pharmacological methods. While widely used, pharmaceutical approaches can be expensive, sometimes painful, and carry the risk of potential adverse effects on the fetus if they cross the placenta..Therefore, there is a focus on using non-pharmacological techniques to alleviate fear and anxiety in women undergoing cesarean section . Education is a powerful example. Recently, the use of artificial intelligence has increased, and many people have begun using AI for pregnancy, birth, and postpartum processes.

Given the high incidence of cesarean sections and the prevalence of anxiety and fear as psychological symptoms, providing comfort support to women is crucial. Therefore, the aim of this study was to determine the effect of informing primigaravida women with artificial intelligence before planned cesarean section on their surgical fear, anxiety and postpartum comfort levels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

individual education about cesarean surgery

Other

Women will be given individual training about cesarean surgery.

about cesarean surgery using artificial intelligence

Other

Training on Caesarean section surgery with artificial intelligence

routine maintenance of the institution

Other

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

Primary outcomes

  1. Surgical Anxiety Scale for Adult Patients

    Time frame: 2 hours before and after 2 hours of surgery

    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. Surgical Fear Scale

    Time frame: 2 hours before and after 2 hours of surgery

    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.

Secondary outcomes

  1. Perianesthesia Comfort Scale

    Time frame: 24 hours after the cesarean section surgery.

    The scale consists of 24 items rated on a 6-point Likert scale and assesses individuals' general thoughts and feelings related to the preoperative, intraoperative, and postoperative periods. Items are scored from 1 ("strongly disagree") to 6 ("strongly agree") and include both positively and negatively worded statements. Negatively worded items are reverse-coded before calculating the total score. The total score of the scale ranges from 24 to 144, and the mean score is obtained by dividing the total score by the number of items, resulting in a value between 1 and 6. Higher scores indicate a better level of perianesthesia comfort, whereas lower scores reflect poorer comfort levels.

  2. Postpartum Comfort Scale

    Time frame: 24 hours after cesarean section

    The scale consists of 34 items and includes three subdimensions: physical, psychospiritual, and sociocultural comfort. The scale is rated on a five-point Likert scale, with items scored either directly or reverse-coded depending on their wording. The total score of the scale ranges from 34 to 170, and the mean score is calculated by dividing the total score by the number of items, yielding a value between 1 and 5. Higher scores indicate higher levels of postpartum comfort.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Effect of Artificial Intelligence-Based Education Before Planned Cesarean Section on Surgical Fear, Anxiety, and Postpartum Comfort Levels of Primigravida Women: A Randomized Controlled Trial

Acronym: Education

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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