- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419529
Effect of Artificial Intelligence-Based Education Before Planned Cesarean Section on Surgical Fear, Anxiety, and Postpartum Comfort Levels of Primigravida Women (Education)
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
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Niğde, Turkey (Türkiye), 51100
- Niğde Ömer Halisdemir Univercity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individualized education about cesarean section surgery
individualized education
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Women will be given individual training about cesarean surgery.
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Experimental: AI-based training on cesarean section surgery
AI-assisted education
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Training on Caesarean section surgery with artificial intelligence
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Other: routine maintenance
institutional routine maintenance
|
Women in this group will not be given training on any subject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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2 hours before and after 2 hours of surgery
|
|
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.
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2 hours before and after 2 hours of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perianesthesia Comfort Scale
Time Frame: 2 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.
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2 hours after the cesarean section surgery.
|
|
Postpartum Comfort Scale
Time Frame: 2 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.
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2 hours after cesarean section
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NİĞDE ÖMER HALİSDEMİR UNIVERCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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