Surgical Anxiety Scale for Adult PatientsEducationNCT07419529
Effect of Artificial Intelligence-Based Education Before Planned Cesarean Section on Surgical Fear, Anxiety, and Postpartum Comfort Levels of Primigravida Women
A study testing individual education about cesarean surgery, about cesarean surgery using artificial intelligence and routine maintenance of the institution in people with Surgical Anxiety Scale for Adult Patients and Surgical Fear Scale, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 months, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Anxiety Scale for Adult Patients, Surgical Fear Scale, Postpartum Comfort Scale
- What is being tested?
- individual education about cesarean surgery, about cesarean surgery using artificial intelligence and routine maintenance of the institution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 31 Dec 2025
- 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 to 35 months
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- individual education about cesarean surgery, about cesarean surgery using artificial intelligence, routine maintenance of the institution
- Keywords
- fear, Anxiety, Comfort, artificial intelligence
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual education about cesarean surgeryOther
Women will be given individual training about cesarean surgery.
about cesarean surgery using artificial intelligenceOther
Training on Caesarean section surgery with artificial intelligence
routine maintenance of the institutionOther
Women in this group will not be given training on any subject.
| Study group | Role | What they receive |
|---|---|---|
| Individualized education about cesarean section surgery | Experimental | individualized education Receives: Other: individual education about cesarean surgery |
| AI-based training on cesarean section surgery | Experimental | AI-assisted education Receives: Other: about cesarean surgery using artificial intelligence |
| routine maintenance | Other | institutional routine maintenance Receives: Other: routine maintenance of the institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours before and after 2 hours of surgery
Secondary outcomes (2)
Perianesthesia Comfort Scale
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.
Measured: 24 hours after the cesarean section surgery.
Postpartum Comfort Scale
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.
Measured: 24 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start15 Aug 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Anxiety Scale for Adult PatientsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birnur Yeşildağ, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419529
- Sponsor's protocol ID
- NİĞDE ÖMER HALİSDEMİR UNIVERCI
- Acronym
- Education
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07419529
- Acronym / sponsor ID
- Education / NİĞDE ÖMER HALİSDEMİR UNIVERCI
- Keywords
- fear, Anxiety, Comfort, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Feb 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized education about cesarean section surgery | Experimental | Other: individual education about cesarean surgeryindividualized education |
| AI-based training on cesarean section surgery | Experimental | Other: about cesarean surgery using artificial intelligenceAI-assisted education |
| routine maintenance | Other | Other: routine maintenance of the institutioninstitutional routine maintenance |
Who may qualify
- Ages
- 18 to 35 months
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| individual education about cesarean surgeryWomen will be given individual training about cesarean surgery. | Other | Individualized education about cesarean section surgery |
| about cesarean surgery using artificial intelligenceTraining on Caesarean section surgery with artificial intelligence | Other | AI-based training on cesarean section surgery |
| routine maintenance of the institutionWomen in this group will not be given training on any subject. | Other | routine maintenance |
Primary outcome
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.
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.
2 secondary outcomes
Perianesthesia Comfort Scale
Time frame: 24 hours after the cesarean section surgery.
Postpartum Comfort Scale
Time frame: 24 hours after cesarean section
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 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Surgical Anxiety Scale for Adult Patients
Recruiting
Green Light for Post-Operative Wellness
Surgery
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?
A study testing individual education about cesarean surgery, about cesarean surgery using artificial intelligence and routine maintenance of the institution in people with Surgical Anxiety Scale for Adult Patients and Surgical Fear Scale, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 4 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 9 Jul 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?
Surgical Anxiety Scale for Adult Patients (time frame: 2 hours before and after 2 hours of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.