The impact of ChatGPT on preoperative anxiety and postoperative depression in cesarean section
| ISRCTN | ISRCTN13770889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13770889 |
| Sponsor | Lokman Hekim Üniversitesi |
| Funder | Investigator initiated and funded |
- Submission date
- 17/03/2026
- Registration date
- 18/03/2026
- Last edited
- 18/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
This study aims to evaluate whether using ChatGPT as an additional source of information can reduce anxiety before cesarean section and depression after delivery. The findings of this study may help improve patient education and emotional well-being in women undergoing cesarean section.
Who can participate?
Adult pregnant women aged ≥18 years who are scheduled for cesarean section.
What does the study involve?
Women scheduled for cesarean section were randomly assigned to two groups. One group received standard information from their doctor, while the other group received both standard information and additional support using ChatGPT. Participants were able to ask questions and receive detailed explanations through ChatGPT.
The study measured anxiety levels before the operation and depression levels after delivery using validated questionnaires. Pain levels after the procedure were also evaluated.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Ankara Atatürk Sanatoryum Research and Training Hospital, Turkey.
When is the study starting and how long is it expected to run for?
September 2023 to December 2024.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Dr Bengü Mutlu Sütcüoğlu, bengu.sutcuoglu@saglik.gov.tr, drbengumutlu@gmail.com
Contact information
Principal investigator, Scientific, Public
Department of Obstetrics and Gynaecology
Ankara Atatürk Sanatoryum Research and Training Hospital
Ankara
06150
Türkiye
 ORCID ID |
0000-0002-5594-1719 |
|---|---|
| Phone | +90 55 44932639 |
| bengu.sutcuoglu@saglik.gov.tr |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Supportive care |
| Scientific title | A prospective randomized controlled trial evaluating the impact of ChatGPT-supported patient education on preoperative anxiety and postoperative depression in women undergoing cesarean section |
| Study acronym | CHAT-CES Study |
| Study objectives | The primary objective of this study is to evaluate the effect of ChatGPT-supported patient education on preoperative anxiety in women undergoing cesarean section. Secondary objectives include assessing the impact of this intervention on postoperative depression levels and postoperative pain scores. |
| Ethics approval(s) |
Approved 20/09/2023, Lokman Hekim University Scientific Research Ethics Committee (Lokman Hekim Üniversitesi Bilimsel Araştırmalar Etik Kurulu) (Söğütözü Neighborhood, 9 Eylül Street No 6, Ankara, 06150, Türkiye; +90 312 444 8 548; info@lokmanhekim.edu.tr), ref: 2023158 |
| Health condition(s) or problem(s) studied | Preoperative anxiety and postoperative depression in women undergoing cesarean section |
| Intervention | Participants were randomly assigned in a 1:1 ratio using a computer-generated randomization sequence to either the intervention group or the control group. Allocation was implemented using sealed, opaque envelopes prepared prior to study initiation. Intervention group: Participants received standard physician consultation along with additional support using ChatGPT. ChatGPT was used to provide individualized, accessible, and interactive information regarding the cesarean section procedure, including preoperative preparation, intraoperative expectations, and postoperative care. Participants were able to interact with ChatGPT to ask questions and receive real-time responses. Control group: Participants received standard physician consultation only, which included routine preoperative information provided by healthcare professionals. All participants were assessed for preoperative anxiety using the State-Trait Anxiety Inventory (STAI) prior to the procedure. Postoperative depression was evaluated using the Edinburgh Postnatal Depression Scale (EPDS), and postoperative pain was assessed using a standardized pain scale. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 10/12/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | 1. Pregnant women scheduled for cesarean section 2. Age ≥18 years 3. Ability to understand and communicate in Turkish 4. Ability to use a smartphone or digital device 5. Willingness to provide informed consent |
| Key exclusion criteria | 1. Women with a history of psychiatric disorders or current psychiatric treatment 2. Inability to understand or communicate in turkish 3. Inability to use a smartphone or digital device 4. Refusal to provide informed consent 5. Emergency cesarean section |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- Türkiye
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 18/03/2026 | No | No |
Additional files
- 49217_Protocol.pdf
- Protocol file
Editorial Notes
18/03/2026: Study’s existence confirmed by the Lokman Hekim University Scientific Research Ethics Committee, Turkey.
