Preoperative AnxietyNCT07368387
QR Code-Based Preoperative Education for Cesarean Birth: Anxiety, Pain, and Comfort
A study testing QR Code-Based Preoperative Education in people with Preoperative Anxiety and Postpartum Pain, run by Karabuk University.
Trial summary
This study aims to evaluate the effect of QR code-based preoperative education on anxiety, postpartum pain, and comfort levels in women undergoing cesarean birth. Cesarean delivery is a common surgical procedure, and insufficient preoperative information may increase anxiety and negatively affect postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Postpartum Pain, Maternal Comfort
- What is being tested?
- QR Code-Based Preoperative Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 18 years or older
- Scheduled for elective (planned) cesarean birth
- Able to read and understand Turkish and complete study questionnaires
- Able to provide written informed consent
- Has access to a smartphone and is able to use a QR code to view the educational materials (intervention arm)
Who cannot join
- Emergency cesarean birth or unplanned change to emergency surgery
- Presence of high-risk pregnancy or serious obstetric/medical complications requiring intensive management (e.g., severe preeclampsia/eclampsia, major hemorrhage risk, unstable systemic disease)
- Known psychiatric disorder or current use of medications that may substantially affect anxiety assessment (as judged by the clinical team)
- Communication barriers that prevent participation (e.g., severe visual/hearing impairment, cognitive impairment) or inability to complete questionnaires
- No smartphone access or inability/unwillingness to use QR code materials (for intervention delivery)
- Refusal to participate or withdrawal of consent at any time
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of QR Code-Based Preoperative Education on Anxiety, Postpartum Pain, and Comfort in Women Undergoing Cesarean Birth
This study aims to evaluate the effect of QR code-based preoperative education on anxiety, postpartum pain, and comfort levels in women undergoing cesarean birth. Cesarean delivery is a common surgical procedure, and insufficient preoperative information may increase anxiety and negatively affect postoperative recovery and comfort.
In this randomized controlled study, eligible pregnant women scheduled for elective cesarean birth will be assigned to either an intervention group or a control group. Women in the intervention group will receive preoperative education delivered through QR code-based digital materials, including information about the cesarean procedure, postoperative pain management, and comfort-enhancing strategies. The control group will receive routine care provided by the hospital.
Anxiety levels will be assessed preoperatively, while postpartum pain and comfort levels will be evaluated after delivery using validated measurement tools. The findings of this study are expected to contribute to the development of accessible and effective educational interventions to improve maternal well-being and postoperative outcomes in cesarean birth.
Read the detailed description
This study is designed as a randomized controlled trial to examine the effects of QR code-based preoperative education on anxiety, postpartum pain, and comfort among women undergoing elective cesarean birth. The study will be conducted in a hospital setting and will include pregnant women who meet the predefined inclusion criteria and provide informed consent.
Participants will be randomly allocated into two groups: an intervention group and a control group. Randomization will be performed using a predetermined allocation method to ensure comparability between groups. Women assigned to the intervention group will receive structured preoperative education delivered through QR code-based digital materials. These materials will include information on the cesarean birth process, perioperative expectations, postoperative pain management, and strategies to enhance physical and psychological comfort. Participants will be able to access the educational content using their personal mobile devices prior to surgery. The control group will receive routine preoperative care and standard information provided by the hospital.
Data collection will be carried out at multiple time points. Preoperative anxiety levels will be assessed prior to the cesarean procedure. Postpartum pain and comfort levels will be evaluated after delivery during the postoperative period. Validated measurement instruments will be used to collect outcome data. Sociodemographic and obstetric characteristics will also be recorded to describe the study population and to control for potential confounding variables.
The primary outcomes of the study are changes in preoperative anxiety and postoperative pain and comfort levels. The study does not involve the use of any pharmacological agents or medical devices and poses minimal risk to participants. The results are expected to provide evidence on the effectiveness of digital, easily accessible educational interventions in improving maternal outcomes in cesarean birth.
- Being tested
- QR Code-Based Preoperative Education
- Keywords
- Cesarean Birth, Preoperative Education, QR Code-Based Education, Maternal Anxiety, Postpartum Pain, Maternal Comfort, Digital Health Education, Randomized Controlled Trial, Prenatal Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QR Code-Based Preoperative EducationBehavioural
Educational intervention delivered via QR code-based digital materials providing preoperative information on cesarean birth, postoperative pain management, and comfort strategies.
| Study group | Role | What they receive |
|---|---|---|
| QR Code-Based Preoperative Education | Experimental | Participants in this arm will receive structured preoperative education delivered through QR code-based digital materials prior to elective cesarean birth. The educational content will include information about the cesarean procedure, perioperative expectations, postoperative pain management, and comfort-enhancing strategies. Receives: Behavioral: QR Code-Based Preoperative Education |
| Control | No intervention | Participants in this arm will receive routine preoperative care and standard information provided by the hospital without access to the QR code-based educational materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Pain Level
Postpartum pain levels will be evaluated to determine the effect of QR code-based preoperative education on pain experienced after cesarean birth. Pain will be assessed using a validated pain assessment tool.
Measured: Postpartum period following cesarean birth
Preoperative Anxiety Level
Preoperative anxiety will be assessed to evaluate the effect of QR code-based preoperative education on anxiety levels in women undergoing elective cesarean birth. Anxiety will be measured using a validated self-report instrument.
Measured: Preoperatively, prior to cesarean birth
Secondary outcomes (1)
Maternal Comfort Level
Maternal comfort will be assessed to examine the effect of QR code-based preoperative education on physical and psychological comfort after cesarean birth. Comfort levels will be measured using a validated comfort assessment scale.
Measured: Postpartum period following cesarean birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion25 Mar 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: an intervention group receiving QR code-based preoperative education and a control group receiving routine preoperative care. Each participant will be exposed to only one study condition throughout the trial.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Aydin Doğan, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368387
- Sponsor's protocol ID
- 2023/1494
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves sensitive personal and health-related information collected within a single-center, thesis-based research project. Data confidentiality and participant privacy will be strictly protected in accordance with ethical approval and institutional policies. De-identified, aggregate results will be reported in publications.
Publications
Togac HK, Yilmaz E. Effects of preoperative individualized audiovisual education on anxiety and comfort in patients undergoing laparoscopic cholecystectomy: randomised controlled study. Patient Educ Couns. 2021 Mar;104(3):603-610. doi: 10.1016/j.pec.2020.08.026. Epub 2020 Aug 28.
PubMed 32933794Mostafayi M, Imani B, Zandi S, Jongi F. The effect of familiarization with preoperative care on anxiety and vital signs in the patient's cesarean section: A randomized controlled trial. Eur J Midwifery. 2021 Jun 25;5:21. doi: 10.18332/ejm/137366. eCollection 2021.
PubMed 34222839Abuzaid M, Alshahrani MS, Ahmed AM, Moafa MN, Alomar O, O'Mahony A, Abu-Zaid A. Effectiveness of preoperative multimedia educational sessions on the levels of anxiety and satisfaction among women undergoing cesarean: a systematic review and meta-analysis. Women Health. 2024 May-Jun;64(5):416-426. doi: 10.1080/03630242.2024.2349560. Epub 2024 May 5.
PubMed 38706246
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of QR Code-Based Preoperative Education on Anxiety, Postpartum Pain, and Comfort in Women Undergoing Cesarean Birth
- ClinicalTrials.gov ID
- NCT07368387
- Acronym / sponsor ID
- 2023/1494
- Keywords
- Cesarean Birth, Preoperative Education, QR Code-Based Education, Maternal Anxiety, Postpartum Pain, Maternal Comfort, Digital Health Education, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 26 Jan 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 aims to evaluate the effect of QR code-based preoperative education on anxiety, postpartum pain, and comfort levels in women undergoing cesarean birth. Cesarean delivery is a common surgical procedure, and insufficient preoperative information may increase anxiety and negatively affect postoperative recovery and comfort.
In this randomized controlled study, eligible pregnant women scheduled for elective cesarean birth will be assigned to either an intervention group or a control group. Women in the intervention group will receive preoperative education delivered through QR code-based digital materials, including information about the cesarean procedure, postoperative pain management, and comfort-enhancing strategies. The control group will receive routine care provided by the hospital.
Anxiety levels will be assessed preoperatively, while postpartum pain and comfort levels will be evaluated after delivery using validated measurement tools. The findings of this study are expected to contribute to the development of accessible and effective educational interventions to improve maternal well-being and postoperative outcomes in cesarean birth.
Detailed description
This study is designed as a randomized controlled trial to examine the effects of QR code-based preoperative education on anxiety, postpartum pain, and comfort among women undergoing elective cesarean birth. The study will be conducted in a hospital setting and will include pregnant women who meet the predefined inclusion criteria and provide informed consent.
Participants will be randomly allocated into two groups: an intervention group and a control group. Randomization will be performed using a predetermined allocation method to ensure comparability between groups. Women assigned to the intervention group will receive structured preoperative education delivered through QR code-based digital materials. These materials will include information on the cesarean birth process, perioperative expectations, postoperative pain management, and strategies to enhance physical and psychological comfort. Participants will be able to access the educational content using their personal mobile devices prior to surgery. The control group will receive routine preoperative care and standard information provided by the hospital.
Data collection will be carried out at multiple time points. Preoperative anxiety levels will be assessed prior to the cesarean procedure. Postpartum pain and comfort levels will be evaluated after delivery during the postoperative period. Validated measurement instruments will be used to collect outcome data. Sociodemographic and obstetric characteristics will also be recorded to describe the study population and to control for potential confounding variables.
The primary outcomes of the study are changes in preoperative anxiety and postoperative pain and comfort levels. The study does not involve the use of any pharmacological agents or medical devices and poses minimal risk to participants. The results are expected to provide evidence on the effectiveness of digital, easily accessible educational interventions in improving maternal outcomes in cesarean birth.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: an intervention group receiving QR code-based preoperative education and a control group receiving routine preoperative care. Each participant will be exposed to only one study condition throughout the trial.
| Arm | Type | Receives |
|---|---|---|
| QR Code-Based Preoperative Education | Experimental | Behavioral: QR Code-Based Preoperative EducationParticipants in this arm will receive structured preoperative education delivered through QR code-based digital materials prior to elective cesarean birth. The educational content will include information about the cesarean procedure, perioperative expectations, postoperative pain management, and comfort-enhancing strategies. |
| Control | No intervention | –Participants in this arm will receive routine preoperative care and standard information provided by the hospital without access to the QR code-based educational materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women aged 18 years or older
- Scheduled for elective (planned) cesarean birth
- Able to read and understand Turkish and complete study questionnaires
- Able to provide written informed consent
- Has access to a smartphone and is able to use a QR code to view the educational materials (intervention arm)
Key exclusion criteria (6 listed)
- Emergency cesarean birth or unplanned change to emergency surgery
- Presence of high-risk pregnancy or serious obstetric/medical complications requiring intensive management (e.g., severe preeclampsia/eclampsia, major hemorrhage risk, unstable systemic disease)
- Known psychiatric disorder or current use of medications that may substantially affect anxiety assessment (as judged by the clinical team)
- Communication barriers that prevent participation (e.g., severe visual/hearing impairment, cognitive impairment) or inability to complete questionnaires
- No smartphone access or inability/unwillingness to use QR code materials (for intervention delivery)
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 |
|---|---|---|
| QR Code-Based Preoperative EducationEducational intervention delivered via QR code-based digital materials providing preoperative information on cesarean birth, postoperative pain management, and comfort strategies. | Behavioural | QR Code-Based Preoperative Education |
Primary outcome
Postpartum Pain Level
Time frame: Postpartum period following cesarean birth
Postpartum pain levels will be evaluated to determine the effect of QR code-based preoperative education on pain experienced after cesarean birth. Pain will be assessed using a validated pain assessment tool.
Preoperative Anxiety Level
Time frame: Preoperatively, prior to cesarean birth
Preoperative anxiety will be assessed to evaluate the effect of QR code-based preoperative education on anxiety levels in women undergoing elective cesarean birth. Anxiety will be measured using a validated self-report instrument.
1 secondary outcome
Maternal Comfort Level
Time frame: Postpartum period following cesarean birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 32933794Togac HK, Yilmaz E. Effects of preoperative individualized audiovisual education on anxiety and comfort in patients undergoing laparoscopic cholecystectomy: randomised controlled study. Patient Educ Couns. 2021 Mar;104(3):603-610. doi: 10.1016/j.pec.2020.08.026. Epub 2020 Aug 28.
- Background: PubMed 34222839Mostafayi M, Imani B, Zandi S, Jongi F. The effect of familiarization with preoperative care on anxiety and vital signs in the patient's cesarean section: A randomized controlled trial. Eur J Midwifery. 2021 Jun 25;5:21. doi: 10.18332/ejm/137366. eCollection 2021.
- Background: PubMed 38706246Abuzaid M, Alshahrani MS, Ahmed AM, Moafa MN, Alomar O, O'Mahony A, Abu-Zaid A. Effectiveness of preoperative multimedia educational sessions on the levels of anxiety and satisfaction among women undergoing cesarean: a systematic review and meta-analysis. Women Health. 2024 May-Jun;64(5):416-426. doi: 10.1080/03630242.2024.2349560. Epub 2024 May 5.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves sensitive personal and health-related information collected within a single-center, thesis-based research project. Data confidentiality and participant privacy will be strictly protected in accordance with ethical approval and institutional policies. De-identified, aggregate results will be reported in publications.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing QR Code-Based Preoperative Education in people with Preoperative Anxiety and Postpartum Pain, run by Karabuk University.
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 6 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reyhan Aydin Dogan, Associate Professor (+905422666568, reyhanaydin@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Pain Level (time frame: Postpartum period following cesarean birth). 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?
On the ClinicalTrials.gov record for NCT07368387, which also lists 3 linked publications.
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 26 Jan 2026.