Cesarean BirthNCT07467304
Nursing Education Provided After Cesarean Section Surgery.
A study testing Experimental: Experimental: Intervention group - Training group in people with Cesarean Birth and Patient Education, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of individual education given after cesarean section on the levels of pain and anxiety in women in the postoperative period. The research is a randomized controlled trial with an experimental design, featuring a pre-test-post-test control design with experimental and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Birth, Patient Education
- What is being tested?
- Experimental: Experimental: Intervention group - Training group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 30 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45
- Women who have undergone cesarean section
- Women who agreed to participate in the study
Who cannot join
- Women who are not between 18 and 45 years of age
- Women who have not had a cesarean section
- Those who did not agree to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tekirdag Namık Kemal University
Tekirdağ, Namık Kemal Street, 59030
About this study
Official title: The Effect Of Nursing Education Provided After Cesarean Section Surgery on Postoperative Pain and Anxiety Levels: A Randomized Controlled Trial
The aim of this study is to determine the effect of individual education given after cesarean section on the levels of pain and anxiety in women in the postoperative period. The research is a randomized controlled trial with an experimental design, featuring a pre-test-post-test control design with experimental and control groups. The study will be conducted at Çorlu State Hospital. Data will be collected by conducting a pre-test within the first 6-12 hours after cesarean section, followed by education, and then a post-test before discharge (24-48 hours later). The Demographic Information Form, Knowledge Test, Spielberger State-Trait Anxiety Inventory, and Visual Analog Scale will be used to collect data.
- Conditions
- Cesarean Birth, Patient Education
- Being tested
- Experimental: Experimental: Intervention group - Training group, Placebo Comparator: Control Group- Routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Experimental: Intervention group - Training groupOther
Group receiving routine care and nursing training.
Placebo Comparator: Control Group- Routine careOther
Rutin care group
| Study group | Role | What they receive |
|---|---|---|
| Control Group- Routine care | Placebo comparator | Rutin care group Receives: Other: Placebo Comparator: Control Group- Routine care |
| Experimental: Intervention group - Training group | Experimental | Group receiving routine care and nursing training. Receives: Other: Experimental: Experimental: Intervention group - Training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State-Trait Anxiety Inventory (STAI):
Spielberger State-Trait Anxiety Inventory (STAI): The state anxiety inventory determines how a person feels at a specific time. The scale is answered on a scale of "1 (none), 2 (somewhat), 3 (a lot), 4 (completely)" according to the intensity of the individual's feelings at that moment. The trait anxiety inventory, on the other hand, determines how the individual generally feels and is answered on a scale of "1 (almost never), 2 (sometimes), 3 (most of the time), 4 (always)". The state anxiety scale has 10 reverse items, and the trait anxiety scale has 7 reverse items. To calculate the scale score, the total score obtained from the direct items is subtracted from the total score obtained from the reverse items. A constant value of 50 for the state anxiety scale and 35 for the trait anxiety scale is added to the resulting number. The possible score ranges from 20 to 80. The average score is between 36 and 41. As the score increases, the level of anxiety also increases.
Measured: 12 weeks
Secondary outcomes (1)
Visual Analog Scale (VAS)
The VAS is used to convert certain values that cannot be measured quantitatively into numerical values. It is a 10 cm scale with pain-free resolution at one end and the most severe pain possible at the other. In the VAS, which evaluates pain intensity, pain intensity is rated on a scale of 0 to 10. "No pain" is rated as 0 points and "very severe pain" is rated as 10 points. Pain intensity is indicated as "less than 3 points" for mild pain, "between 3-6 points" for moderate pain, and "more than 6 points" for severe pain.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Dec 2025
- Primary completion15 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean BirthStudies 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
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Erden, Namik Kemal University
- Investigators
- DİLEK ERDEN, Principal investigator, Namik Kemal UniversityEsra Yılmaz, Master's student, Study chair, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467304
- Sponsor's protocol ID
- DERDEN-5
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data obtained from the study may be requested from researchers for a reasonable reason.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Nursing Education Provided After Cesarean Section Surgery on Postoperative Pain and Anxiety Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07467304
- Acronym / sponsor ID
- DERDEN-5
- Conditions
- Cesarean Birth, Patient Education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Mar 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.
The aim of this study is to determine the effect of individual education given after cesarean section on the levels of pain and anxiety in women in the postoperative period. The research is a randomized controlled trial with an experimental design, featuring a pre-test-post-test control design with experimental and control groups. The study will be conducted at Çorlu State Hospital. Data will be collected by conducting a pre-test within the first 6-12 hours after cesarean section, followed by education, and then a post-test before discharge (24-48 hours later). The Demographic Information Form, Knowledge Test, Spielberger State-Trait Anxiety Inventory, and Visual Analog Scale will be used to collect data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group- Routine care | Placebo comparator | Other: Placebo Comparator: Control Group- Routine careRutin care group |
| Experimental: Intervention group - Training group | Experimental | Other: Experimental: Experimental: Intervention group - Training groupGroup receiving routine care and nursing training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-45
- Women who have undergone cesarean section
- Women who agreed to participate in the study
Key exclusion criteria (3 listed)
- Women who are not between 18 and 45 years of age
- Women who have not had a cesarean section
- Those who did not agree to participate in the study
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 |
|---|---|---|
| Experimental: Experimental: Intervention group - Training groupGroup receiving routine care and nursing training. | Other | Experimental: Intervention group - Training group |
| Placebo Comparator: Control Group- Routine careRutin care group | Other | Control Group- Routine care |
Primary outcome
Spielberger State-Trait Anxiety Inventory (STAI):
Time frame: 12 weeks
Spielberger State-Trait Anxiety Inventory (STAI): The state anxiety inventory determines how a person feels at a specific time. The scale is answered on a scale of "1 (none), 2 (somewhat), 3 (a lot), 4 (completely)" according to the intensity of the individual's feelings at that moment. The trait anxiety inventory, on the other hand, determines how the individual generally feels and is answered on a scale of "1 (almost never), 2 (sometimes), 3 (most of the time), 4 (always)". The state anxiety scale has 10 reverse items, and the trait anxiety scale has 7 reverse items. To calculate the scale score, the total score obtained from the direct items is subtracted from the total score obtained from the reverse items. A constant value of 50 for the state anxiety scale and 35 for the trait anxiety scale is added to the resulting number. The possible score ranges from 20 to 80. The average score is between 36 and 41. As the score increases, the level of anxiety also increases.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: 12 weeks
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 12 Mar 2026.
- Individual participant dataSharing planned: No. Data obtained from the study may be requested from researchers for a reasonable reason.
Related trials for Cesarean Birth
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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.
DİLEK ERDEN principal investigator
Namik Kemal University
Esra Yılmaz, Master's student study chair
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Experimental: Intervention group - Training group in people with Cesarean Birth and Patient Education, run by Namik Kemal 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 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. Some participants in this study may receive a placebo. 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?
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?
Spielberger State-Trait Anxiety Inventory (STAI): (time frame: 12 weeks). 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 12 Mar 2026.