- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467304
Nursing Education Provided After Cesarean Section Surgery.
March 9, 2026 updated by: Dilek Erden, Namik Kemal University
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Namık Kemal Street
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Tekirdağ, Namık Kemal Street, Turkey (Türkiye), 59030
- Tekirdag Namık Kemal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women aged 18-45
- Women who have undergone cesarean section
- Women who agreed to participate in the study
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control Group- Routine care
Rutin care group
|
Rutin care group
|
|
Experimental: Experimental: Intervention group - Training group
Group receiving routine care and nursing training.
|
Group receiving routine care and nursing training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DİLEK ERDEN, Namik Kemal University
- Study Chair: Esra Yılmaz, Master's student, Namik Kemal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- DERDEN-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data obtained from the study may be requested from researchers for a reasonable reason.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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