NCT07467304

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Dec 2025Jun 2026

Study Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Visual Analog Scale (VAS)

    12 weeks

Study Arms (2)

Control Group- Routine care

PLACEBO COMPARATOR

Rutin care group

Other: Placebo Comparator: Control Group- Routine care

Experimental: Intervention group - Training group

EXPERIMENTAL

Group receiving routine care and nursing training.

Other: Experimental: Experimental: Intervention group - Training group

Interventions

Group receiving routine care and nursing training.

Experimental: Intervention group - Training group

Rutin care group

Control Group- Routine care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen were included in the study because they had undergone cesarean section surgery.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-45
  • Women who have undergone cesarean section
  • Women who agreed to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, Namık Kemal Street, 59030, Turkey (Türkiye)

Location

Study Officials

  • DİLEK ERDEN

    Namik Kemal University

    PRINCIPAL INVESTIGATOR
  • Esra Yılmaz, Master's student

    Namik Kemal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Dr.)

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

December 1, 2025

Primary Completion

May 15, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data obtained from the study may be requested from researchers for a reasonable reason.

Locations