NCT07368387

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

Keywords

Cesarean BirthPreoperative EducationQR Code-Based EducationMaternal AnxietyPostpartum PainMaternal ComfortDigital Health EducationRandomized Controlled TrialPrenatal Education

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Preoperatively, prior to cesarean birth

Secondary Outcomes (1)

  • Maternal Comfort Level

    Postpartum period following cesarean birth

Study Arms (2)

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.

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.

Interventions

Educational intervention delivered via QR code-based digital materials providing preoperative information on cesarean birth, postoperative pain management, and comfort strategies.

QR Code-Based Preoperative Education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32933794BACKGROUND
  • Mostafayi 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.

    PMID: 34222839BACKGROUND
  • Abuzaid 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.

    PMID: 38706246BACKGROUND

Central Study Contacts

Reyhan Aydin Dogan, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

February 2, 2026

Primary Completion

March 25, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.