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临床试验/NCT07368387
NCT07368387尚未招募不适用

The Effect of QR Code-Based Preoperative Education on Anxiety, Postpartum Pain, and Comfort in Women Undergoing Cesarean Birth

Karabuk University0 个研究点目标入组 88 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
主要终点
Postpartum Pain Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: QR Code-Based Preoperative Education (Behavioral)

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.

结局指标

主要结局

Postpartum Pain Level

时间窗: 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

时间窗: 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.

次要结局

  • Maternal Comfort Level(Postpartum period following cesarean birth)

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Reyhan Aydin Doğan

ASSOCIATE PROFESSOR

Karabuk University

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