Adaptation of the Pediatric Postoperative Quality of Recovery Scale to the Turkish Population (PedSQoR-T): A Validity and Reliability Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Construct validity of the Turkish version of the Pediatric Quality of Recovery Scale
研究概览
简要总结
This multicenter prospective observational study aims to culturally adapt the Pediatric Quality of Recovery Scale into Turkish and to evaluate the validity and reliability of the Turkish version in pediatric surgical patients. Children aged 2 to 17 years undergoing elective outpatient or inpatient surgery under general anesthesia will be included. Postoperative recovery will be assessed using the Turkish version of the Pediatric Quality of Recovery Scale and a 0 to 100 millimeter visual analog scale, with age-appropriate child self-report or parent-proxy report.
详细描述
This is a multicenter, prospective, observational methodological study designed to perform the Turkish cultural adaptation of the Pediatric Quality of Recovery Scale and to evaluate the validity and reliability of the Turkish version in pediatric surgical patients. The study will be conducted in tertiary care centers in Turkey among children aged 2 to 17 years undergoing elective outpatient surgery or surgery requiring postoperative hospitalization under general anesthesia. The cultural adaptation process will include forward translation, back translation, and expert review for content evaluation. Study instruments will include a personal information form, the Turkish version of the Pediatric Quality of Recovery Scale, and a 0 to 100 millimeter visual analog scale. For children aged 2 to 7 years, parent-proxy responses will be used, whereas children aged 8 years and older will provide self-reported responses. The scale and the global recovery perception assessment will be administered with reference to the participant's condition during the first 24 postoperative hours. Assessments will be performed at postoperative 24 hours and again at postoperative 2 weeks. Data will be collected by telephone for outpatient cases and by face-to-face interview for hospitalized patients. The study will evaluate construct validity, content validity, convergent validity, internal consistency, split-half reliability, and the relationship between assessments obtained at different time points.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 2 to 17 years undergoing outpatient surgery or surgery requiring postoperative hospitalization under general anesthesia
- •Patients with an American Society of Anesthesiologists physical status classification of I, II, or III
- •A parent or legal guardian who is the patient's primary caregiver; in cases where there are two parents or caregivers, one parent will complete the form for children aged 2 to 7 years, and for children aged 8 to 17 years, one parent together with the child will complete the form
- •Patients whose parent or legal guardian has provided informed consent and who have provided child assent, when applicable
排除标准
- •Patients, parents, or legal guardians who do not speak Turkish, or those with a medical history affecting comprehension or communication skills
- •Patients requiring emergency or urgent surgical intervention
- •Developmental delay or severe systemic disease affecting activities of daily living
- •Children using any medication that may affect the central nervous system
- •Parents, legal guardians, or patients who, in the opinion of the investigator, may be unavailable or unlikely to complete the study
- •Patients with severe visual or hearing impairment, or significant cognitive or developmental disorders
- •Patients undergoing surgery under regional anesthesia
- •Patients with severe psychiatric illness, severe anxiety disorders unresponsive to non-pharmacological interventions, or use of psychoactive medications
研究组 & 干预措施
Pediatric surgical patients undergoing elective surgery under general anesthesia
Children aged 2 to 17 years undergoing elective outpatient or inpatient surgery under general anesthesia, evaluated for the validity and reliability of the Turkish version of the Pediatric Postoperative Quality of Recovery Scale.
干预措施: Observational exposure (Other)
结局指标
主要结局
Construct validity of the Turkish version of the Pediatric Quality of Recovery Scale
时间窗: Within the first 24 postoperative hours
Comparative Fit Index (CFI) from confirmatory factor analysis of responses to the Turkish PEDSQoR collected within the first 24 postoperative hours. A CFI value above 0.95 in the CFA supports that the proposed factor structure of the Turkish PEDSQoR shows a good fit to the data.
次要结局
- Convergent validity of the Turkish version of the Pediatric Quality of Recovery Scale with the visual analog scale for global recovery perception(Within the first 24 postoperative hours)
- Temporal agreement between 24-hour and 2-week retrospective assessments of recovery during the first postoperative 24 hours(Postoperative 24 hours and postoperative 2 weeks)
- Internal consistency reliability of the Turkish version of the Pediatric Quality of Recovery Scale(Within the first 24 postoperative hours)
研究者
Münevver Kayhan
Lecturer
Istanbul University - Cerrahpasa