Pediatric Anesthesia, Pediatric Enhanced Recovery After Surgery, Pediatric Postoperative Recovery
Conditions
Keywords
Pediatric Quality of Recovery Scale, Validity, PedSQoR
Brief summary
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.
Detailed description
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.
Interventions
OTHERObservational exposure
This is an observational validation study in which postoperative recovery questionnaires are administered to children aged 2 to 17 years, or to their parents or caregivers when appropriate, after elective surgery under general anesthesia. The study aims to evaluate postoperative recovery and assess the validity and reliability of the Turkish version of the Pediatric Postoperative Quality of Recovery Scale. No intervention is assigned by the study protocol.
Sponsors
Istanbul University - Cerrahpasa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Construct validity of the Turkish version of the Pediatric Quality of Recovery Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Convergent validity will be assessed by examining the correlation between scores on the Turkish version of the Pediatric Quality of Recovery Scale, a 20-item, 5-point Likert-type instrument with total scores ranging from 20 to 100, where higher scores indicate better postoperative recovery, and child- or parent-reported scores on a 0 to 100 millimeter Visual Analog Scale for global recovery perception, where higher scores indicate better perceived recovery, referring to 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 | The Turkish version of the Pediatric Quality of Recovery Scale (total score range 20 to 100, with higher scores indicating better postoperative recovery) and the 0 to 100 millimeter Visual Analog Scale for global recovery perception (with higher scores indicating better perceived recovery) will be administered at postoperative 24 hours and again at postoperative 2 weeks, with both assessments referring to the participant's condition during the first postoperative 24 hours. Agreement between the two assessment time points and associations between the two instruments will be evaluated. |
| Internal consistency reliability of the Turkish version of the Pediatric Quality of Recovery Scale | Within the first 24 postoperative hours | Internal consistency reliability will be assessed using the Cronbach's alpha coefficient for the Turkish version of the Pediatric Quality of Recovery Scale. The primary reported value will be the total scale Cronbach's alpha coefficient. The scale is a 20-item, 5-point Likert-type instrument with total scores ranging from 20 to 100, with higher scores indicating better postoperative recovery. |
Countries
Turkey (Türkiye)
Contacts
CONTACTmünevver kayhan, Lecturer Doctor
CONTACTAyse Cigdem Tutuncu, Professor Doctor
PRINCIPAL_INVESTIGATORmünevver kayhan, Lecturer Doctor
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
STUDY_CHAIRAyse Cigdem Tutuncu
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
STUDY_CHAIRGülsen Keskin
Ankara Etlik City Hospital
Outcome results
None listed