Turkish Adaptation of the Pediatric Quality of Recovery Scale (PedSQoR-T)

NCT07527546 | Not Yet Recruiting

• 1 other identifier: ctf- PEDsQoR -05
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Anesthesia; Pediatric Postoperative Recovery; Pediatric Enhanced Recovery After Surgery

Keywords

Pediatric Quality of Recovery Scale; Validity; PedSQoR

Outcome Measures

Primary Outcomes (1)

• Construct validity of the Turkish version of the Pediatric Quality of Recovery Scale

  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.

  Within the first 24 postoperative hours

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Other: Observational exposure

Interventions

Observational exposure OTHER

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.

Pediatric surgical patients undergoing elective surgery under general anesthesia

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing elective outpatient or inpatient surgery under general anesthesia at three tertiary care hospitals in Turkey, together with their parents or legal guardians, from whom postoperative recovery data will be collected.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Bakırköy, Istanbul, 34153, Turkey (Türkiye)

Location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (1)

• Graydon C, Stricker PA, Kelleher S, Cravero J, Karim N, Muhly WT, Lee-Archer P. Development of the Pediatric Scale for Quality of Recovery (PedSQoR). Anesthesiology. 2025 Aug 1;143(2):275-286. doi: 10.1097/ALN.0000000000005503. Epub 2025 Apr 14.

  PMID: 40227959 BACKGROUND

Study Officials

• münevver kayhan, Lecturer Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  PRINCIPAL INVESTIGATOR

• Ayse Cigdem Tutuncu

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

• Gülsen Keskin

  Ankara Etlik City Hospital

  STUDY CHAIR

Central Study Contacts

münevver kayhan, Lecturer Doctor

CONTACT

02124143000; munevver.kayhan@iuc.edu.tr

Ayse Cigdem Tutuncu, Professor Doctor

CONTACT

02124143000; actutuncu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 14, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 25, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)