Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07527546

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty, Bakırköy, Istanbul, Turkey (Türkiye)

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Construct validity of the Turkish version of the Pediatric Quality of Recovery Scale

    Time frame: 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 outcomes

  1. Convergent validity of the Turkish version of the Pediatric Quality of Recovery Scale with the visual analog scale for global recovery perception

    Time frame: 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.

  2. Temporal agreement between 24-hour and 2-week retrospective assessments of recovery during the first postoperative 24 hours

    Time frame: 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.

  3. Internal consistency reliability of the Turkish version of the Pediatric Quality of Recovery Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse Cigdem Tutuncu, Professor Doctor

CONTACT

[email protected]

02124143000

münevver kayhan, Lecturer Doctor

CONTACT

[email protected]

02124143000

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Adaptation of the Pediatric Postoperative Quality of Recovery Scale to the Turkish Population (PedSQoR-T): A Validity and Reliability Study

Acronym: PedSQoR-T

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.