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

April 9, 2026 updated by: Münevver Kayhan, Istanbul University - Cerrahpasa

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ayse Cigdem Tutuncu, Professor Doctor
  • Phone Number: 02124143000
  • Email: actutuncu@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Bakırköy, Istanbul, Turkey (Türkiye), 34153
        • Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
        • Contact:
        • Principal Investigator:
          • münevver kayhan, Lecturer Doctor
        • Sub-Investigator:
          • Ayse Cigdem Tutuncu, Professor Doctor
        • Sub-Investigator:
          • Pinar kendigelen, Professor Doctor
        • Sub-Investigator:
          • ilayda bilgili altuntaş, Medical Doctor
        • Sub-Investigator:
          • nilgün eren çakaroğlu, Medical Doctor
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06170
        • Ankara Etlik City Hospital
        • Contact:
        • Sub-Investigator:
          • Gülsen Keskin, Professor Doctor
        • Sub-Investigator:
          • Aslı Dönmez, Professor Doctor
        • Sub-Investigator:
          • Nazmiye Çelik, Medical Doctor
        • Sub-Investigator:
          • Elif Şule Özdemir Sezgi, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 24 postoperative hours
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.
Postoperative 24 hours and postoperative 2 weeks
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.
Within the first 24 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Principal Investigator: münevver kayhan, Lecturer Doctor, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
  • Study Chair: Ayse Cigdem Tutuncu, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
  • Study Chair: Gülsen Keskin, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 25, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ctf- PEDsQoR -05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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