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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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