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Pediatric AnesthesiaPedSQoR-TNCT07527546

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

An observational study of Pediatric Anesthesia and Pediatric Postoperative Recovery, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 years
What is being tested?
Observational exposure
How many people
300 participants
Where
2 sitesTurkey (Türkiye)
Study dates
10 Apr 2026to 25 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

münevver kayhan, Lecturer Doctor contact

02124143000

munevver.kayhan@iuc.edu.tr

Ayse Cigdem Tutuncu, Professor Doctor contact

02124143000

actutuncu@gmail.com

Turkey (Türkiye)2 sites

  • Ankara Etlik City Hospital

    Ankara, Yenimahalle, 06170

    Gülsen Keskin, Professor Doctor, +905334133524, drgulsenkeskin@gmail.com

    Gülsen Keskin, Professor Doctor

  • Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

    Bakırköy, Istanbul, 34153

    münevver kayhan, Lecturer Doctor, 02124143000, munevver.kayhan@iuc.edu.tr

    münevver kayhan, Lecturer Doctor

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Observational exposure
Keywords
Pediatric Quality of Recovery Scale, Validity, PedSQoR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational exposureOther

    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.

Study groups in NCT07527546
Study groupRoleWhat they receive
Pediatric surgical patients undergoing elective surgery under general anesthesiaChildren 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.
Receives: Other: Observational exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within the first 24 postoperative hours

Secondary outcomes (3)

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

    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.

    Measured: Within the first 24 postoperative hours

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

    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.

    Measured: Postoperative 24 hours and postoperative 2 weeks

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

    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.

    Measured: Within the first 24 postoperative hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start10 Apr 2026 (estimated)
  3. Primary completion10 Jul 2026 (estimated)
  4. Study completion25 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527546
Sponsor's protocol ID
ctf- PEDsQoR -05
Acronym
PedSQoR-T
Status last verified
Apr 2026
First submitted
31 Mar 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40227959

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Anesthesia and Pediatric Postoperative Recovery, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact münevver kayhan, Lecturer Doctor (02124143000, munevver.kayhan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Construct validity of the Turkish version of the Pediatric Quality of Recovery Scale (time frame: Within the first 24 postoperative hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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