Postoperative Recovery in ChildrenThai-PedsQoRNCT07378501
Thai Version of the Pediatric Quality of Recovery Score (PedSQoR): Translation and Psychometric Validation Study
An observational study of Postoperative Recovery in Children, run by Mahidol University at 1 site in Thailand.
Trial summary
Postoperative recovery in children is a complex, multidimensional process that differs substantially from recovery in adults, encompassing physical comfort, emotional well-being, behavioral changes, and psychosocial functioning. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Postoperative Recovery in Children
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- 5 May 2026to 30 Jun 2027
- How long will I take part?
- 21 Days
- 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: The study population includes pediatric patients undergoing surgical procedures who are assessed for postoperative recovery using the Thai Pediatric Quality of Recovery questionnaire (Thai-PedsQoR). Depending on the child's age and developmental ability, the questionnaire is completed either by the child (self-report) or by a parent or primary caregiver (proxy-report). Expert participants involved in content validity assessment include healthcare professionals with expertise in pediatric perioperative care and patient-reported outcome measurement.
Who may be able to join
- Pediatric patients aged 2-17 years undergoing day surgery/intervention or surgery/intervention requiring postoperative hospital admission.
- ASA Physical Status I-III.
Who cannot join
- Patients or parents/guardians who are unable to communicate in Thai.
- Urgent or emergent surgery.
- Children with significant developmental delay or severe systemic disease that interferes with activities of daily living.
- Parents, guardians, or patients who, in the opinion of the investigator, are unlikely to be available to complete follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Issada Jindawatthana, +66624196194, issada.j@gmail.com
About this study
Official title: Translation and Psychometric Validation of the Thai Version of the Pediatric Quality of Recovery Score (Thai-PedsQoR)
Postoperative recovery in children is a complex, multidimensional process that differs substantially from recovery in adults, encompassing physical comfort, emotional well-being, behavioral changes, and psychosocial functioning. While several validated Quality of Recovery (QoR) instruments are widely used in adult perioperative care, equivalent tools for pediatric populations remain limited, particularly in non-English-speaking settings. The Pediatric Quality of Recovery score (PedSQoR) was recently developed to address this gap by providing a comprehensive, patient- and proxy-reported outcome measure specifically designed for children. However, a culturally adapted and psychometrically validated Thai version of this instrument is currently unavailable.
The primary objective of this study is to translate and culturally adapt the PedSQoR into Thai in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for patient-reported outcome measures. The secondary objective is to evaluate the psychometric properties of the Thai-PedSQoR, including content validity, construct validity, reliability, and responsiveness, in Thai pediatric surgical patients.
Read more
This clinical applied research will be conducted at Siriraj Hospital and will include children aged 2-17 years undergoing elective surgery or procedures requiring anesthesia. The translation process will involve forward and backward translation, expert committee review, and cognitive debriefing with parents and children to ensure conceptual equivalence and cultural appropriateness. Psychometric validation will be performed in a cohort of 130 participants, stratified into proxy-report and self-report groups according to age. The Thai-PedSQoR will be administered on postoperative days 2, 6, and 21, alongside anchor measures including pain and global recovery visual analog scales.
The expected outcome of this study is a reliable and valid Thai version of the PedSQoR that can be used in clinical practice, quality improvement initiatives, and future pediatric perioperative research, supporting patient-centered and value-based pediatric surgical care in Thailand.
- Conditions
- Postoperative Recovery in Children
- Keywords
- Pediatric anesthesia, Postoperative recovery, Patient-reported outcomes, Questionnaire validation, Psychometric validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients undergoing surgery | Pediatric patients undergoing surgery who complete the Thai-PedsQoR questionnaire, either by self-report or proxy-report. No intervention or group comparison is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Completion of the translation and cultural adaptation process of the Pediatric Quality of Recovery Questionnaire (PedSQoR) into Thai, following the ISPOR guidelines. Successful adaptation is defined as finalized Thai-PedsQoR wording approved by forward translation, backward translation, expert review, and cognitive debriefing, with no unresolved major issues identified.
Measured: With in 2 months after IRB approval
Secondary outcomes (5)
Internal Consistency of the Thai-PedsQoR
Internal consistency will be evaluated using Cronbach's alpha coefficient, which ranges from 0 to 1, with higher values indicating better internal consistency of the questionnaire items.
Measured: From initial questionnaire administration to repeat assessment within 21 days
Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Responsiveness will be assessed by changes in Thai-PedsQoR total scores over time following surgery, with higher scores indicating greater levels of the measured attributes as reported, reflecting changes in postoperative recovery trajectories in pediatric patients..
Measured: From initial questionnaire administration to repeat assessment within 21 days
Item-Level Content Validity Index (I-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Item-level Content Validity Index (I-CVI) calculated as the proportion of experts rating each item of the Thai-PedsQoR as relevant (rating of 3 or 4 on a 4-point relevance scale). I-CVI values range from 0 to 1, with higher values indicating greater item relevance.
Measured: Within 3 months after IRB approval
Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Scale-level Content Validity Index (S-CVI/Ave) calculated as the average of item-level content validity indices across all items of the Thai-PedsQoR. S-CVI values range from 0 to 1, with higher values indicating better overall content validity of the questionnaire.
Measured: Within 3 months after IRB approval
Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Content Validity Ratio (CVR) calculated using Lawshe's method based on expert ratings of item essentiality. CVR values range from -1 to +1, with higher values indicating greater expert agreement that an item is essential for assessing pediatric postoperative recovery.
Measured: Within 3 months after IRB approval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 May 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Recovery in ChildrenStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378501
- Sponsor's protocol ID
- Si 1069/2025
- Acronym
- Thai-PedsQoR
- Status last verified
- May 2026
- First submitted
- 7 Jan 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Psychometric Validation of the Thai Version of the Pediatric Quality of Recovery Score (Thai-PedsQoR)
- ClinicalTrials.gov ID
- NCT07378501
- Acronym / sponsor ID
- Thai-PedsQoR / Si 1069/2025
- Conditions
- Postoperative Recovery in Children
- Keywords
- Pediatric anesthesia, Postoperative recovery, Patient-reported outcomes, Questionnaire validation, Psychometric validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative recovery in children is a complex, multidimensional process that differs substantially from recovery in adults, encompassing physical comfort, emotional well-being, behavioral changes, and psychosocial functioning. While several validated Quality of Recovery (QoR) instruments are widely used in adult perioperative care, equivalent tools for pediatric populations remain limited, particularly in non-English-speaking settings. The Pediatric Quality of Recovery score (PedSQoR) was recently developed to address this gap by providing a comprehensive, patient- and proxy-reported outcome measure specifically designed for children. However, a culturally adapted and psychometrically validated Thai version of this instrument is currently unavailable.
The primary objective of this study is to translate and culturally adapt the PedSQoR into Thai in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for patient-reported outcome measures. The secondary objective is to evaluate the psychometric properties of the Thai-PedSQoR, including content validity, construct validity, reliability, and responsiveness, in Thai pediatric surgical patients.
This clinical applied research will be conducted at Siriraj Hospital and will include children aged 2-17 years undergoing elective surgery or procedures requiring anesthesia. The translation process will involve forward and backward translation, expert committee review, and cognitive debriefing with parents and children to ensure conceptual equivalence and cultural appropriateness. Psychometric validation will be performed in a cohort of 130 participants, stratified into proxy-report and self-report groups according to age. The Thai-PedSQoR will be administered on postoperative days 2, 6, and 21, alongside anchor measures including pain and global recovery visual analog scales.
The expected outcome of this study is a reliable and valid Thai version of the PedSQoR that can be used in clinical practice, quality improvement initiatives, and future pediatric perioperative research, supporting patient-centered and value-based pediatric surgical care in Thailand.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 21 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients undergoing surgery | – | –Pediatric patients undergoing surgery who complete the Thai-PedsQoR questionnaire, either by self-report or proxy-report. No intervention or group comparison is performed. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes pediatric patients undergoing surgical procedures who are assessed for postoperative recovery using the Thai Pediatric Quality of Recovery questionnaire (Thai-PedsQoR). Depending on the child's age and developmental ability, the questionnaire is completed either by the child (self-report) or by a parent or primary caregiver (proxy-report). Expert participants involved in content validity assessment include healthcare professionals with expertise in pediatric perioperative care and patient-reported outcome measurement.
Key inclusion criteria (2 listed)
- Pediatric patients aged 2-17 years undergoing day surgery/intervention or surgery/intervention requiring postoperative hospital admission.
- ASA Physical Status I-III.
Key exclusion criteria (4 listed)
- Patients or parents/guardians who are unable to communicate in Thai.
- Urgent or emergent surgery.
- Children with significant developmental delay or severe systemic disease that interferes with activities of daily living.
- Parents, guardians, or patients who, in the opinion of the investigator, are unlikely to be available to complete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time frame: With in 2 months after IRB approval
Completion of the translation and cultural adaptation process of the Pediatric Quality of Recovery Questionnaire (PedSQoR) into Thai, following the ISPOR guidelines. Successful adaptation is defined as finalized Thai-PedsQoR wording approved by forward translation, backward translation, expert review, and cognitive debriefing, with no unresolved major issues identified.
5 secondary outcomes
Internal Consistency of the Thai-PedsQoR
Time frame: From initial questionnaire administration to repeat assessment within 21 days
Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time frame: From initial questionnaire administration to repeat assessment within 21 days
Item-Level Content Validity Index (I-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time frame: Within 3 months after IRB approval
Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time frame: Within 3 months after IRB approval
Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time frame: Within 3 months after IRB approval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 40227959Graydon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Recovery in Children, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 Issada Jindawatthana, Pediatric Anesthesiologist (+61431908917, issada.j@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR) (time frame: With in 2 months after IRB approval). 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 NCT07378501, 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 19 May 2026.