Postoperative Recovery(QoR-15Gr)NCT06699823
Validation of the Greek Postoperative Quality of Recovery Score 15
An observational study of Postoperative Recovery and Quality of Recovery From Anaesthesia, run by IASO Thessalias at 1 site in Greece.
Trial summary
The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Recovery, Quality of Recovery From Anaesthesia, PROMs
- What is being tested?
- Greek version of QoR-15
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2024to 28 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will take place in IASO Thessalias General Hospital (the largest private general hospital in the region of Thessaly in Greece).
Who may be able to join
- Age>18 years old
- Scheduled elective general surgery under general anesthesia
Who cannot join
- Emergency surgery
- Poor Greek comprehension
- Inability to give consent
- A psychiatric or neurological condition that precludes cooperation
- Known history of alcohol or drug dependence
- Life-threatening postoperative complications
- Postoperative admission to ITU
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
IASO Thessalias General Hospital
Larissa, Thessaly, 41005
DESPOINA LIOTIRI, ANAESTHESIOLOGIST, 00306947941422, deppieliotiri@gmail.com
DESPOINA LIOTIRI, ANAESTHESIOLOGIST
About this study
Official title: Cultural Adaptation and Validation of the Greek Version of the Postoperative Quality of Recovery Score 15 (QoR-15Gr)
The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.
Read the detailed description
This study aims to culturally adapt and validate a Greek version of the Quality of Recovery - 15 (QoR-15), referred to as the QoR-15Gr, for Greek-speaking surgical patients. The investigators hypothesize that the QoR-15Gr will demonstrate psychometric properties comparable to the original English version.
- Conditions
- Postoperative Recovery, Quality of Recovery From Anaesthesia, PROMs, Validation Study, Cultural Adaptation
- Being tested
- Greek version of QoR-15
- Keywords
- quality of recovery, patient reported outcomes, QoR-15, validation, cultural adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greek version of QoR-15Other
Greek version of QoR-15
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation and cultural adaptation of the Greek version of the postoperative quality of recovery score 15 (QoR-15Gr)
The QoR-15 consists of 15 questions and the patients are asked to rate various aspects of their postoperative recovery from 0 to 10. Minimum score is 0 and corresponds to the worst score. Maximum score is 150 and corresponds to optimal recovery.
Translation into Greek and pilot test will be performed.
Measured: From enrollment until 20 first patient have been enrolled
Psychometric properties of postoperative quality of recovery 15 (QoR-15Gr) will be assessed by evaluating validity (convergent, construct, and discriminant), reliability (internal consistency and repeatability), and responsiveness.
Measured: From enrollment until 150 patients have been enrolled
Acceptability and feasibility of the postoperative quality of recovery 15 (QoR-15Gr) will be assessed by measuring patient recruitment rate as well as successful recruitment rate.
Measured: From enrollment until 150 patients have been enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IASO Thessalias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DESPOINA LIOTIRI, IASO Thessalias
- Investigators
- DESPOINA LIOTIRI, ANAESTHESIOLOGIST, Principal investigator, IASO THESSALIAS GENERAL HOSPITALDIMITRIOS ZACHAROULIS, PROFESSOR OF SURGERY, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699823
- Sponsor's protocol ID
- 785
- Acronym
- (QoR-15Gr)
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Validation of the Greek Version of the Postoperative Quality of Recovery Score 15 (QoR-15Gr)
- ClinicalTrials.gov ID
- NCT06699823
- Acronym / sponsor ID
- (QoR-15Gr) / 785
- Conditions
- Postoperative Recovery, Quality of Recovery From Anaesthesia, PROMs, Validation Study, Cultural Adaptation
- Keywords
- quality of recovery, patient reported outcomes, QoR-15, validation, cultural adaptation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IASO ThessaliasUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 21 Nov 2024 (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.
The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.
Detailed description
This study aims to culturally adapt and validate a Greek version of the Quality of Recovery - 15 (QoR-15), referred to as the QoR-15Gr, for Greek-speaking surgical patients. The investigators hypothesize that the QoR-15Gr will demonstrate psychometric properties comparable to the original English version.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will take place in IASO Thessalias General Hospital (the largest private general hospital in the region of Thessaly in Greece).
Key inclusion criteria (2 listed)
- Age>18 years old
- Scheduled elective general surgery under general anesthesia
Key exclusion criteria (7 listed)
- Emergency surgery
- Poor Greek comprehension
- Inability to give consent
- A psychiatric or neurological condition that precludes cooperation
- Known history of alcohol or drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greek version of QoR-15Greek version of QoR-15 | Other | – |
Primary outcome
Translation and cultural adaptation of the Greek version of the postoperative quality of recovery score 15 (QoR-15Gr)
Time frame: From enrollment until 20 first patient have been enrolled
The QoR-15 consists of 15 questions and the patients are asked to rate various aspects of their postoperative recovery from 0 to 10. Minimum score is 0 and corresponds to the worst score. Maximum score is 150 and corresponds to optimal recovery. Translation into Greek and pilot test will be performed.
Psychometric properties of postoperative quality of recovery 15 (QoR-15Gr) will be assessed by evaluating validity (convergent, construct, and discriminant), reliability (internal consistency and repeatability), and responsiveness.
Time frame: From enrollment until 150 patients have been enrolled
Acceptability and feasibility of the postoperative quality of recovery 15 (QoR-15Gr) will be assessed by measuring patient recruitment rate as well as successful recruitment rate.
Time frame: From enrollment until 150 patients have been enrolled
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 26 Nov 2024.
- Individual participant dataSharing planned: No
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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.
DESPOINA LIOTIRI, ANAESTHESIOLOGIST principal investigator
IASO THESSALIAS GENERAL HOSPITAL
DIMITRIOS ZACHAROULIS, PROFESSOR OF SURGERY study chair
University of Thessaly
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 and Quality of Recovery From Anaesthesia, run by IASO Thessalias at 1 site in Greece.
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 7 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 26 Nov 2024. 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 Greece. 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 DESPOINA LIOTIRI, ANAESTHESIOLOGIST (00306947941422, deppieliotiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation and cultural adaptation of the Greek version of the postoperative quality of recovery score 15 (QoR-15Gr) (time frame: From enrollment until 20 first patient have been enrolled). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.