to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15TNCT05124054
The Validity and Reliability of the Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire
An observational study of to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15T, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative recovery is a complex process influenced by various factors such as patients, surgical methods and anesthetic properties. Such factors can be accompanied by many negative situations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15T
- How many people
- 177 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2021to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18 and 65 who will undergo elective surgery and who is native Turkish speaker
Who may be able to join
- native turkish speaker
- scheduled elective surgery
Who cannot join
- with cognitive impairment,
- American Society of Anesthesiologists (ASA) physical condition IV or higher,
- patients with psychiatric disorders,
- history of alcohol or any other substance abuse
- patients expected to need postoperative mechanical ventilation (eg, cardiovascular surgery requiring cardiopulmonary bypass, microvascular reconstruction surgery for oral and maxillofacial cancer, etc.)
- Patients who are thought to be unable to answer the questionnaire due to a change in mental status or the need for sedation during the postoperative evaluation,
- patients who develop major complications after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire
Postoperative recovery is a complex process influenced by various factors such as patients, surgical methods and anesthetic properties. Such factors can be accompanied by many negative situations. Previous studies evaluating recovery following anesthesia primarily evaluated the incidence of morbidity, mortality, adverse anesthesia-related outcomes, and changes in vital signs (1-4). These parameters are important, but the quality of recovery of patients has been neglected in most studies. Therefore, various patient-reported outcome measurement scales and tools have been developed (1,3-8). One of these scales is Stark et al. It is the QoR-15 questionnaire developed by in 2013 (4). QoR-15 aims to assess the quality of early recovery and emotional health of patients after surgery (4,6). It is a 15-item questionnaire assessing the patient's emotional state, physical comfort, psychological support, physical independence and pain. This one-page QoR-15 questionnaire has been shown to be highly valid and reliable in patients who have undergone general surgery (4).
QoR-15 has been verified and translated into many languages such as Japanese, French, Portuguese, Chinese, Swedish (13-17). It was reported in a systemic review that all translated versions of the QoR-15 had sufficient validity and reliability to assess the quality of postoperative recovery (19). However, an official Turkish version of the QoR-15 has not yet been developed or approved.
The aim of this study was to develop the Turkish version of the QoR-15 (QoR-15T) and to evaluate its validity, reliability and responsiveness for Turkish-speaking patients receiving general and regional anaesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the feasibility, reliability, validity, and responsiveness of the QoR-15T after surgery.
The QoR-15, a measurement tool to evaluate postoperative recovery in patients, consists of 15 items including pain, nausea, vomiting, and self-care status [9]. For each item, the patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery. QoR-15 has been verified and translated into many languages such as Japanese, French, Portuguese, Chinese, Swedish.
All translated versions of the QoR-15 were reported in a systemic review to have sufficient validity and reliability to assess the quality of postoperative recovery.The aim of this study is to develop the Turkish version of the QoR-15 (QoR-15T) and evaluate its validity, reliability and responsiveness for Turkish speaking patients receiving general and regional anesthesia.
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start4 Dec 2021
- Primary completion21 Jul 2022 (estimated)
- Study completion30 Jul 2022 (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 to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15TStudies of the same condition, open and under way.
- More trials run by Selcuk 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 crossover
- Time perspective
- Prospective
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE ASLANLAR, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124054
- Sponsor's protocol ID
- QoR-15
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aslanlar E, Aslanlar DA, Doganay C, Onal O, Sargin M, Cicekci F, Kara F, Kara I. The validity and reliability of the Turkish version of the quality of recovery-15 (QoR-15) questionnaire. Medicine (Baltimore). 2024 Apr 19;103(16):e37867. doi: 10.1097/MD.0000000000037867.
PubMed 38640327
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire
- ClinicalTrials.gov ID
- NCT05124054
- Acronym / sponsor ID
- QoR-15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 21 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 17 Nov 2021 (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 is a complex process influenced by various factors such as patients, surgical methods and anesthetic properties. Such factors can be accompanied by many negative situations. Previous studies evaluating recovery following anesthesia primarily evaluated the incidence of morbidity, mortality, adverse anesthesia-related outcomes, and changes in vital signs (1-4). These parameters are important, but the quality of recovery of patients has been neglected in most studies. Therefore, various patient-reported outcome measurement scales and tools have been developed (1,3-8). One of these scales is Stark et al. It is the QoR-15 questionnaire developed by in 2013 (4). QoR-15 aims to assess the quality of early recovery and emotional health of patients after surgery (4,6). It is a 15-item questionnaire assessing the patient's emotional state, physical comfort, psychological support, physical independence and pain. This one-page QoR-15 questionnaire has been shown to be highly valid and reliable in patients who have undergone general surgery (4).
QoR-15 has been verified and translated into many languages such as Japanese, French, Portuguese, Chinese, Swedish (13-17). It was reported in a systemic review that all translated versions of the QoR-15 had sufficient validity and reliability to assess the quality of postoperative recovery (19). However, an official Turkish version of the QoR-15 has not yet been developed or approved.
The aim of this study was to develop the Turkish version of the QoR-15 (QoR-15T) and to evaluate its validity, reliability and responsiveness for Turkish-speaking patients receiving general and regional anaesthesia.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18 and 65 who will undergo elective surgery and who is native Turkish speaker
Key inclusion criteria (2 listed)
- native turkish speaker
- scheduled elective surgery
Key exclusion criteria (7 listed)
- with cognitive impairment,
- American Society of Anesthesiologists (ASA) physical condition IV or higher,
- patients with psychiatric disorders,
- history of alcohol or any other substance abuse
- patients expected to need postoperative mechanical ventilation (eg, cardiovascular surgery requiring cardiopulmonary bypass, microvascular reconstruction surgery for oral and maxillofacial cancer, etc.)
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
to evaluate the feasibility, reliability, validity, and responsiveness of the QoR-15T after surgery.
Time frame: 5 min
The QoR-15, a measurement tool to evaluate postoperative recovery in patients, consists of 15 items including pain, nausea, vomiting, and self-care status [9]. For each item, the patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery. QoR-15 has been verified and translated into many languages such as Japanese, French, Portuguese, Chinese, Swedish. All translated versions of the QoR-15 were reported in a systemic review to have sufficient validity and reliability to assess the quality of postoperative recovery.The aim of this study is to develop the Turkish version of the QoR-15 (QoR-15T) and evaluate its validity, reliability and responsiveness for Turkish speaking patients receiving general and regional anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 38640327Aslanlar E, Aslanlar DA, Doganay C, Onal O, Sargin M, Cicekci F, Kara F, Kara I. The validity and reliability of the Turkish version of the quality of recovery-15 (QoR-15) questionnaire. Medicine (Baltimore). 2024 Apr 19;103(16):e37867. doi: 10.1097/MD.0000000000037867.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15T, run by Selcuk University at 1 site 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 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: status not confirmed, as of the sponsor's last update on 25 Jul 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the feasibility, reliability, validity, and responsiveness of the QoR-15T after surgery. (time frame: 5 min). 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 NCT05124054, 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 25 Jul 2022.