Clinical trial NCT05124054: The Validity and Reliability of the Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire
Official title: Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15T
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 and 65 who will undergo elective surgery and who is native Turkish speaker

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* native turkish speaker
* scheduled elective surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: to evaluate the feasibility, reliability, validity, and responsiveness of the QoR-15T after surgery.
timeFrame: 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References: