Clinical trial NCT04425525: The Functional Difficulties Questionnaire-shortened Version: Turkish Translation, Validity and Reliability Study.
Official title: Adaptation of The Functional Difficulties Questionnaire-shortened Version Survey to Turkish and Determination of Psychometric Properties: Validity and Reliability Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Status After CABG Surgery
Outcome Measure
Keywords: heart surgery, function, measure, validity, reliability.
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Aydın Private Medinova Hospital
First posted: 2020-06-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Having undergone coronary artery bypass surgery with median sternotomi

Brief summary: The Functional Difficulties Questionnaire-shortened version "(FDQ-s) is a unique questionnaire that aimed at evaluating the functional performance of the upper extremities and trunk following cardiothoracic surgery.

Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its psychometric properties, validity and reliability.

Detailed description: Cardiac surgeries performed by sternotomy method are the most common surgical treatment method in coronary artery disease. Although the median sternotomy has advantages in terms of ease of application, cost and long-term survival, muskuloskeletal complications can be encountered in the postoperative period.

In the studies conducted, it was found that patients had difficulties in functional activities including mobilization and daily life activities after median sternotomy. Also restrictions or loss of motion can be observed in the joint range of motion of the shoulder joint and thoracic region.

The FDQ-s scale consists of 10 functional tasks developed by Sturgess et al. These tasks are activities such as coughing, sneezing, deep breathing, movements involving the upper extremity, turning in bed, sitting upright in the chair, and ambulation. When applying FDQ-s, patients will mark how hard they are in each task on the 100 mm straight line. The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score will be determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's difficulty level is high.

Although there are many functional difficulties faced by patients in the postoperative period, there is no outcome measurement in our language that evaluates the level of these difficulties globally and objectively.

Our research will be done due to the elimination of this deficiency in the literature.

Eligibility criteria: Inclusion Criteria:

* Being over the age of 18
* Having undergone coronary artery bypass surgery (via median sternotomi)

Exclusion Criteria:

* Not having ability to read and write in Turkish
* Having cognitive impairment
* Being in the intensive care unit for more than five days due to medical reasons.
* Having undergone surgery involving thorax or upper extremity in the last 6 months.
* Having neurologic or musculoskeletal problems to prevent evaluation, ambulation and exercise.
* Patients who have an infection or unhealed scar after surgery even if their first measurements are made

Primary outcomes:
measure: Change of the Functional Status (with FDQ-s: Turkish version questionnaire)
timeFrame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control).
Secondary outcomes:
measure: Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)
timeFrame: Day of discharge (post-op), 15th day after surgery (control day).
measure: Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)
timeFrame: Day of discharge (post-op), 15th day after surgery (control day).
measure: Change of the Pain Status: (Visual Analogue Scale)
timeFrame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).
measure: Change of the Mobility Status: (Perme Intensive Care Mobility Score)
timeFrame: Day of discharge (post-op), 15th day after surgery (control day).
Other outcomes:
measure: Age
timeFrame: First day at the hospital (pre-op)
measure: Height
timeFrame: First day at the hospital (pre-op)
measure: BMI
timeFrame: First day at the hospital
Locations:
city: Aydın
country: Turkey
facility: Private Medinova Hospital
Study officials:
affiliation: Muğla Sıtkı Koçman University/ Private Medinova Hospital
name: Ayşe Adıgüzel Bayar, MSc Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Baki Umut Tuğay, Prof. Dr.
role: STUDY_DIRECTOR
References: