The Functional Difficulties Questionnaire-shortened Version: Turkish Translation, Validity and Reliability Study.

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04425525
Collaborator
Aydın Private Medinova Hospital (Other)
70
1
19.5
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    70 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Adaptation of The Functional Difficulties Questionnaire-shortened Version Survey to Turkish and Determination of Psychometric Properties: Validity and Reliability Study.
    Actual Study Start Date :
    Nov 1, 2018
    Actual Primary Completion Date :
    May 15, 2020
    Anticipated Study Completion Date :
    Jun 18, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Change of the Functional Status (with FDQ-s: Turkish version questionnaire) [First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control).]

      FDQ-S is a questionnaire created to evaluate the difficulties faced by patients undergoing cardiac surgery, especially when performing functional tasks of the thoracic region and upper extremity. The questionnaire consisting of 10 questions in total, the patients marked how much difficulty they had in each task, on a 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 was 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 strain level is high. With time frames we aimed to evaluate the change of the difficulty of patients function.

    Secondary Outcome Measures

    1. Change of the Mobility Status : (Barthel İndex of Activities of Daily Living) [Day of discharge (post-op), 15th day after surgery (control day).]

      Barthel Index determines the level of addiction of the patient in 10 sections: nutrition, washing, self-care, dressing and bowel care, bladder care, toilet care, wheelchair to bed and vice versa, mobility (walking on a smooth surface, using the wheelchair: if appropriate), going up and down stairs.The total score is in the range of 0-100, which means 0-20 points: fully dependent, 21-61: highly dependent, 62-90: moderately dependent, 91-99: slightly dependent, 100 points: fully independent.With time frames we aimed to evaluate the change of the mobility scores.

    2. Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire) [Day of discharge (post-op), 15th day after surgery (control day).]

      SF-36 is the most common scale used to measure individuals' quality of life. This scale examines 8 dimensions of health with 36 items such as physical function, role restrictions (due to physical and emotional problems), social function, mental health, vitality (energy), pain and general perception of health.Instead of giving only one total score, the scale gives total score separately for each subscale.100 points indicate good health, 0 points indicate bad health. With time frame we aimed to evaluate the cange of the life quality score of patients.

    3. Change of the Pain Status: (Visual Analogue Scale) [First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).]

      The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance from the 0 point to the place marked by the patient indicates the pain of the patient. With time frame we aimed to evaluate the change of the life quality score of patients.

    4. Change of the Mobility Status: (Perme Intensive Care Mobility Score) [Day of discharge (post-op), 15th day after surgery (control day).]

      The Perme ICU Mobility Score is a tool developed to measure the patient's mobility status starting with the ability to follow commands and culminating in the distance walked in two minutes. A total score of 3 or 4 is given for each item, reflecting the patient's mobility. A high score indicates a small amount of mobility barrier and low help, while a low score indicates more mobility and more help needed for mobility. With time frame we aimed to evaluate the change of the mobility score.

    Other Outcome Measures

    1. Age [First day at the hospital (pre-op)]

      Age (Year)

    2. Height [First day at the hospital (pre-op)]

      Height in meters

    3. BMI [First day at the hospital]

      BMI (weight and height combined to report BMI in kg/m²)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Private Medinova Hospital Aydın Turkey

    Sponsors and Collaborators

    • Muğla Sıtkı Koçman University
    • Aydın Private Medinova Hospital

    Investigators

    • Principal Investigator: Ayşe Adıgüzel Bayar, MSc Student, Muğla Sıtkı Koçman University/ Private Medinova Hospital
    • Study Director: Baki Umut Tuğay, Prof. Dr., Muğla Sıtkı Koçman University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayşe Adıgüzel Bayar, Physiotherapist, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT04425525
    Other Study ID Numbers:
    • MSc Thesis
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayşe Adıgüzel Bayar, Physiotherapist, Muğla Sıtkı Koçman University

    Study Results

    No Results Posted as of Jun 11, 2020