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

June 6, 2020 updated by: Ayşe Adıgüzel Bayar, Muğla Sıtkı Koçman University

Adaptation of The Functional Difficulties Questionnaire-shortened Version Survey to Turkish and Determination of Psychometric Properties: Validity and Reliability Study.

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aydın, Turkey
        • Private Medinova Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Having undergone coronary artery bypass surgery with median sternotomi

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Functional Status (with FDQ-s: Turkish version questionnaire)
Time Frame: 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.
First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)
Time Frame: 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.
Day of discharge (post-op), 15th day after surgery (control day).
Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)
Time Frame: 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.
Day of discharge (post-op), 15th day after surgery (control day).
Change of the Pain Status: (Visual Analogue Scale)
Time Frame: 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.
First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).
Change of the Mobility Status: (Perme Intensive Care Mobility Score)
Time Frame: 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.
Day of discharge (post-op), 15th day after surgery (control day).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: First day at the hospital (pre-op)
Age (Year)
First day at the hospital (pre-op)
Height
Time Frame: First day at the hospital (pre-op)
Height in meters
First day at the hospital (pre-op)
BMI
Time Frame: First day at the hospital
BMI (weight and height combined to report BMI in kg/m²)
First day at the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

May 15, 2020

Study Completion (Anticipated)

June 18, 2020

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 6, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 6, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MSc Thesis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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