- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201379
Determines of Quality of Life in Patients
Nonspecific Neck Patients's Quality of Life and Their Predictors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Ayça Aytar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1) People 18 years and older
Exclusion Criteria:
- Hospitalized people
- Newly Operated People
- People with psychological diagnosis
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
neck pain patients
servical disk hernisi servical spondilosis servical problems
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The sociodemographic and clinical characteristics of the individuals who meet the study criteria will be recorded.
Evaluations of the participants will be done only once
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control
healthy people
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The sociodemographic and clinical characteristics of the individuals who meet the study criteria will be recorded.
Evaluations of the participants will be done only once
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE
Time Frame: 27 february 2020
|
to reported determining factors affecting their quality of life Short form-SF36 .All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table (STEP I chart). The scores from those questions that address each specific area of functional health status (STEP II chart) are then averaged together, for a final score within each of the 8 dimensions measured. (eg pain, physical functioning etc.) |
27 february 2020
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IS PAIN DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
|
MCMcGill Pain Questionnaire will be used to report pain.The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience.
The first part consists of an anatomic drawing of the human form on which the patient marks where his or her pain is located.
The second part of the MPQ is a VDS that allows the patient to record the intensity level of his or her current pain experience.
The third part of the MPQ is a pain verbal descriptor inventory consisting of 72 descriptive adjectives.
The patient is asked to review this list of pain descriptors and circle the ones that serve to best describe his or her current pain experience.
Each part or dimension of the MPQ is individually scored and a cumulative total score is also recorded.
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27 february 2020
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IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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Visual Analog Score for pain, Physicians Global Assessment to measure quality of life.The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme .r
pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
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27 february 2020
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IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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te report the effect of sleep quality Pitsburgh Sleep Quality Index will be used.
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult.
It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.
The client self rates each of these seven areas of sleep.
Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale.
A global sum of "5"or greater indicates a "poor" sleeper
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27 february 2020
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IS FATIGUE DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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Fatigue Questionnaire will be used to report fatigue.Scoring using a bimodal response system or a Likert score with weights assigned to each response choice.
Likert or bimodal rating scales with 4 response options.
For the Likert Scale: better than usual = 0, no more than usual = 1, worse than usual = 2, much worse than usual = 3.
For the bimodal scale: better than usual = 0, no more than usual = 0, worse than usual = 1, much worse than usual = 1.
Sum all items for a total score.
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27 february 2020
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IS DEPRESSION DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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to report depression levels Beck Depression Inventory (BDI) will be used.Each of the four multiple choice answers is assigned a point value from 0 to 3. At the end of the assessment, you add up the total points from the answers throughout the 21 questions.
Hıgh scores ındıcate worse depressıon levels
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27 february 2020
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IS Anxıety DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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te report the effect of anxıety State-Trait Anxiety Inventory (STAI) will be used.The higher the score, the higher the level of anxiety.
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27 february 2020
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Is pain disability DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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to report disability levels we will be used The Pain Disability Index.High score indicates high disability
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27 february 2020
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA19/406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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