Determines of Quality of Life in Patients

April 29, 2020 updated by: Ayça Aytar TIĞLI, Baskent University

Nonspecific Neck Patients's Quality of Life and Their Predictors

Pain, muscle spasm, loss of muscle strength and impaired posture adversely affect the daily life activities and quality of life of neck pain patients.However, the quality of life; It is a multifaceted concept that includes not only the age, sex, marital status, educational status and duration of pain, but also the number of children, BMI, depression, sleep quality, pain-related inadequacy and fatigue. Therefore, considering all these; quality of life; The aim of our study was to determine the factors affecting the quality of life in nonspesific neck patients with the effect that the determinants affecting physical, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty and mental health may be different.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include 93 people with a diagnosis neck disease who apply to the physical therapy outpatient clinic. After recorded sociodemographic and clinical characteristics of the individuals, some evaluations will be done only once. The evaluations to be used in the study are as follows: Pain Assesment will be evaluated with McGill Pain Questionnaire, Sleep disorders will be evaluated with Pitsburgh Sleep Quality Index (PSQI), Fatigue level will be assessed by the Fatigue Questionnaire, Beck Depression Inventory (BDI) will be used to determine depression levels. The quality of life of the subjects wiil be evaluate by using the Short Form-36 questionnaire.

Study Type

Observational

Enrollment (Actual)

93

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

      • Ankara, Turkey
        • Ayça Aytar

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

people with a diagnosis of neck disease living in Ankara and who can answer the study questions

Description

Inclusion Criteria:

1) People 18 years and older

Exclusion Criteria:

  1. Hospitalized people
  2. Newly Operated People
  3. People with psychological diagnosis

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
neck pain patients
servical disk hernisi servical spondilosis servical problems
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
control
healthy people
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

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
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.
27 february 2020
IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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])
27 february 2020
IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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
27 february 2020
IS FATIGUE DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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.
27 february 2020
IS DEPRESSION DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
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
27 february 2020
IS Anxıety DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
te report the effect of anxıety State-Trait Anxiety Inventory (STAI) will be used.The higher the score, the higher the level of anxiety.
27 february 2020
Is pain disability DETERMINING THE QUALITY OF LIFE
Time Frame: 27 february 2020
to report disability levels we will be used The Pain Disability Index.High score indicates high disability
27 february 2020

Collaborators and Investigators

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

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)

September 30, 2019

Primary Completion (Actual)

March 25, 2020

Study Completion (Actual)

April 25, 2020

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

December 14, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA19/406

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

product manufactured in and exported from the U.S.

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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