## Protocol Section
### Identification Module
**NCT ID:** NCT04201379

**Brief Title:** Determines of Quality of Life in Patients

**Official Title:** Nonspecific Neck Patients's Quality of Life and Their Predictors

#### Organization Study ID Info
**ID:** KA19/406
#### Organization
**Class:** OTHER
**Full Name:** Baskent University
### Status Module
#### Completion Date
**Date:** 2020-04-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-04-30

**Type:** ACTUAL

**Last Update Submit Date:** 2020-04-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-03-25

**Type:** ACTUAL

#### Start Date
**Date:** 2019-09-30

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2019-12-17
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-28
**Study First Submit QC Date:** 2019-12-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Baskent University

#### Responsible Party

**Investigator Affiliation:** Baskent University

**Investigator Full Name:** Ayça Aytar TIĞLI

**Investigator Title:** Physical therapist Phd

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Chronic Neck Pain

**Keywords:**

- chronic

- neckpain

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 93

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** servical disk hernisi servical spondilosis servical problems

**Intervention Names:**

- Other: quality of life assesment

**Label:** neck pain patients

#### Arm Group 2

**Description:** healthy people

**Intervention Names:**

- Other: quality of life assesment

**Label:** control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- control

- neck pain patients

**Description:** 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

**Name:** quality of life assesment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.)

**Measure:** DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** 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.

**Measure:** IS PAIN DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** 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 \[100-mm scale\])

**Measure:** IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** 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

**Measure:** IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** 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.

**Measure:** IS FATIGUE DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** 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

**Measure:** IS DEPRESSION DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** te report the effect of anxıety State-Trait Anxiety Inventory (STAI) will be used.The higher the score, the higher the level of anxiety.

**Measure:** IS Anxıety DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

**Description:** to report disability levels we will be used The Pain Disability Index.High score indicates high disability

**Measure:** Is pain disability DETERMINING THE QUALITY OF LIFE

**Time Frame:** 27 february 2020

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1) People 18 years and older

Exclusion Criteria:

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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ayça Aytar

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M21485

- Name: Neck Pain

- Relevance: HIGH

- As Found: Neck Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019547

- Term: Neck Pain

### Misc Info Module

- Version Holder: 2024-05-24
