## Protocol Section
### Identification Module
**NCT ID:** NCT06434688

**Brief Title:** Body Awareness and Mental Fatigue in Neck Pain

**Official Title:** Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain

#### Organization Study ID Info
**ID:** 10557444
#### Organization
**Class:** OTHER
**Full Name:** Hacettepe University
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-27

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hacettepe University

#### Responsible Party

**Investigator Affiliation:** Hacettepe University

**Investigator Full Name:** Selenay Aydogdu

**Investigator Title:** principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between awareness levels and neck disability level and quality of life.

The secondary aim was to examine the relationships between pain intensity, frequency, duration, pain self-efficacy, physical condition, anxiety and depression, mental fatigue and awareness levels in people with chronic neck pain.

**Detailed Description:** Neck pain is a prevalent musculoskeletal issue that can cause significant disability. Individuals with neck pain may experience changes in muscle structure and behavior, as well as sensory-perceptual-motor issues such as decreased proprioception and related neuromuscular changes. Additionally, neck pain can lead to psychological problems such as anxiety and depression.Although some awareness parameters have been evaluated in studies on neck pain in the literature and it has been shown that chronic pain is associated with impaired body awareness and that this impairment contributes to and/or maintains chronic pain, no study has been found to examine all awareness parameters in detail. Another cause that compromises the accuracy of information contributing to body awareness is mental fatigue. Mental fatigue can negatively affect a person's level of perception. In one study, it was stated that mental fatigue was a determinant of neck disability, but studies on this subject were found to be very insufficient. Therefore, the aim of this study was to examine the sub-parameters of awareness and mental fatigue in people with chronic neck pain, to compare them with healthy people and to examine the relationship between the parameters evaluated.

### Conditions Module

**Conditions:**

- Neck Pain

- Mental Fatigue

- Mindfulness

- Awareness

**Keywords:**

- mental fatigue

- Mindfulness

- Interoception

- Proprioception

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 66

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Study Group Inclusion Criteria:

* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental Status Examination.
* Being able to read and write.
* Being willing to participate in the study.

Study Group Exclusion Criteria:

* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurologic diseases.
* Inflammatory diseases
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric disorders such as bipolar disorder and panic attacks.
* Vision problems that do not improve despite vision aids.
* Pregnancy

**Intervention Names:**

- Other: Mental Fatigue:

- Other: Body Awareness:

- Other: Neck Disability Level

- Other: Quality Of Life

- Other: Pain Assessment:

- Other: Physical Condition:

- Other: Anxiety and Depression:

**Label:** Individuals experiencing neck pain

#### Arm Group 2

**Description:** Control Group Inclusion Criteria:

* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.

Control Group Exclusion Criteria:

* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group

**Intervention Names:**

- Other: Mental Fatigue:

- Other: Body Awareness:

- Other: Quality Of Life

- Other: Physical Condition:

- Other: Anxiety and Depression:

**Label:** Healthy individuals without neck pain

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy individuals without neck pain

- Individuals experiencing neck pain

**Description:** The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.

**Name:** Mental Fatigue:

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Healthy individuals without neck pain

- Individuals experiencing neck pain

**Description:** Individuals' general body awareness will be assessed with the Body Awareness Questionnaire (BAQ).

Neck awareness of individuals will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).

Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness.

- In-body awareness:

For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.

To evaluate proprioception, a Cervical Range of Motion (CROM) device is used.

The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.

Two scales will be used to assess people's awareness of weight transfer symmetry.

- Out of Body Awareness:

"Right-Left Confusion Hand Test" will be used to evaluate the mental rotation skill within the scope of the sense of extroception.

**Name:** Body Awareness:

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Individuals experiencing neck pain

**Description:** Neck disability index will be used to assess this parameter.

**Name:** Neck Disability Level

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Healthy individuals without neck pain

- Individuals experiencing neck pain

**Description:** SF-12 will be used to assess quality of life.

**Name:** Quality Of Life

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Individuals experiencing neck pain

**Description:** Pain intensity will be assessed by Visual Analog Scale (VAS). In addition, pain duration and pain frequency will be questioned. The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain.

**Name:** Pain Assessment:

**Type:** OTHER

#### Intervention 6

**Arm Group Labels:**

- Healthy individuals without neck pain

- Individuals experiencing neck pain

**Description:** Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device.

New York Posture Rating Scale will be used to evaluate posture.

Symmetry of weight transfer to both lower extremities of the individuals in standing upright position will be evaluated.

**Name:** Physical Condition:

**Type:** OTHER

#### Intervention 7

**Arm Group Labels:**

- Healthy individuals without neck pain

- Individuals experiencing neck pain

**Description:** Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.

**Name:** Anxiety and Depression:

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. It includes questions about general fatigue, lack of initiative, mental fatigue, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to be emotional, irritability, sensitivity to light and noise, decreased or increased sleep. It has a 7-point Likert-type scale and is scored from 0 to 3. A rating of 0 indicates normal functioning, 1 indicates mild problem, 2 indicates significant problem and 3 indicates maximum problem. According to the total score, 0-10= no mental fatigue problem, 10.5-14.5= mild mental fatigue, 15-20= quite serious mental fatigue, ≥ 20.5= serious mental fatigue.

**Measure:** Mental Fatigue

**Time Frame:** 2024 may- 2024 July

**Description:** General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).

**Measure:** General Body Awareness

**Time Frame:** 2024 may- 2024 July

**Description:** Neck disability index will be used to assess this parameter. The questionnaire contains 10 questions related to different activities. Each question is scored between 0 and 5. The level of disability is determined according to the total score obtained from the questionnaire. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25- 34 = severe disability, 35 and above = total disability.

**Measure:** Neck Disability

**Time Frame:** 2024 may- 2024 July

**Description:** The SF-12, which is more practical and shorter than the SF-36 but contains the same sub-dimensions as the SF-36, will be used to assess quality of life. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role, body pain, general health, energy, social functioning, emotional role and mental health. The questionnaire scoring is calculated under the headings of physical and mental health, which are the two main components of general health.

**Measure:** General health questionnaire

**Time Frame:** 2024 may - 2024 July

**Description:** Two scales were used to assess weight transfer awareness. Results will be recorded in kg.

**Measure:** weight transfer awareness

**Time Frame:** 2024 may- 2024 July

**Description:** Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).

**Measure:** neck awareness

**Time Frame:** 2024 may- 2024 July

**Description:** Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness

**Measure:** mindfulness

**Time Frame:** 2024 may- 2024 July

**Description:** For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.

**Measure:** interoception

**Time Frame:** 2024 may- 2024 July

**Description:** The Cervical Range of Motion (CROM) device is used to assess proprioception. The device assesses proprioception in 6 different directions of the neck.

**Measure:** proprioception

**Time Frame:** 2024 may- 2024 July

**Description:** The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.

**Measure:** verticality

**Time Frame:** 2024 may- 2024 July

**Description:** The sense of extroception will be evaluated with the right-left hand confusion test.

**Measure:** extroception

**Time Frame:** 2024 may- 2024 July

#### Secondary Outcomes

**Description:** Pain intensity will be assessed by Visual Analog Scale (VAS).0: I have no pain 10: I have unbearable pain In addition, pain duration and pain frequency will be questioned.

**Measure:** Pain Assessment

**Time Frame:** 2024 may- 2024 July

**Description:** The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain. Each item is rated on a 7-point Likert-type scale (0=not at all confident, 6=fully confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.

**Measure:** Pain self efficacy

**Time Frame:** 2024 may- 2024 July

**Description:** Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety. Both questionnaires have 21 questions and are scored between 0-3. According to the total scores, 0-9 points in the Beck Depression Scale indicates normal level, 10-16 points indicates mild depression, 17-29 points indicates moderate depression and 30-63 points indicates severe depression. On the Beck Anxiety Scale, 0-17 points are classified as low anxiety, 18-24 points as moderate anxiety, and 25 and above points as high anxiety.

**Measure:** Anxiety and Depression

**Time Frame:** 2024 may- 2024 July

**Description:** Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. Active ranges of motion in flexion-extension, lateral flexion and rotation directions will be recorded with the subjec

**Measure:** Range of motion

**Time Frame:** 2024 may- 2024 July

**Description:** New York Posture Rating Scale will be used to evaluate posture. Posture changes that may occur in 13 different parts of the body including head, neck, shoulders, shoulders, back, waist, hip and ankle are observed. According to the results of the observation, five (5) points are given if the person has proper posture, three (3) points if the posture is moderately impaired, and one (1) point if there is a serious impairment. A high score means that the posture is good.

**Measure:** Posture Assesment

**Time Frame:** 2024 may- 2024 July

**Description:** Symmetry of weight transfer to both lower extremities of the individuals in a standing upright position will be evaluated. It will be recorded in kg.

**Measure:** Weight transfer

**Time Frame:** 2024 may- 2024 July

### Eligibility Module

**Eligibility Criteria:** Study Group Inclusion Criteria:

* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Being volunteer to participate in the study.

Study Group Exclusion Criteria:

* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurological diseases.
* Inflammatory diseases (rheumatoid arthritis, etc.).
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities.
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric illnesses such as bipolar disorder, psychotic illnesses and panic attacks.
* Vision problems that do not fully recover despite vision aids (glasses, etc.).
* Pregnancy status

Control Group Inclusion Criteria:

* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.

Control Group Exclusion Criteria:

* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** individuals with neck pain and healthy individuals without neck pain

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Contacts:**

***Contact 1:***

- **Email:** selenay.aydgd@gmail.com

- **Name:** Selenay Aydoğdu, 1

- **Phone:** 5312723599

- **Phone Ext:** +90

- **Role:** CONTACT

***Contact 2:***

- **Email:** nkose@hacettepe.edu.tr

- **Name:** Nezire Köse, 2

- **Phone:** 3052525

- **Phone Ext:** 0312

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Hacettepe University

**State:** Sıhhiye

**Zip:** 06100

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Amiri Arimi S, Ghamkhar L, Kahlaee AH. The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception. Pain Med. 2018 Oct 1;19(10):2077-2088. doi: 10.1093/pm/pnx331.

**PMID:** 29304254

**Citation:** Dere T, Alemdaroglu-Gurbuz I. Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain. Somatosens Mot Res. 2023 Mar 10:1-8. doi: 10.1080/08990220.2023.2186390. Online ahead of print.

**PMID:** 36897182

#### See Also Links

**Label:** The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception

**URL:** https://pubmed.ncbi.nlm.nih.gov/29304254/

**Label:** Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain

**URL:** https://pubmed.ncbi.nlm.nih.gov/36897182/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M21485

- Name: Neck Pain

- Relevance: HIGH

- As Found: Neck Pain

- ID: M8364

- Name: Fatigue

- Relevance: HIGH

- As Found: Fatigue

- ID: M8365

- Name: Mental Fatigue

- Relevance: HIGH

- As Found: Mental Fatigue

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005221

- Term: Fatigue

- ID: D000019547

- Term: Neck Pain

- ID: D000005222

- Term: Mental Fatigue

### Misc Info Module

- Version Holder: 2024-05-31
