- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06434688
Body Awareness and Mental Fatigue in Neck Pain
Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Sıhhiye
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Ankara, Sıhhiye, Turkey, 06100
- Hacettepe University
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Contact:
- Selenay Aydoğdu, 1
- Phone Number: +90 5312723599
- Email: selenay.aydgd@gmail.com
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Contact:
- Nezire Köse, 2
- Phone Number: 0312 3052525
- Email: nkose@hacettepe.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Individuals experiencing neck pain
Study Group Inclusion Criteria:
Study Group Exclusion Criteria:
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The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.
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.
Neck disability index will be used to assess this parameter.
SF-12 will be used to assess quality of life.
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.
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.
Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.
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Healthy individuals without neck pain
Control Group Inclusion Criteria:
Control Group Exclusion Criteria:
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The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.
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.
SF-12 will be used to assess quality of life.
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.
Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mental Fatigue
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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General Body Awareness
Time Frame: 2024 may- 2024 July
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General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).
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2024 may- 2024 July
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Neck Disability
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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General health questionnaire
Time Frame: 2024 may - 2024 July
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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.
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2024 may - 2024 July
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weight transfer awareness
Time Frame: 2024 may- 2024 July
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Two scales were used to assess weight transfer awareness.
Results will be recorded in kg.
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2024 may- 2024 July
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neck awareness
Time Frame: 2024 may- 2024 July
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Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
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2024 may- 2024 July
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mindfulness
Time Frame: 2024 may- 2024 July
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Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness
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2024 may- 2024 July
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interoception
Time Frame: 2024 may- 2024 July
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For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
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2024 may- 2024 July
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proprioception
Time Frame: 2024 may- 2024 July
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The Cervical Range of Motion (CROM) device is used to assess proprioception.
The device assesses proprioception in 6 different directions of the neck.
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2024 may- 2024 July
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verticality
Time Frame: 2024 may- 2024 July
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The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
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2024 may- 2024 July
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extroception
Time Frame: 2024 may- 2024 July
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The sense of extroception will be evaluated with the right-left hand confusion test.
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2024 may- 2024 July
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Assessment
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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Pain self efficacy
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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Anxiety and Depression
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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Range of motion
Time Frame: 2024 may- 2024 July
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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
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2024 may- 2024 July
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Posture Assesment
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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Weight transfer
Time Frame: 2024 may- 2024 July
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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.
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2024 may- 2024 July
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
- The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception
- Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 10557444
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
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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