xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05994066</url>
    </required_header>
    <id_info>
      <org_study_id>Sleep disturbance,physical and</org_study_id>
      <nct_id>NCT05994066</nct_id>
    </id_info>
    <brief_title>Sleep Disturbance,Physical and Mental Fatigue on Mechanical Neck Pain</brief_title>
    <official_title>Effect of Sleep Quality,Physical and Mental Fatigue on Mechanical Neck Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mechanical neck pain is a prevalent problem in community and it can lead to disability.&#xD;
  &#xD;
        In current community, increasing of life stress on individual may lead to sleep disorders,&#xD;
        mental and physical fatigue.&#xD;
  &#xD;
        Objectives of study is to investigate the effect of sleep quality, mental and physical&#xD;
        fatigue on mechanical neck pain.&#xD;
  &#xD;
        Methods and Materials Two hundred thirty individuals were having mechanical neck pain . Neck&#xD;
        disability index, chalder fatigue scale and Pittsburg sleep quality index were applied on all&#xD;
        individuals participating in the study , NDI was used to determine the pain and functional&#xD;
        disability of the participants , PSQI was used to assess the sleep quality, lastly the CFS&#xD;
        was used to determine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Our study considered as an observational cross - sectional study.&#xD;
  &#xD;
        Sample size :&#xD;
  &#xD;
        Individual's ;230 patient with mechanical neck pain will participate in the study The&#xD;
        inclusion criteria were age between 18 -60 years , who do have neck disability index score&#xD;
        more than (4) points, they have being included in our study. The exclusion criteria were&#xD;
        people who are having any cervical injury( fracture,whiplash injury) cervical disc ,&#xD;
        neurological disease, past surgery in neck region. Also we excluded who has been scored with&#xD;
        4 points or less in NDI . The study will be in the out clinic of orthopedic in faculty of&#xD;
        physical therapy , cairo university&#xD;
  &#xD;
        Material tool :&#xD;
  &#xD;
        We used three index , NECK DISABILITY INDEX [NDI] , CHALDER FATIGUE SCALE [CFS] , PITTSBURGH&#xD;
        SLEEP QUALITY SCALE [PSQI]. -NDI : neck disability index is consists of 10 questions&#xD;
        including = pain severity,ability of personal care ,lifting weight, job capability, headaches&#xD;
        intense , concentration, quality of sleeping and driving and recreation activities. The total&#xD;
        score ranges between 0- 50 points . Zero to 4 points mean( NO DISABILITY), 5 to 14 points&#xD;
        means (LIGHT DISABILITY ) , 15 to 24 points means ( MODERATE DISABILITY ), 25 to 34 points&#xD;
        means (SEVERE DISABILITY) 35 to 50 points means (COMPLETE DISABILITY).&#xD;
  &#xD;
        - CFS : The CFS is consisting of 11 questions including a seven item physical fatigue&#xD;
        subdimension and a four item mental fatigue sub-dimension.The physical fatigue subdimension&#xD;
        score ranges from 0 to 21, the mental fatigue sub-dimension score from 0 to12 The total&#xD;
        fatigue score is from 0-33. High scores indicates a greater fatigue level.&#xD;
  &#xD;
        - PSQI : The scale is consisting of 24 items,19 items are filled by the individuals,while 5&#xD;
        are filled by the bedmate*if they have one*. 18 of 19 items that filled by the individual&#xD;
        himself&#xD;
  &#xD;
        \herself are scored and used to asses sleep quality,while the remaining 6 items are used to&#xD;
        have clinical inflammation. It has 7 components:&#xD;
  &#xD;
          1. subjective sleep quality&#xD;
  &#xD;
          2. sleep latency&#xD;
  &#xD;
          3. sleep duration&#xD;
  &#xD;
          4. habitual sleep efficiency&#xD;
  &#xD;
          5. sleep disturbances&#xD;
  &#xD;
          6. use of sleeping pills&#xD;
  &#xD;
          7. day time dysfunction . The total PUKIN score is obtained by summing the score of the&#xD;
             components. The total of each item is 0-3 while the total score of PUKI is ranging&#xD;
             between 0-21 . High score indicates poor sleep quality. A total score of 5 or less is&#xD;
             indicating good sleep quality, while scores above 5 indicates poor sleep quality.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Arabic version of NDIto determine the pain experience and functional disability of the participants.</measure>
      <time_frame>1 month</time_frame>
      <description>NDI consists of 10 questions concern of the pain severity, ability for personal care, lifting weight, job capability headache intensity, concentration, quality of sleeping and driving and recreation activities. Total score ranges between 0 to 50 points. Zero to four points mean &quot;no disability&quot;, 5 to 14 points mean &quot;light disability&quot;, 15 to 24 points mean &quot;moderate disability&quot;, 25 to 34 points mean &quot;severe disability&quot;, and 35 to 50 points mean &quot;complete disability&quot; (15).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>1 month</time_frame>
      <description>In this scale consisting of 24 items, 19 items are filled in by the individual, while five items are filled in by the person's bedmate. Eighteen of the 19 items that need to be answered by the individual are scored and used to assess sleep quality, while the remaining six items are used to have clinical information. It has seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. The total PUKI score is obtained by summing the scores of the components. The total score of each component varies between zero to three and the total score of PUKI ranges from 0 to 21. High scores indicate poor sleep quality. A total score of five or less indicates good sleep quality, while scores above 5 indicate poor sleep quality (16).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chalder Fatigue Scale (CFS)</measure>
      <time_frame>1 month</time_frame>
      <description>CFS consists of 11 questions including a 7-item physical fatigue sub-dimension and a 4-item mental fatigue sub-dimension (19). 4-point Likert scale was used. The scoring of each item varies between zero to three points. The physical fatigue sub-dimension score ranges from 0 to 21, the mental fatigue sub-dimension score ranges from 0 to 12, and the total fatigue score ranges from 0 to 33. High scores indicate a greater fatigue level (18). The arabic version of the questionnaire was used in the study (19).</description>
    </primary_outcome>
    <enrollment type="Anticipated">230</enrollment>
    <condition>Mechanical Neck Pain</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).</intervention_name>
      <description>Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Our study considered as an observational cross - sectional study. 230 patients will&#xD;
          participate in the stuudy The inclusion criteria will be age between 18 -60 years , who do&#xD;
          have neck disability index score more than (4) points, they have being included in our&#xD;
          study. The exclusion criteria were people who are having any cervical injury(&#xD;
          fracture,whiplash injury) cervical disc , neurological disease, past surgery in neck&#xD;
          region. Also we excluded who has been scored with 4 points or less in NDI . The study was&#xD;
          on online survey we used what'sup app and telegram app&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The inclusion criteria were age between 18 -60 years , who do have neck disability&#xD;
               index score more than (4) points, they have being included in our study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The exclusion criteria were people who are having any cervical injury(&#xD;
               fracture,whiplash injury) cervical disc , neurological disease, past surgery in neck&#xD;
               region. Also we excluded who has been scored with 4 points or less in NDI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>zeinab Ali, phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zeinab Ali, PHD</last_name>
      <phone>+201061360551</phone>
      <email>zeinaboh4@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Bonvanie IJ, Oldehinkel AJ, Rosmalen JGM, Janssens KAM. Sleep problems and pain: a longitudinal cohort study in emerging adults. Pain. 2016 Apr;157(4):957-963. doi: 10.1097/j.pain.0000000000000466.</citation>
      <PMID>26683236</PMID>
    </reference>
    <reference>
      <citation>Bjornsdottir SV, Jonsson SH, Valdimarsdottir UA. Mental health indicators and quality of life among individuals with musculoskeletal chronic pain: a nationwide study in Iceland. Scand J Rheumatol. 2014;43(5):419-23. doi: 10.3109/03009742.2014.881549. Epub 2014 May 12.</citation>
      <PMID>24814312</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Zeinab Abd el fattah Ali</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neck Pain</mesh_term>
      <mesh_term>Mental Fatigue</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05994066
  org study id: Sleep disturbance,physical and
  nct id: NCT05994066
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Mechanical neck pain is a prevalent problem in community and it can lead to disability.
  
        In current community, increasing of life stress on individual may lead to sleep disorders,
        mental and physical fatigue.
  
        Objectives of study is to investigate the effect of sleep quality, mental and physical
        fatigue on mechanical neck pain.
  
        Methods and Materials Two hundred thirty individuals were having mechanical neck pain . Neck
        disability index, chalder fatigue scale and Pittsburg sleep quality index were applied on all
        individuals participating in the study , NDI was used to determine the pain and functional
        disability of the participants , PSQI was used to assess the sleep quality, lastly the CFS
        was used to determine
  Our study considered as an observational cross - sectional study.
  
        Sample size :
  
        Individual's ;230 patient with mechanical neck pain will participate in the study The
        inclusion criteria were age between 18 -60 years , who do have neck disability index score
        more than (4) points, they have being included in our study. The exclusion criteria were
        people who are having any cervical injury( fracture,whiplash injury) cervical disc ,
        neurological disease, past surgery in neck region. Also we excluded who has been scored with
        4 points or less in NDI . The study will be in the out clinic of orthopedic in faculty of
        physical therapy , cairo university
  
        Material tool :
  
        We used three index , NECK DISABILITY INDEX [NDI] , CHALDER FATIGUE SCALE [CFS] , PITTSBURGH
        SLEEP QUALITY SCALE [PSQI]. -NDI : neck disability index is consists of 10 questions
        including = pain severity,ability of personal care ,lifting weight, job capability, headaches
        intense , concentration, quality of sleeping and driving and recreation activities. The total
        score ranges between 0- 50 points . Zero to 4 points mean( NO DISABILITY), 5 to 14 points
        means (LIGHT DISABILITY ) , 15 to 24 points means ( MODERATE DISABILITY ), 25 to 34 points
        means (SEVERE DISABILITY) 35 to 50 points means (COMPLETE DISABILITY).
  
        - CFS : The CFS is consisting of 11 questions including a seven item physical fatigue
        subdimension and a four item mental fatigue sub-dimension.The physical fatigue subdimension
        score ranges from 0 to 21, the mental fatigue sub-dimension score from 0 to12 The total
        fatigue score is from 0-33. High scores indicates a greater fatigue level.
  
        - PSQI : The scale is consisting of 24 items,19 items are filled by the individuals,while 5
        are filled by the bedmate*if they have one*. 18 of 19 items that filled by the individual
        himself
  
        \herself are scored and used to asses sleep quality,while the remaining 6 items are used to
        have clinical inflammation. It has 7 components:
  
          1. subjective sleep quality
  
          2. sleep latency
  
          3. sleep duration
  
          4. habitual sleep efficiency
  
          5. sleep disturbances
  
          6. use of sleeping pills
  
          7. day time dysfunction . The total PUKIN score is obtained by summing the score of the
             components. The total of each item is 0-3 while the total score of PUKI is ranging
             between 0-21 . High score indicates poor sleep quality. A total score of 5 or less is
             indicating good sleep quality, while scores above 5 indicates poor sleep quality.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Arabic version of NDIto determine the pain experience and functional disability of the participants.
  time frame: 1 month
  description: NDI consists of 10 questions concern of the pain severity, ability for personal care, lifting weight, job capability headache intensity, concentration, quality of sleeping and driving and recreation activities. Total score ranges between 0 to 50 points. Zero to four points mean "no disability", 5 to 14 points mean "light disability", 15 to 24 points mean "moderate disability", 25 to 34 points mean "severe disability", and 35 to 50 points mean "complete disability" (15).
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: 1 month
  description: In this scale consisting of 24 items, 19 items are filled in by the individual, while five items are filled in by the person's bedmate. Eighteen of the 19 items that need to be answered by the individual are scored and used to assess sleep quality, while the remaining six items are used to have clinical information. It has seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. The total PUKI score is obtained by summing the scores of the components. The total score of each component varies between zero to three and the total score of PUKI ranges from 0 to 21. High scores indicate poor sleep quality. A total score of five or less indicates good sleep quality, while scores above 5 indicate poor sleep quality (16).
  measure: Chalder Fatigue Scale (CFS)
  time frame: 1 month
  description: CFS consists of 11 questions including a 7-item physical fatigue sub-dimension and a 4-item mental fatigue sub-dimension (19). 4-point Likert scale was used. The scoring of each item varies between zero to three points. The physical fatigue sub-dimension score ranges from 0 to 21, the mental fatigue sub-dimension score ranges from 0 to 12, and the total fatigue score ranges from 0 to 33. High scores indicate a greater fatigue level (18). The arabic version of the questionnaire was used in the study (19).
  intervention type: Other
  intervention name: Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).
  description: Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  last name: zeinab Ali, phd
  role: Principal Investigator
  affiliation: Cairo University
  last name: Zeinab Ali, PHD
  phone: +201061360551
  email: zeinaboh4@gmail.com
  citation: Bonvanie IJ, Oldehinkel AJ, Rosmalen JGM, Janssens KAM. Sleep problems and pain: a longitudinal cohort study in emerging adults. Pain. 2016 Apr;157(4):957-963. doi: 10.1097/j.pain.0000000000000466.
  PMID: 26683236
  citation: Bjornsdottir SV, Jonsson SH, Valdimarsdottir UA. Mental health indicators and quality of life among individuals with musculoskeletal chronic pain: a nationwide study in Iceland. Scand J Rheumatol. 2014;43(5):419-23. doi: 10.3109/03009742.2014.881549. Epub 2014 May 12.
  PMID: 24814312
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Zeinab Abd el fattah Ali
  investigator title: assistant professor
  mesh term: Neck Pain
  mesh term: Mental Fatigue