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/NCT06009081</url>
    </required_header>
    <id_info>
      <org_study_id>E-10840098-772.02-4942</org_study_id>
      <nct_id>NCT06009081</nct_id>
    </id_info>
    <brief_title>Interventions For Neck Pain In Relation to Internet Usage</brief_title>
    <official_title>A Comparıson Of Different Interventions For Neck Paın In Relation to Internet Usage Rates</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        After the rapid increase in the use of the Internet in the world, it has brought some&#xD;
        negativities.People with internet addiction describe all the time they spend without internet&#xD;
        as worthless and they want to be on the internet with an increasing desire.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Under all this information, the exercise program and walking programs that are easily added&#xD;
        to people's lives in the study; The effects on stress and sleep levels were investigated by&#xD;
        reducing neck pain symptoms in people with internet addiction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">October 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 18, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Physiotherapists who perform and evaluate the practice are different people.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>internet addiction scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>Young's internet addiction scale is a 20-question self-report scale developed by Young. There are answers to the questions as &quot;Never&quot;, &quot;Rarely&quot;, &quot;Sometimes&quot;, &quot;Often&quot;, &quot;Very often&quot;, &quot;Constantly&quot;. According to the survey; He was defined as &quot;Internet addict&quot; when he scored 80 and above</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disability Index</measure>
      <time_frame>8 weeks</time_frame>
      <description>The Neck Disability Index is a frequently used scale to evaluate neck disability in the clinic. Pain intensity assesses perceived neck pain in personal care, lifting, reading, headaches, concentration, work, driving, sleep, and leisure activities. It was determined as &quot;0&quot; as the best and &quot;50&quot; as the worst</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical Activity Index</measure>
      <time_frame>8 weeks</time_frame>
      <description>The International Physical Activity Index, developed to measure the physical activity levels of individuals aged 15-65, asks questions about their physical activity in the last 7 days.It has three categories: Inactive (Category 1), Minimally Active (Category 2), Very Active (Category 3).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>stress scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>Perceived stress scale, this scale is used to measure stress perceptions. In this scale, which has 14 questions in total, the answers are &quot;Never&quot;, &quot;Almost never&quot;, &quot;Sometimes&quot;, &quot;Quite often&quot;, &quot;Very often&quot;. In this test, the lowest &quot;0&quot; and the highest &quot;56&quot; points can be obtained; high values indicate the height of the stress perceived by the person .</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep Quality Index</measure>
      <time_frame>8 weeks</time_frame>
      <description>Pittsburgh Sleep Quality Index, developed by Buysse et al. in 1989, consists of 24 questions evaluating sleep status in the last 1 month. A minimum score of 21 is obtained. High scores indicate poor sleep quality</description>
    </primary_outcome>
    <primary_outcome>
      <measure>anxiety scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>The Beck anxiety scale consists of four options as &quot;Never&quot;, &quot;Mild&quot;, &quot;Moderate&quot;, &quot;Severe&quot; considering the questionnaire responses in the last week. This scale, which has a score between 0-63 points, evaluates the symptoms of anxiety and is calculated as 63 points for the worst result. If the results are lower than 21, it indicates mild anxiety, 22-35 indicates moderate anxiety, and higher than 36 indicates severe anxiety</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Internet Addiction</condition>
    <arm_group>
      <arm_group_label>postural exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An 8-week home exercise program consisting of neck exercises was applied for group 1. The exercise program was carried out three times a week for eight weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>aerobic exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>An 8-week walking program was planned for Group 2 using pedometer feedback as a motivational tool.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>postural exercise</intervention_name>
      <description>The exercises consisted of 4-way neck isometric exercises and stretching exercises for the activation of deep cervical flexors (chin tuck exercise) and combined with this exercise. This protocol consisted of protocols studied in similar studies.</description>
      <arm_group_label>postural exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>aerobic exercise</intervention_name>
      <description>The walking program was carried out daily on a flat surface with a target of 7000 steps. This goal is based on the American College of Sports Medicine reports on the minimum recommended levels of physical activity required to achieve health benefits, which includes several design elements.</description>
      <arm_group_label>aerobic exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  20 and 25 years old, have internet addiction&#xD;
  &#xD;
            -  have neck pain complaints for more than three months&#xD;
  &#xD;
            -  low category according to the International Physical Activity Index.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who had mobility limitations and neurological problems -had spinal&#xD;
               surgery, had a traffic accident in the last three months and were injured by whiplash&#xD;
               injury mechanism- visual and hearing impairments,&#xD;
  &#xD;
            -  refused to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Months</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>HAZAL genç, PhD</last_name>
      <phone>05413204291</phone>
      <email>hazaloksuz@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>gamze demircioğlu, PhD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>HAZAL genç</name>
        <address>
          <city>Istanbul</city>
          <state>None Selected</state>
          <zip>34353</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>HAZAL genç, phd</last_name>
        <phone>05413204291</phone>
        <email>hazaloksuz@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Zhang X, Yang H, Zhang K, Zhang J, Lu X, Guo H, Yuan G, Zhu Z, Du J, Shi H, Jin G, Hao J, Sun Y, Su P, Zhang Z. Effects of exercise or tai chi on Internet addiction in college students and the potential role of gut microbiota: A randomized controlled trial. J Affect Disord. 2023 Apr 14;327:404-415. doi: 10.1016/j.jad.2023.02.002. Epub 2023 Feb 6.</citation>
      <PMID>36754096</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>hazal genc</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>addiction</keyword>
    <keyword>internet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neck Pain</mesh_term>
      <mesh_term>Behavior, Addictive</mesh_term>
      <mesh_term>Internet Addiction Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06009081
  org study id: E-10840098-772.02-4942
  nct id: NCT06009081
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  After the rapid increase in the use of the Internet in the world, it has brought some
        negativities.People with internet addiction describe all the time they spend without internet
        as worthless and they want to be on the internet with an increasing desire.
  Under all this information, the exercise program and walking programs that are easily added
        to people's lives in the study; The effects on stress and sleep levels were investigated by
        reducing neck pain symptoms in people with internet addiction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: Physiotherapists who perform and evaluate the practice are different people.
  measure: internet addiction scale
  time frame: 8 weeks
  description: Young's internet addiction scale is a 20-question self-report scale developed by Young. There are answers to the questions as "Never", "Rarely", "Sometimes", "Often", "Very often", "Constantly". According to the survey; He was defined as "Internet addict" when he scored 80 and above
  measure: Disability Index
  time frame: 8 weeks
  description: The Neck Disability Index is a frequently used scale to evaluate neck disability in the clinic. Pain intensity assesses perceived neck pain in personal care, lifting, reading, headaches, concentration, work, driving, sleep, and leisure activities. It was determined as "0" as the best and "50" as the worst
  measure: Physical Activity Index
  time frame: 8 weeks
  description: The International Physical Activity Index, developed to measure the physical activity levels of individuals aged 15-65, asks questions about their physical activity in the last 7 days.It has three categories: Inactive (Category 1), Minimally Active (Category 2), Very Active (Category 3).
  measure: stress scale
  time frame: 8 weeks
  description: Perceived stress scale, this scale is used to measure stress perceptions. In this scale, which has 14 questions in total, the answers are "Never", "Almost never", "Sometimes", "Quite often", "Very often". In this test, the lowest "0" and the highest "56" points can be obtained; high values indicate the height of the stress perceived by the person .
  measure: Sleep Quality Index
  time frame: 8 weeks
  description: Pittsburgh Sleep Quality Index, developed by Buysse et al. in 1989, consists of 24 questions evaluating sleep status in the last 1 month. A minimum score of 21 is obtained. High scores indicate poor sleep quality
  measure: anxiety scale
  time frame: 8 weeks
  description: The Beck anxiety scale consists of four options as "Never", "Mild", "Moderate", "Severe" considering the questionnaire responses in the last week. This scale, which has a score between 0-63 points, evaluates the symptoms of anxiety and is calculated as 63 points for the worst result. If the results are lower than 21, it indicates mild anxiety, 22-35 indicates moderate anxiety, and higher than 36 indicates severe anxiety
  arm group label: postural exercise
  arm group type: Experimental
  description: An 8-week home exercise program consisting of neck exercises was applied for group 1. The exercise program was carried out three times a week for eight weeks.
  arm group label: aerobic exercise
  arm group type: Active Comparator
  description: An 8-week walking program was planned for Group 2 using pedometer feedback as a motivational tool.
  intervention type: Behavioral
  intervention name: postural exercise
  description: The exercises consisted of 4-way neck isometric exercises and stretching exercises for the activation of deep cervical flexors (chin tuck exercise) and combined with this exercise. This protocol consisted of protocols studied in similar studies.
  arm group label: postural exercise
  intervention type: Behavioral
  intervention name: aerobic exercise
  description: The walking program was carried out daily on a flat surface with a target of 7000 steps. This goal is based on the American College of Sports Medicine reports on the minimum recommended levels of physical activity required to achieve health benefits, which includes several design elements.
  arm group label: aerobic exercise
  criteria: 
  gender: All
  minimum age: 20 Months
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: HAZAL genç, PhD
  phone: 05413204291
  email: hazaloksuz@gmail.com
  last name: gamze demircioğlu, PhD
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Zhang X, Yang H, Zhang K, Zhang J, Lu X, Guo H, Yuan G, Zhu Z, Du J, Shi H, Jin G, Hao J, Sun Y, Su P, Zhang Z. Effects of exercise or tai chi on Internet addiction in college students and the potential role of gut microbiota: A randomized controlled trial. J Affect Disord. 2023 Apr 14;327:404-415. doi: 10.1016/j.jad.2023.02.002. Epub 2023 Feb 6.
  PMID: 36754096
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: hazal genc
  investigator title: Principal Investigator
  mesh term: Neck Pain
  mesh term: Behavior, Addictive
  mesh term: Internet Addiction Disorder
  sharing ipd: No