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/NCT06006364</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar55</org_study_id>
      <nct_id>NCT06006364</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Nomophobia on Musculoskeletal System and Sleep</brief_title>
    <official_title>Investigation of the Effect of Nomophobia on Musculoskeletal System and Sleep</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar University</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>
        The aim of this study; Investigation of the effects on the musculoskeletal system and sleep&#xD;
        by determining the nomophobia levels of individuals between the ages of 18-25.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research was planned as a quantitative research. Data collection was done online.&#xD;
  &#xD;
        The scales and forms used are as follows:&#xD;
  &#xD;
          1. Demographic Information Form&#xD;
  &#xD;
          2. Nomophobia Scale&#xD;
  &#xD;
          3. Cornell Musculoskeletal Disorder Questionnaire&#xD;
  &#xD;
          4. Smart phone Addiction Scale&#xD;
  &#xD;
          5. Pittsburgh Sleep Quality Index&#xD;
  &#xD;
          6. International Physical Activity Survey&#xD;
  &#xD;
          7. McGill Melzack Pain Questionnaire&#xD;
  &#xD;
        Questionnaires will be sent to the participants online by invitation. Participants will be&#xD;
        asked to participate in the study by reaching them through social media, mail or mobile phone&#xD;
        applications. The data obtained will be analyzed statistically.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Nomophobia Scale</measure>
      <time_frame>2 days</time_frame>
      <description>The Nomophobia Scale was itemized according to a 7-point Likert type. Out of 20 items in total consists of. The scale has four sub-dimensions: Lack of Access to Information (4 items), Losing Connection (5 items), Inability to Communicate (6 items), and Comfort Inability to feel (5 items).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cornell Musculoskeletal Disorder Questionnaire</measure>
      <time_frame>2 days</time_frame>
      <description>The questionnaire was conducted in 11 body regions (neck, right and left shoulder, upper arm, forearm and wrist, back and waist region) includes questions about the frequency of musculoskeletal disorders (pain/pain/discomfort), the severity of these disorders, and whether they interfere with work.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Smart phone Addiction Scale</measure>
      <time_frame>2 days</time_frame>
      <description>It is a scale developed to measure the risk of smart phone addiction, consisting of 10 items and evaluated with a six-point Likert scale. Scale items were scored from 1 to 6. Scale scores range from 10 to 60. As the score obtained from the test increases, it is considered that the risk for addiction increases.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>2 days</time_frame>
      <description>It is a 19-item self-report scale that evaluates sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates &quot;poor sleep quality&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire Short Form</measure>
      <time_frame>2 days</time_frame>
      <description>The questionnaire consisting of seven questions including the activities of the last seven days was prepared by the individuals themselves.&#xD;
  self-applicable and provides information about the time people spend in moderate to vigorous activities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>McGill Melzack Pain Questionnaire</measure>
      <time_frame>2 days</time_frame>
      <description>Pain Questionnaire consists of four parts. With the McGill Melzack Pain Questionnaire, the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of livable pain for the individual are determined.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Dependence</condition>
    <arm_group>
      <arm_group_label>1.Group</arm_group_label>
      <description>Nomophobia Level:none</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2.Group</arm_group_label>
      <description>Nomophobia Level: mild</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3.Group</arm_group_label>
      <description>Nomophobia Level: medium</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4.Group</arm_group_label>
      <description>Nomophobia Level: extreme</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey</intervention_name>
      <description>The scales and forms used are respectively:&#xD;
  Demographic Information Form&#xD;
  Nomophobia Scale&#xD;
  Cornell Musculoskeletal Disorder Questionnaire&#xD;
  Smart phone Addiction Scale&#xD;
  Pittsburgh Sleep Quality Index&#xD;
  International Physical Activity Survey&#xD;
  McGill Melzack Pain Questionnaire</description>
      <arm_group_label>1.Group</arm_group_label>
      <arm_group_label>2.Group</arm_group_label>
      <arm_group_label>3.Group</arm_group_label>
      <arm_group_label>4.Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          people with whom we were able to create the survey and who met the inclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To have accepted the voluntary consent form that requires participation in the survey&#xD;
               study.&#xD;
  &#xD;
            -  Being a smart phone user&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not accepting the volunteer consent form&#xD;
  &#xD;
            -  Having undergone previous surgery&#xD;
  &#xD;
            -  Being on antidepressants.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Melek ÖZCAN</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+90506 978 75 35</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Uskudar Üniversity</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer ŞEVGİN</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Bhattacharya S, Bashar MA, Srivastava A, Singh A. NOMOPHOBIA: NO MObile PHone PhoBIA. J Family Med Prim Care. 2019 Apr;8(4):1297-1300. doi: 10.4103/jfmpc.jfmpc_71_19.</citation>
      <PMID>31143710</PMID>
    </reference>
    <reference>
      <citation>Kuscu TD, Gumustas F, Rodopman Arman A, Goksu M. The relationship between nomophobia and psychiatric symptoms in adolescents. Int J Psychiatry Clin Pract. 2021 Mar;25(1):56-61. doi: 10.1080/13651501.2020.1819334. Epub 2020 Sep 17.</citation>
      <PMID>32940094</PMID>
    </reference>
    <reference>
      <citation>Notara V, Vagka E, Gnardellis C, Lagiou A. The Emerging Phenomenon of Nomophobia in Young Adults: A Systematic Review Study. Addict Health. 2021 Apr;13(2):120-136. doi: 10.22122/ahj.v13i2.309.</citation>
      <PMID>34703533</PMID>
    </reference>
    <reference>
      <citation>Rahme C, Hallit R, Akel M, Chalhoub C, Hachem M, Hallit S, Obeid S. Nomophobia and temperaments in Lebanon: Results of a national study. Perspect Psychiatr Care. 2022 Oct;58(4):1607-1612. doi: 10.1111/ppc.12968. Epub 2021 Nov 6.</citation>
      <PMID>34741546</PMID>
    </reference>
    <reference>
      <citation>Jahrami HA, Fekih-Romdhane F, Saif ZQ, Alhaj OA, AlRasheed MM, Pandi-Perumal SR, BaHammam AS, Vitiello MV. Sleep dissatisfaction is a potential marker for nomophobia in adults. Sleep Med. 2022 Oct;98:152-157. doi: 10.1016/j.sleep.2022.07.001. Epub 2022 Jul 11.</citation>
      <PMID>35868112</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 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>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>nomophobia</keyword>
    <keyword>sleep</keyword>
    <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/NCT06006364
  org study id: Uskudar55
  nct id: NCT06006364
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study; Investigation of the effects on the musculoskeletal system and sleep
        by determining the nomophobia levels of individuals between the ages of 18-25.
  The research was planned as a quantitative research. Data collection was done online.
  
        The scales and forms used are as follows:
  
          1. Demographic Information Form
  
          2. Nomophobia Scale
  
          3. Cornell Musculoskeletal Disorder Questionnaire
  
          4. Smart phone Addiction Scale
  
          5. Pittsburgh Sleep Quality Index
  
          6. International Physical Activity Survey
  
          7. McGill Melzack Pain Questionnaire
  
        Questionnaires will be sent to the participants online by invitation. Participants will be
        asked to participate in the study by reaching them through social media, mail or mobile phone
        applications. The data obtained will be analyzed statistically.
  observational model: Other
  time perspective: Prospective
  measure: Nomophobia Scale
  time frame: 2 days
  description: The Nomophobia Scale was itemized according to a 7-point Likert type. Out of 20 items in total consists of. The scale has four sub-dimensions: Lack of Access to Information (4 items), Losing Connection (5 items), Inability to Communicate (6 items), and Comfort Inability to feel (5 items).
  measure: Cornell Musculoskeletal Disorder Questionnaire
  time frame: 2 days
  description: The questionnaire was conducted in 11 body regions (neck, right and left shoulder, upper arm, forearm and wrist, back and waist region) includes questions about the frequency of musculoskeletal disorders (pain/pain/discomfort), the severity of these disorders, and whether they interfere with work.
  measure: Smart phone Addiction Scale
  time frame: 2 days
  description: It is a scale developed to measure the risk of smart phone addiction, consisting of 10 items and evaluated with a six-point Likert scale. Scale items were scored from 1 to 6. Scale scores range from 10 to 60. As the score obtained from the test increases, it is considered that the risk for addiction increases.
  measure: Pittsburgh Sleep Quality Index
  time frame: 2 days
  description: It is a 19-item self-report scale that evaluates sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".
  measure: International Physical Activity Questionnaire Short Form
  time frame: 2 days
  description: The questionnaire consisting of seven questions including the activities of the last seven days was prepared by the individuals themselves.
  self-applicable and provides information about the time people spend in moderate to vigorous activities
  measure: McGill Melzack Pain Questionnaire
  time frame: 2 days
  description: Pain Questionnaire consists of four parts. With the McGill Melzack Pain Questionnaire, the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of livable pain for the individual are determined.
  arm group label: 1.Group
  description: Nomophobia Level:none
  arm group label: 2.Group
  description: Nomophobia Level: mild
  arm group label: 3.Group
  description: Nomophobia Level: medium
  arm group label: 4.Group
  description: Nomophobia Level: extreme
  intervention type: Other
  intervention name: Survey
  description: The scales and forms used are respectively:
  Demographic Information Form
  Nomophobia Scale
  Cornell Musculoskeletal Disorder Questionnaire
  Smart phone Addiction Scale
  Pittsburgh Sleep Quality Index
  International Physical Activity Survey
  McGill Melzack Pain Questionnaire
  arm group label: 1.Group
  arm group label: 2.Group
  arm group label: 3.Group
  arm group label: 4.Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Melek ÖZCAN
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +90506 978 75 35
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Bhattacharya S, Bashar MA, Srivastava A, Singh A. NOMOPHOBIA: NO MObile PHone PhoBIA. J Family Med Prim Care. 2019 Apr;8(4):1297-1300. doi: 10.4103/jfmpc.jfmpc_71_19.
  PMID: 31143710
  citation: Kuscu TD, Gumustas F, Rodopman Arman A, Goksu M. The relationship between nomophobia and psychiatric symptoms in adolescents. Int J Psychiatry Clin Pract. 2021 Mar;25(1):56-61. doi: 10.1080/13651501.2020.1819334. Epub 2020 Sep 17.
  PMID: 32940094
  citation: Notara V, Vagka E, Gnardellis C, Lagiou A. The Emerging Phenomenon of Nomophobia in Young Adults: A Systematic Review Study. Addict Health. 2021 Apr;13(2):120-136. doi: 10.22122/ahj.v13i2.309.
  PMID: 34703533
  citation: Rahme C, Hallit R, Akel M, Chalhoub C, Hachem M, Hallit S, Obeid S. Nomophobia and temperaments in Lebanon: Results of a national study. Perspect Psychiatr Care. 2022 Oct;58(4):1607-1612. doi: 10.1111/ppc.12968. Epub 2021 Nov 6.
  PMID: 34741546
  citation: Jahrami HA, Fekih-Romdhane F, Saif ZQ, Alhaj OA, AlRasheed MM, Pandi-Perumal SR, BaHammam AS, Vitiello MV. Sleep dissatisfaction is a potential marker for nomophobia in adults. Sleep Med. 2022 Oct;98:152-157. doi: 10.1016/j.sleep.2022.07.001. Epub 2022 Jul 11.
  PMID: 35868112
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  sharing ipd: No