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/NCT06041997</url>
    </required_header>
    <id_info>
      <org_study_id>CSIR-642</org_study_id>
      <nct_id>NCT06041997</nct_id>
    </id_info>
    <brief_title>Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical Trial</brief_title>
    <official_title>Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>All India Institute of Medical Sciences, New Delhi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Council of Scientific and Industrial Research, India</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>All India Institute of Medical Sciences, New Delhi</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this clinical trial is to study smartphone use restriction as a treatment&#xD;
        modality in patients of primary headache. The main question[s] it aims to answer are:&#xD;
  &#xD;
          1. In patients with primary headache, does restriction of smartphone use lead to reduced&#xD;
             consumption of medications (acute, prophylaxis, either or both)?&#xD;
  &#xD;
          2. In patients with primary headache, does restriction of smartphone use lead to better&#xD;
             responsiveness to medications (acute, prophylaxis, either or both)?&#xD;
  &#xD;
          3. Can reduction of smartphone duration be used as a non-pharmacological treatment of&#xD;
             primary headache?&#xD;
  &#xD;
          4. In patients with primary headache, is the type of smartphone use (phone calls, internet&#xD;
             browsing, watching screen) determinant of the severity of headache?&#xD;
  &#xD;
          5. Can we make an addiction score to predict which patient should be advised to limit&#xD;
             smartphone use based on the above information?&#xD;
  &#xD;
          6. In patients with primary headache, does restriction of smartphone use led to improvement&#xD;
             in headache severity (frequency, intensity, duration, one of them or all).&#xD;
  &#xD;
        The smartphone users may further be classified into low and high smartphone users depending&#xD;
        upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage score. SUs with 0-1&#xD;
        score on the SAQ were further grouped into low SUs, and patients with score ≥1 were grouped&#xD;
        into high SUs. To create a homogenous group, only patients with high SU will be randomized to&#xD;
        standard treatment (Arm C) and intervention group (Arm D).&#xD;
  &#xD;
        Participants will be asked about their smartphone usage, and if found eligible, there will be&#xD;
        a run-in period of 4 weeks after which they will be randomized to the intervention&#xD;
        (smartphone restriction) or comparison group (no restriction recommended)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Details of methodology(s):&#xD;
  &#xD;
        Patients/participants:&#xD;
  &#xD;
          1. Patients ≥18 years of age&#xD;
  &#xD;
          2. Diagnosis of primary headache as per the ICHD3Beta classification (&quot;ICHD-3 The&#xD;
             International Classification of Headache Disorders 3rd Edition&quot; n.d.)&#xD;
  &#xD;
          3. Willing and consenting to participate in the study. Patients will be first asked about&#xD;
             their smartphone use.&#xD;
  &#xD;
               -  If they do not use smartphone, they will be asked if they use any phone at all for&#xD;
                  calling, and their call durations will be recorded over the study period.&#xD;
  &#xD;
               -  If they do not use any phone, they will fall in the external control group (Arm A).&#xD;
                  if the patient uses a feature phone, but not a smartphone, he/she will be in&#xD;
                  another external control group (Arm B)&#xD;
  &#xD;
               -  If they use smartphone their use will be recorded over the study period in terms&#xD;
                  of:&#xD;
  &#xD;
                  o Screen use: Social network/testing/gaming/surfing/reading/music/video&#xD;
  &#xD;
               -  The smartphone users may further be classified into low and high smartphone users&#xD;
                  depending upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage&#xD;
                  score. SUs with 0-1 score on the SAQ were further grouped into low SUs, and&#xD;
                  patients with score ≥1 were grouped into high SUs. To create a homogenous group,&#xD;
                  only patients with high SU will be randomized to standard treatment (Arm C) and&#xD;
                  intervention group (Arm D).&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        Patients with headache with history of high smartphone use will be randomized into&#xD;
        restriction and no-restriction arm.&#xD;
  &#xD;
        Restriction method:&#xD;
  &#xD;
        In the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of&#xD;
        number of overall use. The patients will then be advised to cut down the usage by one-third&#xD;
        in terms of usage hours. The compliance will be checked at the time of outcome assessment.&#xD;
  &#xD;
        Comparison:&#xD;
  &#xD;
        In the non-intervention group only the smartphone usage data will be collected in the study&#xD;
        period. The non-smartphone users will be as another control arm.&#xD;
  &#xD;
        Outcome:&#xD;
  &#xD;
        Primary:&#xD;
  &#xD;
        The number of times the patient is using acute pain medications for headache in one month,&#xD;
        three months after initiation of study period.&#xD;
  &#xD;
        Secondary:&#xD;
  &#xD;
          1. The frequency of headache over a period of one month, three months after the initiation&#xD;
             of study period in the intervention versus control group.&#xD;
  &#xD;
          2. The number of prophylaxis medications being taken three months after the initiation of&#xD;
             study period in the intervention versus control group.&#xD;
  &#xD;
        Timeline of measuring outcome:&#xD;
  &#xD;
        The follow up will be over a period of 20 weeks after screening eligibility and 16 weeks&#xD;
        after randomization. The patient will maintain a headache diary in which he/she will enter&#xD;
        the number of times they needed to take rescue medication.&#xD;
  &#xD;
        Monitoring and assessment timeline Week 0 Week 4 Week 16 Week 20 Screening for eligibility X&#xD;
        Randomization X Smartphone usage hours X X X Acute medications log X X X Headache&#xD;
        episodes/month X X X Prophylaxis medication log X X X&#xD;
  &#xD;
        Details of salient/novelty features (You can add multiple references by clicking ADD More&#xD;
        button):&#xD;
  &#xD;
        Salient features:&#xD;
  &#xD;
          1. No study done so far on the longitudinal association of headache characteristics in&#xD;
             smartphone and non-smartphone users.&#xD;
  &#xD;
          2. The study will document the smartphone use in various aspects in patients with headache&#xD;
             and analyze the evolution of time to study the temporal relationship of smartphone use&#xD;
             in patients with primary headache.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The pill burden for abortive treatment</measure>
      <time_frame>three months after initiation of study period</time_frame>
      <description>The number of times the patient is using acute pain medications for headache in one month</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Headache frequency</measure>
      <time_frame>One and three months</time_frame>
      <description>The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of prophylactic medication</measure>
      <time_frame>Three months</time_frame>
      <description>The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Headache Disorders</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with headache with history of high smartphone use will be randomized into restriction and no-restriction arm.&#xD;
  Restriction method:&#xD;
  In the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of number of overall use. The patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Comparison:&#xD;
  In the non-intervention group only the smartphone usage data will be collected in the study period. The non-smartphone users will be as another control arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Smartphone restriction</intervention_name>
      <description>The patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients ≥18 years of age&#xD;
  &#xD;
            2. Diagnosis of primary headache as per the ICHD3Beta classification (&quot;ICHD-3 The&#xD;
               International Classification of Headache Disorders 3rd Edition&quot; n.d.)&#xD;
  &#xD;
            3. Willing and consenting to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Secondary headaches 2. Not consenting for participation or follow up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Deepti Vibha</last_name>
      <phone>+911126594485</phone>
      <email>deeptivibha@aiims.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rajesh Singh</last_name>
      <phone>+911126594049</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Deepti Vibha</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110029</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Deepti Vibha</last_name>
        <phone>+91-011-26594485</phone>
        <email>deeptivibha@aiims.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
      <investigator_full_name>Deepti Vibha</investigator_full_name>
      <investigator_title>Dr Deepti Vibha</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Headache Disorders</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Anonymized data will be shared on reasonable request</ipd_description>
    </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/NCT06041997
  org study id: CSIR-642
  nct id: NCT06041997
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to study smartphone use restriction as a treatment
        modality in patients of primary headache. The main question[s] it aims to answer are:
  
          1. In patients with primary headache, does restriction of smartphone use lead to reduced
             consumption of medications (acute, prophylaxis, either or both)?
  
          2. In patients with primary headache, does restriction of smartphone use lead to better
             responsiveness to medications (acute, prophylaxis, either or both)?
  
          3. Can reduction of smartphone duration be used as a non-pharmacological treatment of
             primary headache?
  
          4. In patients with primary headache, is the type of smartphone use (phone calls, internet
             browsing, watching screen) determinant of the severity of headache?
  
          5. Can we make an addiction score to predict which patient should be advised to limit
             smartphone use based on the above information?
  
          6. In patients with primary headache, does restriction of smartphone use led to improvement
             in headache severity (frequency, intensity, duration, one of them or all).
  
        The smartphone users may further be classified into low and high smartphone users depending
        upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage score. SUs with 0-1
        score on the SAQ were further grouped into low SUs, and patients with score ≥1 were grouped
        into high SUs. To create a homogenous group, only patients with high SU will be randomized to
        standard treatment (Arm C) and intervention group (Arm D).
  
        Participants will be asked about their smartphone usage, and if found eligible, there will be
        a run-in period of 4 weeks after which they will be randomized to the intervention
        (smartphone restriction) or comparison group (no restriction recommended)
  Details of methodology(s):
  
        Patients/participants:
  
          1. Patients ≥18 years of age
  
          2. Diagnosis of primary headache as per the ICHD3Beta classification ("ICHD-3 The
             International Classification of Headache Disorders 3rd Edition" n.d.)
  
          3. Willing and consenting to participate in the study. Patients will be first asked about
             their smartphone use.
  
               -  If they do not use smartphone, they will be asked if they use any phone at all for
                  calling, and their call durations will be recorded over the study period.
  
               -  If they do not use any phone, they will fall in the external control group (Arm A).
                  if the patient uses a feature phone, but not a smartphone, he/she will be in
                  another external control group (Arm B)
  
               -  If they use smartphone their use will be recorded over the study period in terms
                  of:
  
                  o Screen use: Social network/testing/gaming/surfing/reading/music/video
  
               -  The smartphone users may further be classified into low and high smartphone users
                  depending upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage
                  score. SUs with 0-1 score on the SAQ were further grouped into low SUs, and
                  patients with score ≥1 were grouped into high SUs. To create a homogenous group,
                  only patients with high SU will be randomized to standard treatment (Arm C) and
                  intervention group (Arm D).
  
        Intervention:
  
        Patients with headache with history of high smartphone use will be randomized into
        restriction and no-restriction arm.
  
        Restriction method:
  
        In the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of
        number of overall use. The patients will then be advised to cut down the usage by one-third
        in terms of usage hours. The compliance will be checked at the time of outcome assessment.
  
        Comparison:
  
        In the non-intervention group only the smartphone usage data will be collected in the study
        period. The non-smartphone users will be as another control arm.
  
        Outcome:
  
        Primary:
  
        The number of times the patient is using acute pain medications for headache in one month,
        three months after initiation of study period.
  
        Secondary:
  
          1. The frequency of headache over a period of one month, three months after the initiation
             of study period in the intervention versus control group.
  
          2. The number of prophylaxis medications being taken three months after the initiation of
             study period in the intervention versus control group.
  
        Timeline of measuring outcome:
  
        The follow up will be over a period of 20 weeks after screening eligibility and 16 weeks
        after randomization. The patient will maintain a headache diary in which he/she will enter
        the number of times they needed to take rescue medication.
  
        Monitoring and assessment timeline Week 0 Week 4 Week 16 Week 20 Screening for eligibility X
        Randomization X Smartphone usage hours X X X Acute medications log X X X Headache
        episodes/month X X X Prophylaxis medication log X X X
  
        Details of salient/novelty features (You can add multiple references by clicking ADD More
        button):
  
        Salient features:
  
          1. No study done so far on the longitudinal association of headache characteristics in
             smartphone and non-smartphone users.
  
          2. The study will document the smartphone use in various aspects in patients with headache
             and analyze the evolution of time to study the temporal relationship of smartphone use
             in patients with primary headache.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The pill burden for abortive treatment
  time frame: three months after initiation of study period
  description: The number of times the patient is using acute pain medications for headache in one month
  measure: Headache frequency
  time frame: One and three months
  description: The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
  measure: Number of prophylactic medication
  time frame: Three months
  description: The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.
  arm group label: Intervention
  arm group type: Experimental
  description: Patients with headache with history of high smartphone use will be randomized into restriction and no-restriction arm.
  Restriction method:
  In the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of number of overall use. The patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.
  arm group label: Control
  arm group type: No Intervention
  description: Comparison:
  In the non-intervention group only the smartphone usage data will be collected in the study period. The non-smartphone users will be as another control arm.
  intervention type: Behavioral
  intervention name: Smartphone restriction
  description: The patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Deepti Vibha
  phone: +911126594485
  email: deeptivibha@aiims.edu
  last name: Rajesh Singh
  phone: +911126594049
  facility: 
  status: Recruiting
  contact: 
  country: India
  responsible party type: Principal Investigator
  investigator affiliation: All India Institute of Medical Sciences, New Delhi
  investigator full name: Deepti Vibha
  investigator title: Dr Deepti Vibha
  mesh term: Headache Disorders
  mesh term: Headache
  sharing ipd: Undecided
  ipd description: Anonymized data will be shared on reasonable request