<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180902040927N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-07</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of tactile stimulation on cognitive functions</public_title>
      <acronym></acronym>
      <scientific_title>Effect of tactile stimulation on creative thinking ,memory and motor imagery in 18-30 year-old subjects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33767</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: simple randomization according to table of random numbers with software, Blinding description: participants were blind in this study.  The tactile stimulation device was attached to the finger of all participants, regardless of the type of group, and the participant was unaware of which group was entered. Also, in all questionnaires and computer programs, only the code was used to make the participants were unaware of the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy adults.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  30 minutes of tactile stimulation of the right index finger in one session was applied. A tactile stimulation device (Kavosh Pars Mahan Sanat Co. Iran), consisting of a control unit and stimulus modules to be connected to the hands, was used. The stimulus module has nine pins (1.5 mm height) and stimulate the right fingertip for 30 minutes (16 Hz) with the aid of a computer control system. When the tactile stimulation device was attached to the participants’ hands in both the sham and tactile stimulation groups, the subjects were not required to focus on stimulation or anything else. Intervention 2: Control group: A tactile stimulation device (Kavosh Pars Mahan Sanat Co. Iran) were attached to right index finger but the tactile stimulation device was turned off.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Azin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Rafsanjan University of Medical Sciences, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0</zip>
        <telephone>+98 34 3131 5079</telephone>
        <email>mahdieh.azin@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Azin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Rafsanjan University of Medical Sciences, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0</zip>
        <telephone>+98 34 3131 5079</telephone>
        <email>mahdieh.azin@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students of Shiraz University of Medical Sciences
The age range was between 18 and 30 years old
Right-handed according to Edinburgh's questionnaire
normal or corrected visual acuity;
Not suffering from psychiatric disorders (bipolar type 1 and schizophrenia);
Not suffering from known neurological diseases such as stroke, brain trauma, seizure and mental retardation;
Non-use of psychotherapy drugs.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  30 minutes of tactile stimulation of the right index finger in one session was applied. A tactile stimulation device (Kavosh Pars Mahan Sanat Co. Iran), consisting of a control unit and stimulus modules to be connected to the hands, was used. The stimulus module has nine pins (1.5 mm height) and stimulate the right fingertip for 30 minutes (16 Hz) with the aid of a computer control system. When the tactile stimulation device was attached to the participants’ hands in both the sham and tactile stimulation groups, the subjects were not required to focus on stimulation or anything else.</i_keyword>
      <i_keyword>Control group: A tactile stimulation device (Kavosh Pars Mahan Sanat Co. Iran) were attached to right index finger but the tactile stimulation device was turned off.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reaction time. Timepoint: Before and after tactile stimulation. Method of measurement: Hand mental rotation task with PSYTASK software.</prim_outcome>
      <prim_outcome>Response accuracy rate. Timepoint: Before and after tactile stimulation. Method of measurement: Hand mental rotation task with PSYTASK software.</prim_outcome>
      <prim_outcome>Scores of Remote Association Task. Timepoint: Before and after tactile stimulation. Method of measurement: Remote Association Task questionnaire.</prim_outcome>
      <prim_outcome>Originality of divergent thinking. Timepoint: Before and after tactile stimulation. Method of measurement: alternate uses task.</prim_outcome>
      <prim_outcome>Fluency of divergent thinking. Timepoint: Before and after tactile stimulation. Method of measurement: alternate uses task.</prim_outcome>
      <prim_outcome>Flexibility of divergent thinking. Timepoint: Before and after tactile stimulation. Method of measurement: alternate uses task.</prim_outcome>
      <prim_outcome>Elaboration of divergent thinking. Timepoint: Before and after tactile stimulation. Method of measurement: alternate uses task.</prim_outcome>
      <prim_outcome>Learning score. Timepoint: Before and after tactile stimulation. Method of measurement: Rey Auditory-Verbal Learning Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-23</approval_date>
        <contact_name>Ethics committee of rafsanjan university  of medical sciences</contact_name>
        <contact_address>Rafsanjan, Gulf Blvd., Pistachio Street,School of Medicine, Rafsanjan University of Medical Sciences (RUMS) Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
