<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/NCT01708031</url>
  </required_header>
  <id_info>
    <org_study_id>MAT STRESS</org_study_id>
    <nct_id>NCT01708031</nct_id>
  </id_info>
  <brief_title>Computerized Mental Arthimetic Task Based Human Stress Level Detection Using Physiological Signal</brief_title>
  <acronym>UNIMAP</acronym>
  <official_title>Computerized Mental Arthimetic Task Based Human Stress Level Detection Using Physiological Signal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Malaysia Perlis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Malaysia Perlis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Computerized Mental Arithmetic Task Based Human Stress Level Detection Using Physiological&#xD;
      Signal&#xD;
&#xD;
      The objective of this study is to induce and measure the human stress level through&#xD;
      computerized mental arithmetic task and multiple physiological signals (ECG, EMG, GSR, and&#xD;
      skin temperature). Studies suggested that mental arithmetic task is one of the efficient&#xD;
      stimuli to induce the stress. Hence, this mental arithmetic task protocol has been improved&#xD;
      in to computerized version. The protocol will be tested with normal subjects and multiple&#xD;
      physiological signals will be acquired simultaneously. The questionnaire about the subject&#xD;
      experience will be obtained in order to strengthen the stress induction. The normal volunteer&#xD;
      subjects will be invited for the participation this study. The physiological signal will be&#xD;
      analyzed using suitable algorithm based on the characteristics of each signals. The multiple&#xD;
      signal based stress level assessment system will be developed by training and testing the&#xD;
      acquired data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mental arithmetic task (MAT) is frequently used stressor to induce and assess stress by&#xD;
      efficiently. However, this method not standardized until today, it is due to different&#xD;
      environmental and psychological factors on the experimental condition. Different protocol&#xD;
      designs used in various stress assessment studies are elaborated&#xD;
&#xD;
      Previous protocol details using MAT based stress induction&#xD;
&#xD;
      (Lundberg &amp; Melin, 1994) 62 subjects &amp; SBP (Systolic Blood Pressure), DBP (Diastolic Blood&#xD;
      Pressure), Heart rate and EMG.&#xD;
&#xD;
        -  A series of addition and subtraction of 1 digit numbers.&#xD;
&#xD;
        -  Subject pronounces the answer and errors will be recorder by tape recorder.&#xD;
&#xD;
        -  Soft music was played to relax the subject and physiological and psychological&#xD;
           parameters were measured.&#xD;
&#xD;
      (Ushiyama, et al., 1991) 26 subjects, blood samples, BP and ECG. Initially, 20 minute&#xD;
      relaxation&#xD;
&#xD;
        -  7 subtractions from 700 within 2.5 min after the relaxation. Finally 3 minute&#xD;
           relaxation.&#xD;
&#xD;
        -  ECG continuous measure for complete duration&#xD;
&#xD;
        -  Blood samples, blood pressure for discrete variable only once on each task.&#xD;
&#xD;
      (Tomaka, Blascovich, &amp; Swart, 1994b) 41 subjects &amp; heart rate, skin conductance response&#xD;
      (SCR), stroke volume (SV), SBP and DBP&#xD;
&#xD;
        -  Mental arithmetic task with two type, with silent phase, and aloud phase.&#xD;
&#xD;
        -  Initially, 10 minute rest before electrode placement and 4 minutes relaxation after the&#xD;
           electrode placement and calibration.&#xD;
&#xD;
        -  Type1, rapid serial addition by 13 from 2549. Duration 4 minutes with 5 minute final&#xD;
           relaxation.&#xD;
&#xD;
        -  Type 2, rapid serial subtraction by 7 from 2549. Duration 4 minutes with 5 minute final&#xD;
           relaxation.&#xD;
&#xD;
        -  The subject is vocalizing the answer in a loud phase and silent phase subject to be&#xD;
           silent and should perform the task.&#xD;
&#xD;
      (Ring, Drayson, Walkey, Dale, &amp; Carroll, 2002) 24 subjects &amp; SBP, DBP and pulse rate.&#xD;
&#xD;
        -  4 seven minute series addition with presentation rate of 3.5, 3.0, 2.5 and 2.0s&#xD;
           respectively.&#xD;
&#xD;
        -  Addition of two sequentially presented single digit numbers (from1 to 9) in audio.&#xD;
&#xD;
        -  Answers should be retained in the memory for next addition that presented on the audio&#xD;
           tape recorder.&#xD;
&#xD;
        -  SBP, DBP and pulse rate is a discrete variable taken from a certain interval of time.&#xD;
&#xD;
      (Linden, 1991) 61 subjects &amp; DBP, SBP heart rate.&#xD;
&#xD;
        -  Four different kind noise distraction during MAT. Subtraction of 2000 from 6,7, 8,9&#xD;
           consecutively, calculation time is 5 Sec per one step.&#xD;
&#xD;
        -  Verbally pronounce the answer.&#xD;
&#xD;
        -  No noise task (the task performed without any noise).&#xD;
&#xD;
        -  Variable real life noise ( siren, car engine warm up, thunder getting closer, background&#xD;
           noise of train station etc.,).&#xD;
&#xD;
        -  Steady real life noise (coffee and bar shop background noise).&#xD;
&#xD;
        -  Variable meaningless noise task(white and pink noise).&#xD;
&#xD;
      (Von Dawans, Kirschbaum, &amp; Heinrichs, 2010) 25 subjects &amp; ECG&#xD;
&#xD;
        -  Mental arithmetic task (serial subtraction) of 8 min.&#xD;
&#xD;
        -  The task performed in between other stress inducing task.&#xD;
&#xD;
      (Seraganian, Szabo, Brown, &amp; Behavior, 1997) 20 subjects &amp; ECG.&#xD;
&#xD;
        -  11 problems requiring two serial arithmetic operations with integers (e.g., 14* 6-17).&#xD;
&#xD;
        -  Subject should perform arithmetic and also rate the difficulty level 10 point scale.&#xD;
&#xD;
        -  Task were presented in tape recorder in counter balanced order&#xD;
&#xD;
        -  Heart rate was continues measure.&#xD;
&#xD;
      Protocol design information&#xD;
&#xD;
      In this work, MAT is designed to induce and increase the stress level from one level to&#xD;
      another by creating and increasing mental demand from easy to hard. Here, the mental&#xD;
      arithmetic task is designed with audio distraction to reduce the cognition while in mental&#xD;
      demand or load. This continuous exposure is reason to induce the stress of the participants.&#xD;
      The protocol consist of 4 different levels such as relaxation with soft music, low level (low&#xD;
      difficulty), medium level (medium difficulty), high level (high difficulty). Each level has&#xD;
      30 arithmetic problem addition, subtraction, multiplication and division or combination of&#xD;
      these. Complexities of problem between levels are designed according to the low, medium, and&#xD;
      high. 10 randomly selected real time noises (generator, siren, motor sound etc) are added&#xD;
      with every 10 problems of each level in order to reduce the concentration and increase the&#xD;
      mental demand. According to the data collection environment, the noises are calibrated and&#xD;
      controlled.&#xD;
&#xD;
      Physiological measures&#xD;
&#xD;
      Non-intrusive measurement Electrocardiogram Electromyogram Galvanic skin response Skin&#xD;
      temperature Electroencephalogram&#xD;
&#xD;
      Subject information&#xD;
&#xD;
      Normal subjects and open invitation will be given to select the volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress levels assesment desinged based on the physiological signal acquired from the various subject by using MAT protocal.</measure>
    <time_frame>90 minutes</time_frame>
    <description>Selection of physiological signals&#xD;
The following four physiological signal will be acquired based on the strong clinical evidence, Non-intrusive measurement, and futuristic to develop the real time detection system using compact electronics that to reduce the obtrusive of the human in real time activities such as in job, sports application.&#xD;
Electromyogram Galvanic skin response Skin temperature</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>stress inducing task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal subjects without history medication presently will be participated. Stress induced through stress inducing task (mental arithmetic task), the physiological signals collected before and during the task simultaneously. All the subjects will be participating only once in this MAT based study. Because, the stress will not be possible to induce when the subject is more familiar with the stress inducing task.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physiological signals</intervention_name>
    <arm_group_label>stress inducing task</arm_group_label>
    <other_name>ECG</other_name>
    <other_name>EMG</other_name>
    <other_name>GSR</other_name>
    <other_name>Skin temperature</other_name>
    <other_name>EEG</other_name>
    <other_name>BP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - no histroy of disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sazali Yaacob, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unimap</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Murugappan M, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Unimap</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unimap</name>
      <address>
        <city>Kangar</city>
        <state>Perlis</state>
        <zip>02600</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Malaysia Perlis</investigator_affiliation>
    <investigator_full_name>KARTHIKEYAN PALANISAMY</investigator_full_name>
    <investigator_title>Mr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01708031
org study id: MAT STRESS
nct id: NCT01708031
lead sponsor: 
has dmc: Yes
Computerized Mental Arithmetic Task Based Human Stress Level Detection Using Physiological
      Signal

      The objective of this study is to induce and measure the human stress level through
      computerized mental arithmetic task and multiple physiological signals (ECG, EMG, GSR, and
      skin temperature). Studies suggested that mental arithmetic task is one of the efficient
      stimuli to induce the stress. Hence, this mental arithmetic task protocol has been improved
      in to computerized version. The protocol will be tested with normal subjects and multiple
      physiological signals will be acquired simultaneously. The questionnaire about the subject
      experience will be obtained in order to strengthen the stress induction. The normal volunteer
      subjects will be invited for the participation this study. The physiological signal will be
      analyzed using suitable algorithm based on the characteristics of each signals. The multiple
      signal based stress level assessment system will be developed by training and testing the
      acquired data.
Mental arithmetic task (MAT) is frequently used stressor to induce and assess stress by
      efficiently. However, this method not standardized until today, it is due to different
      environmental and psychological factors on the experimental condition. Different protocol
      designs used in various stress assessment studies are elaborated

      Previous protocol details using MAT based stress induction

      (Lundberg & Melin, 1994) 62 subjects & SBP (Systolic Blood Pressure), DBP (Diastolic Blood
      Pressure), Heart rate and EMG.

        -  A series of addition and subtraction of 1 digit numbers.

        -  Subject pronounces the answer and errors will be recorder by tape recorder.

        -  Soft music was played to relax the subject and physiological and psychological
           parameters were measured.

      (Ushiyama, et al., 1991) 26 subjects, blood samples, BP and ECG. Initially, 20 minute
      relaxation

        -  7 subtractions from 700 within 2.5 min after the relaxation. Finally 3 minute
           relaxation.

        -  ECG continuous measure for complete duration

        -  Blood samples, blood pressure for discrete variable only once on each task.

      (Tomaka, Blascovich, & Swart, 1994b) 41 subjects & heart rate, skin conductance response
      (SCR), stroke volume (SV), SBP and DBP

        -  Mental arithmetic task with two type, with silent phase, and aloud phase.

        -  Initially, 10 minute rest before electrode placement and 4 minutes relaxation after the
           electrode placement and calibration.

        -  Type1, rapid serial addition by 13 from 2549. Duration 4 minutes with 5 minute final
           relaxation.

        -  Type 2, rapid serial subtraction by 7 from 2549. Duration 4 minutes with 5 minute final
           relaxation.

        -  The subject is vocalizing the answer in a loud phase and silent phase subject to be
           silent and should perform the task.

      (Ring, Drayson, Walkey, Dale, & Carroll, 2002) 24 subjects & SBP, DBP and pulse rate.

        -  4 seven minute series addition with presentation rate of 3.5, 3.0, 2.5 and 2.0s
           respectively.

        -  Addition of two sequentially presented single digit numbers (from1 to 9) in audio.

        -  Answers should be retained in the memory for next addition that presented on the audio
           tape recorder.

        -  SBP, DBP and pulse rate is a discrete variable taken from a certain interval of time.

      (Linden, 1991) 61 subjects & DBP, SBP heart rate.

        -  Four different kind noise distraction during MAT. Subtraction of 2000 from 6,7, 8,9
           consecutively, calculation time is 5 Sec per one step.

        -  Verbally pronounce the answer.

        -  No noise task (the task performed without any noise).

        -  Variable real life noise ( siren, car engine warm up, thunder getting closer, background
           noise of train station etc.,).

        -  Steady real life noise (coffee and bar shop background noise).

        -  Variable meaningless noise task(white and pink noise).

      (Von Dawans, Kirschbaum, & Heinrichs, 2010) 25 subjects & ECG

        -  Mental arithmetic task (serial subtraction) of 8 min.

        -  The task performed in between other stress inducing task.

      (Seraganian, Szabo, Brown, & Behavior, 1997) 20 subjects & ECG.

        -  11 problems requiring two serial arithmetic operations with integers (e.g., 14* 6-17).

        -  Subject should perform arithmetic and also rate the difficulty level 10 point scale.

        -  Task were presented in tape recorder in counter balanced order

        -  Heart rate was continues measure.

      Protocol design information

      In this work, MAT is designed to induce and increase the stress level from one level to
      another by creating and increasing mental demand from easy to hard. Here, the mental
      arithmetic task is designed with audio distraction to reduce the cognition while in mental
      demand or load. This continuous exposure is reason to induce the stress of the participants.
      The protocol consist of 4 different levels such as relaxation with soft music, low level (low
      difficulty), medium level (medium difficulty), high level (high difficulty). Each level has
      30 arithmetic problem addition, subtraction, multiplication and division or combination of
      these. Complexities of problem between levels are designed according to the low, medium, and
      high. 10 randomly selected real time noises (generator, siren, motor sound etc) are added
      with every 10 problems of each level in order to reduce the concentration and increase the
      mental demand. According to the data collection environment, the noises are calibrated and
      controlled.

      Physiological measures

      Non-intrusive measurement Electrocardiogram Electromyogram Galvanic skin response Skin
      temperature Electroencephalogram

      Subject information

      Normal subjects and open invitation will be given to select the volunteers
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Stress levels assesment desinged based on the physiological signal acquired from the various subject by using MAT protocal.
time frame: 90 minutes
description: Selection of physiological signals
The following four physiological signal will be acquired based on the strong clinical evidence, Non-intrusive measurement, and futuristic to develop the real time detection system using compact electronics that to reduce the obtrusive of the human in real time activities such as in job, sports application.
Electromyogram Galvanic skin response Skin temperature
arm group label: stress inducing task
arm group type: Experimental
description: Normal subjects without history medication presently will be participated. Stress induced through stress inducing task (mental arithmetic task), the physiological signals collected before and during the task simultaneously. All the subjects will be participating only once in this MAT based study. Because, the stress will not be possible to induce when the subject is more familiar with the stress inducing task.
intervention type: Other
intervention name: physiological signals
arm group label: stress inducing task
other name: ECG
other name: EMG
other name: GSR
other name: Skin temperature
other name: EEG
other name: BP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sazali Yaacob, PhD
role: Principal Investigator
affiliation: Unimap
last name: Murugappan M, PhD
role: Study Chair
affiliation: Unimap
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Universiti Malaysia Perlis
investigator full name: KARTHIKEYAN PALANISAMY
investigator title: Mr
mesh term: Stress, Psychological