Stress, PsychologicalUNIMAPNCT01708031
Computerized Mental Arthimetic Task Based Human Stress Level Detection Using Physiological Signal
A study testing physiological signals in people with Stress, Psychological, run by Universiti Malaysia Perlis at 1 site in Malaysia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- physiological signals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- no histroy of disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Conditions
- Stress, Psychological
- Being tested
- physiological signals
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiological signalsOther
Also called ECG, EMG, GSR, Skin temperature
| Study group | Role | What they receive |
|---|---|---|
| stress inducing task | Experimental | 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. Receives: Other: physiological signals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress levels assesment desinged based on the physiological signal acquired from the various subject by using MAT protocal.
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
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Malaysia Perlis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARTHIKEYAN PALANISAMY, Universiti Malaysia Perlis
- Investigators
- Sazali Yaacob, PhD, Principal investigator, UnimapMurugappan M, PhD, Study chair, Unimap
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708031
- Sponsor's protocol ID
- MAT STRESS
- Acronym
- UNIMAP
- Status last verified
- Oct 2012
- First submitted
- 10 Oct 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Mental Arthimetic Task Based Human Stress Level Detection Using Physiological Signal
- ClinicalTrials.gov ID
- NCT01708031
- Acronym / sponsor ID
- UNIMAP / MAT STRESS
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universiti Malaysia PerlisUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stress inducing task | Experimental | Other: physiological signalsNormal 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- no histroy of disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiological signalsAlso: ECG, EMG, GSR, Skin temperature | Other | stress inducing task |
Primary outcome
Stress levels assesment desinged based on the physiological signal acquired from the various subject by using MAT protocal.
Time frame: 90 minutes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sazali Yaacob, PhD principal investigator
Unimap
Murugappan M, PhD study chair
Unimap
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiological signals in people with Stress, Psychological, run by Universiti Malaysia Perlis at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress levels assesment desinged based on the physiological signal acquired from the various subject by using MAT protocal. (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.