Protocol summary

Study aim
develop a cognitive readiness protocol and evaluate its effectiveness on reactivity to stress, physiological health indicators, optimal decision making and brain wave patterns.
Design
Clinical trial with control group, single blind, randomized, on 40 people. The rand function of Excel software was used for randomization
Settings and conduct
Senior military officers who will participate in the three-month period of cognitive readiness improvement plan. This course will be implemented in one of the military centers located in Tehran. Participants will be randomly assigned to two experimental and control groups (probably 20 people in each group). It should be noted that due to the implementation of the research in a military environment and also due to the commitments made to maintain confidentiality, the exact location and some of the demographic characteristics of the participants will not be disclosed.
Participants/Inclusion and exclusion criteria
Entry criteria: 30-40 years old, desire and informed consent to participate in the research Exclusion criteria: presence of mental disorders such as depression, PTST, ASD, tic disorders, anxiety disorders / presence of physical problems and diseases, including history of trauma and Head injury or the presence of brain tumors, severe sweating, skin diseases, especially on the scalp, cardiovascular and respiratory diseases / the presence of disabilities or sensory disorders that affect learning or taking tests, such as visual impairment, hearing problems Difficulty in hand movements, inability or difficulty in standing in a balanced manner
Intervention groups
The experimental group includes people who undergo 72 sessions of cognitive preparation training The control group includes people who will not receive cognitive training
Main outcome variables
stress reactivity; physiological health parameters; optimal decision making; brain wave patterns

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161213031398N2
Registration date: 2022-12-21, 1401/09/30
Registration timing: prospective

Last update: 2022-12-21, 1401/09/30
Update count: 0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Ahmad Ali Naji
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 21 7730 8591
Email address
aanaji1242@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-13, 1402/02/23
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and evaluation of the effectiveness of cognitive readiness on stress reactivity, physiological health parameters, optimal decision making and brain wave patterns
Public title
effectiveness of cognitive readiness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to participate in research Age between 30 to 40 years
Exclusion criteria:
Having mental and physical disorders High blood pressure and high blood fats Sight and hearing problems
Age
From 30 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
People volunteering to participate in the research are randomly assigned to two experimental and control groups. In this regard, a number is assigned to all the people and the people of two groups are determined by drawing lots. In this way, in simple randomization with this method, the numbers related to all sample people are first written on sheets and then placed inside the container; Then, half of the cards are drawn from the container. The removed cards are placed in the experimental group and the remaining cards are placed in the control group. Then, if the two groups were equal in terms of demographic characteristics, the assignment ends, and if not, the above process is repeated until the equality of the two groups is achieved.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are fully aware of the research objectives in their group, but they do not know which group they are in (experimental or control) and they are kept unaware of the research objectives in the other group. Also, A and B codes are sent to the analyst for intervention and control groups so that he does not know about the type of groups. Blinding of the outcome assessor will be ensured by his lack of knowledge about the allocation group of patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Semnan Province, Semnan City, Basij Boulevard, University of Medical Sciences and Healthcare Services
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
IR.SEMUMS.REC.1401.204

Health conditions studied

1

Description of health condition studied
Anxiety and stress
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
stress reactivity
Timepoint
1 and 50 days, pre-test and post-test
Method of measurement
stress reactivity questionnaire

2

Description
Physiological health indicators include body mass index (BMI), body fat index (BF), blood serum cholesterol (BSC) and systolic and diastolic blood pressure.
Timepoint
1 and 50 days, pre-test and post-test
Method of measurement
Calculating the ratio of weight to the square of height, the ratio of height and waist circumference per meter, taking 100 cc of blood, digital blood pressure monitor

3

Description
Optimal decision making using strategic management simulation
Timepoint
1 and 50 days, pre-test and post-test
Method of measurement
Using a computer simulator for 50 minutes and recording scores from reactions and decisions

4

Description
Recording of brain waves from the QEEG recording device
Timepoint
1 and 50 days, pre-test and post-test
Method of measurement
Recording of four waves of delta, theta, alpha, and beta in 19 regions of the brain

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: cognitive readiness training during 72 sessions with the headings of cognitive readiness (definition and explanation of cognitive readiness, necessity, goals and expectations, definition of skills, knowledge and insight as the main factors of cognitive readiness), situational awareness (teaching concepts related to three levels of awareness situational awareness, statement of theories of situational awareness, investigation of factors enhancing situational awareness, investigation of factors hindering situational awareness, practical exercises of situational awareness, exercise of assessing situational awareness, exercise of mindfulness with situational awareness). Metacognitive skills (step-by-step training of concepts related to metacognition. Training of cognitive strategies such as summarizing topics, taking notes and practicing retelling of content. Training of planning strategies. Training of monitoring control strategy, techniques for controlling the effectiveness of activities, searching for reasons, questioning oneself for control. self, training to adjust reaction time to social actions, training strategy including adjustment, modification or change of cognitive and emotional strategy). Problem solving skills (teaching theoretical basics based on the seven-step method). Creative thinking (teaching theoretical concepts, examining the stages of creative thinking, examining the characteristics of creative people, brainstorming technique, lotus blossom technique)
Category
Behavior

2

Description
Control group: Without effective intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
A military center in Tehran
Full name of responsible person
Ahmad Ali Naji
Street address
Block 22, Hijab St., Hakimieh, Tehran, 3rd floor, Unit 6
City
Tehran
Province
Tehran
Postal code
1659755746
Phone
+98 21 7730 8591
Email
aanaji1242@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Isaac Rahimian Boogar
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Darband, Mahdishahr, Semnan,
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 3300
Email
aanaji1242@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Isaac Rahimian Boogar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Darband, Mahdishahr, Semnan,
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 3300
Email
i_rahimian@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Isaac Rahimian Boogar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Darband, Mahdishahr, Semnan,
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 3300
Email
i_rahimian@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Ahmad Ali Naji
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Darband, Mahdishahr, Semnan,
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 21 7730 8591
Email
aanaji1242@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the military example, I do not intend to detail the data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Due to the type of research sample, it is not possible to publish individual data, but after the end of the research, the findings and data analysis will be presented in writing.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions or military centers who intend to conduct research on the protocol of cognitive preparation can benefit from the documents.
From where data/document is obtainable
Ahmad Ali Naji, aanaji1242@gmail.com
What processes are involved for a request to access data/document
1. Sending the request to the responsible person 2. Review of the applicant's proposal and research plan 3. Examining the documents and consulting with the present professors
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