Investigating the effect of ventromedial prefrontal transcranial direct current stimulation on empathy, resilience, decision-making and electroencephalography in nursing students
Investigating the effect of TDCS over vmPFC on empathy, resilience, decision-making, and QEEG of nursing students
Design
This is a double-blind parallel-group randomized clinical trial.
Settings and conduct
This study will be conducted in the community-based psychiatric care research center and the faculty of advanced medical sciences and technologies of SUMS. eligible candidate will be evaluated for resilience and empathy. Then, resting-stage EEG is recorded for 5 minutes in eyes open and eyes closed conditions. Then the person performs the Iowa decision-making task and the brain signal is recorded simultaneously. participants receive 6 sessions of TDCS with Neurostim-2 device.
Participants/Inclusion and exclusion criteria
Undergraduate and postgraduate nursing students in the age range of 18 to 40 years who do not have a history of neurological or neuropsychiatric diseases.
Intervention groups
Individuals in the intervention group will receive real stimulation. these participants will receive 20 minutes of TDCS with an intensity of 2 mA. Subjects in the control (sham) group will receive sham stimulation. For these people, stimulation with a current intensity of 2 mA is applied in the first 30 seconds of the session, but after 30 seconds, the device will be automatically turned off. The device will be placed in a space out of sight of the participants and they will not know that the device is turned off. The device will remain on people's heads for 20 minutes. Participants of both intervention and control groups will receive 6 stimulation sessions, three sessions per week for two weeks
Main outcome variables
Investigating the effect of TDCS on vmPFC on empathy, resilience, decision-making, and QEEG of nursing students
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201001048893N8
Registration date:2023-09-17, 1402/06/26
Registration timing:prospective
Last update:2023-09-17, 1402/06/26
Update count:0
Registration date
2023-09-17, 1402/06/26
Registrant information
Name
Maryam Shaygan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 7345
Email address
m2620.shaygan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of ventromedial prefrontal transcranial direct current stimulation on empathy, resilience, decision-making and electroencephalography in nursing students
Public title
Investigating the effect of transcranial direct current stimulation on empathy, resilience, decision-making, and electroencephalography in nursing students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-40 years old
Unfamiliarity with cognitive test and transcranial direct current stimulation
Not using drugs, psychedelics and cigarettes
No history of neurological diseases or psychiatric disorders
No history of brain surgery and brain tumor
Absence of metallic implants in the head
Being right-handed
Willingness to participate in the study
Exclusion criteria:
Failure to complete the treatment course
Withdrawing from the study
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be allocated to the intervention or control (sham) group randomly using randomization computer software. In this randomization method, first, a number is assigned to each patient, and then the patients' numbers will be entered into the randomization software, and this software will completely randomize the samples into one of the two groups. The randomization process will be done by someone who is not involved in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the volunteers, none of the volunteers will be aware of their allocated group (whether the real transcranial direct electrical stimulation or sham stimulation). Collecting and interpreting the questionnaire, entering and interpreting the data, and analyzing the information in statistical software will be done by a research assistant and statisticians not involved in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Zand street, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.061
Health conditions studied
1
Description of health condition studied
healthy subjects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resilience
Timepoint
Before and after six sessions of tdcs
Method of measurement
Connor-Davidson Resilience Scale
2
Description
Empathy
Timepoint
Before and after six sessions of tdcs
Method of measurement
Jefferson Scale of Empathy Health Profession Students’ version (JSPE-HPS)
3
Description
Decision making
Timepoint
Before and after six sessions of tdcs
Method of measurement
Iowa gambling task
4
Description
Electroencephalography
Timepoint
Before and after six sessions of tdcs
Method of measurement
Nr sign EEG amplifier
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving transcranial direct electrical stimulation for 20 minutes with an intensity of 2 mA per session, three sessions per week, and for two weeks, a total of 6 sessions. ________________________________________
Category
Rehabilitation
2
Description
Control group: People in this group will receive sham stimulation. For these people, stimulation with a current intensity of 2 milliamps is applied in the first 30 seconds of the session, but after 30 seconds, the device will be automatically turned off. The device will be placed in a space out of sight of the participants and they will not know that the device is turned off. The device will remain on people's heads for 20 minutes. Three sessions per week, and for two weeks, a total of 6 sessions
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University
Full name of responsible person
Dr. Maryam Shaygan
Street address
Zand street, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
cbpcrc@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Zand St., Central Building of Shiraz University of Medical Sciences, 7th floor, Vice Chancellor for Research and Technology
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Zand street, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
m2620.shaygan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3626 7345
Fax
Email
m2620.shaygan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3626 7345
Fax
Email
m2620.shaygan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Anonymous study data will be shared in correspondence with the project manager
When the data will become available and for how long
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
For including in systematic reviews only
From where data/document is obtainable
Contact via email
What processes are involved for a request to access data/document
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.