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Evaluation of The effect of transcranial direct current stimulation (tDCS) On anxiety at the night before elective surgery

Protocol summary

Study aim
Determination of the effect of transcranial direct current stimulation (tDCS) on preoperative anxiety
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study is a double-blind, two-center randomized clinical trial that investigates the effect of tDCS on preoperative anxiety . According to the sample size and based on the inclusion criteria, 32 patients are admitted to the study. Using randomization method, half of the patients are in the case group and the other half are in the control group. A checklist is prepared for all patients, including social and demographic characteristics, substance abuse, previous surgical experience, knowledge of the disease, and knowledge of the type and reason for surgery. The night before the operation, the patients' anxiety level using the situational anxiety questionnaire The Spielberger Certificate (STAI) will be evaluated before and after the intervention.
Participants/Inclusion and exclusion criteria
All patients admitted to Imam Reza and Ghaem hospitals for elective cholecystectomy between the ages of 18 and 65, regardless of gender, who will be anesthetized if they meet the following conditions: Ability to read and write, Ability to speak and communicate, Right hand, no burns, lesions and tumors on the scalp, no history of brain tumors, no metal implants and pacemakers, no history of severe and recurrent headaches and head injuries,
Intervention groups
The night before the operation, the cathode electrode is placed on the right dorsolateral prefrontal cortex (DLPFC) in the case group and the anode electrode is placed on the left dorsolateral prefrontal cortex (DLPFC) with a current of 2 mA for 20 minutes.
Main outcome variables
Preoperative anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200823048494N1
Registration date: 2021-01-17, 1399/10/28
Registration timing: registered_while_recruiting

Last update: 2021-01-17, 1399/10/28
Update count: 0
Registration date
2021-01-17, 1399/10/28
Registrant information
Name
Saeed Abedin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 6180
Email address
abedins961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-25, 1399/10/05
Expected recruitment end date
2021-04-09, 1400/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The effect of transcranial direct current stimulation (tDCS) On anxiety at the night before elective surgery
Public title
The effect of transcranial direct current stimulation on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ability to write and read ability to speak and communicate being right-handed
Exclusion criteria:
history of burn history of brain tumor history of pacemaker implantation or other devices history of severe headache or head trauma history of GAD, MDD, BMD , or schizophrenia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
randomization is simple, using the randomized.com site and using a series of opaque and sealed envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients and researchers and data analyzer are blinded. after choosing the dim envelope by the patients. the envelope will be opened by health care assistants. transcranial direct current stimulation will be placed on the head of two groups of the patients, but in control group the device will turn on only for a few seconds.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
anesthesia department, Imam Reza hospital, mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2020-07-01, 1399/04/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.249

Health conditions studied

1

Description of health condition studied
pre-operative anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
pre-operative anxiety
Timepoint
night before surgery
Method of measurement
Spielberger Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The night before the operation, the cathode electrode is placed on the right dorsolateral prefrontal cortex (DLPFC) in the case group and the anode electrode is placed on the left dorsolateral prefrontal cortex (DLPFC) on the left with a current of 2 mA for 20 minutes.
Category
Prevention

2

Description
Control group: The electrodes will be in the same arrangement for the duration and amount of the test group, except that the electric current is cut off after 30 seconds.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahdi Fathi
Street address
Imam reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 2711
Email
fathim@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghoddi
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3884 9152
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Abedin
Position
Anesthesia Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza hospital, Imam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
۰۰۹۸۵۱۳۸۵۵۲۵۲۰۹
Email
abedins961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Abedin
Position
Anesthesia Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza hospital, Imam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
۰۰۹۸۵۱۳۸۵۵۲۵۲۰۹
Email
abedins961@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Abedin
Position
Anesthesia Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza hospital, Imam Reza square
City
mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
۰۰۹۸۵۱۳۸۵۵۲۵۲۰۹
Email
abedins961@mums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be published by deleting the personal details of the participants
When the data will become available and for how long
from 2022
To whom data/document is available
all the researchers
Under which criteria data/document could be used
for scientific researches only
From where data/document is obtainable
send request to correspond author fathim@mums.ac.ir
What processes are involved for a request to access data/document
send request via e-mail and explain why needs data
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