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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06176924
Other study ID # SPC-PA-06
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date February 10, 2024

Study information

Verified date December 2023
Source Maharishi Markendeswar University (Deemed to be University)
Contact Rama Taneja
Phone 09518260372
Email ramataneja.055@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anxiety is one of the most significant obstacles to academic success. When stress is interpreted negatively or becomes overwhelming, it causes anxiety before and during examinations, which in turn impacts students' academic performance. The difficulty in managing severely associated anxiousness enhances the demand for NIBS. It is a unique approach that has the potential to alleviate anxiety by modifying cortical excitability whereas Relaxation breaks the vicious cycle of pain caused by muscular stress, circulatory illness, and metabolic by-products alterations. The main purpose is to evaluate whether tDCS along with Relaxation technique reduces the anxiety level in competitive exam students. Total 46 students are recruited and randomly allocating in experimental and control group. The subjects in the experimental group are going to receive 9 tDCS sessions (2mA, anode placed on the DLFPC of left side and cathode on right supraorbital cortex for 20 min) along with relaxation technique. Subjects in the control group are going to receive 9 sessions of relaxation. The CSAI-2R scale is used as an Outcome Measure. Samples completed the CSAI-2R scale before and following the intervention. The data will be analyzed using SPSS 26.0 software.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date February 10, 2024
Est. primary completion date January 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 18 Years
Eligibility Inclusion Criteria: • Both male and female students. - Competitive Exam students only. - Age group between 15 years to 18 years. - Willingness to take part in the research. Exclusion Criteria: • Seizure disorder - Non-Corporative students - Skin irritation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS
tDCS (2mA, 20 min anode placed on DLFPC of left side and cathode on supraorbital cortex of right side) along with relaxation technique.
Other:
Relaxation technique
Relaxation technique

Locations

Country Name City State
India MMIPR Ambala Haryana

Sponsors (1)

Lead Sponsor Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary CSAI- 2R (Competitive State Anxiety Inventory-2R) It is a reliable and viable scale for assessing the level of competitive anxiety. It's having 27 components, each having 4 grades ranging from 1 to 4. 5 minutes
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