NCT06176924

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 11, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

Anxiety, tDCS, Relaxation, Competitive Exam Students, 2mA, CSAI-2R

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Active tDCS and Relaxation technique

EXPERIMENTAL

Subjects within an experimental group had received 9 sessions of tDCS (2mA, 20 min anode placed on DLFPC of left side and cathode on supraorbital cortex of right side) along with relaxation technique.

Device: tDCSOther: Relaxation technique

Relaxation technique

OTHER

Subjects in the control group are going to receive 9 sessions of relaxation technique

Other: Relaxation technique

Interventions

tDCSDEVICE

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

Active tDCS and Relaxation technique

Relaxation technique

Active tDCS and Relaxation techniqueRelaxation technique

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Competitive Exam students only.
  • Age group between 15 years to 18 years.
  • Willingness to take part in the research.

You may not qualify if:

  • Non-Corporative students
  • Skin irritation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MMIPR

Ambāla, Haryana, 133207, India

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Direct Current StimulationRelaxation Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesMind-Body TherapiesComplementary TherapiesBehavior TherapyPsychotherapy

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effect of tDCS along with relaxation technique on anxiety level in students preparing for competitive exams: A Randomized Controlled Trial

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

August 1, 2023

Primary Completion

January 10, 2024

Study Completion

February 10, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations