AnxietyNCT06176924
Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams
A study testing tDCS and Relaxation technique in people with Anxiety, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- tDCS and Relaxation technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Competitive Exam students only.
- Age group between 15 years to 18 years.
- Willingness to take part in the research.
Who cannot join
- Non-Corporative students
- Skin irritation
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
MMIPR
Ambāla, Haryana, 133207
subhasish chatterjee, MPT(NEURO), +918950037407, subhasishphysio@gmail.com
Mousumi Saha, MPT, +919366787310, msaha0029@gmail.com
About this study
Official title: Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams: A Randomized Controlled Trail
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
tDCS (2mA, 20 min anode placed on DLFPC of left side and cathode on supraorbital cortex of right side) along with relaxation technique.
Relaxation techniqueOther
Relaxation technique
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: tDCS; Other: Relaxation technique |
| Relaxation technique | Other | Subjects in the control group are going to receive 9 sessions of relaxation technique Receives: Other: Relaxation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Aug 2023
- Primary completion10 Jan 2024 (estimated)
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176924
- Sponsor's protocol ID
- SPC-PA-06
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06176924
- Acronym / sponsor ID
- SPC-PA-06
- Conditions
- Anxiety
- Keywords
- Anxiety, tDCS, Relaxation, Competitive Exam Students, 2mA, CSAI-2R
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS and Relaxation technique | Experimental | Device: tDCS, Other: Relaxation techniqueSubjects 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. |
| Relaxation technique | Other | Other: Relaxation techniqueSubjects in the control group are going to receive 9 sessions of relaxation technique |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Competitive Exam students only.
- Age group between 15 years to 18 years.
- Willingness to take part in the research.
Key exclusion criteria (2 listed)
- Non-Corporative students
- Skin irritation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCStDCS (2mA, 20 min anode placed on DLFPC of left side and cathode on supraorbital cortex of right side) along with relaxation technique. | Device | Active tDCS and Relaxation technique |
| Relaxation techniqueRelaxation technique | Other | Active tDCS and Relaxation technique, Relaxation technique |
Primary outcome
CSAI- 2R (Competitive State Anxiety Inventory-2R)
Time frame: 5 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Relaxation technique in people with Anxiety, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rama Taneja (09518260372, ramataneja.055@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSAI- 2R (Competitive State Anxiety Inventory-2R) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.