Effect of Bhraamaree Praanaayaama on pre- exam stress in students

Not yet recruiting

Conditions: Students going to appear for NEET for the first time and having mild to moderate stress trait anxiety as measured by STAI.

Registration Number: CTRI/2024/12/078548

Lead Sponsor: Dr. Pallavi Dattatray Nikam

Brief Summary: The study titled â€œAn open labelled two-armed randomised controlled trial to **evaluate effect of *Bhraamaree praanaayaama* on pre-exam stress** in students preparing for National Eligibility-cum-Entrance Test (NEET)â€ is an open labelled two-armed RCT.

It is designed to find that is *braamaree praanaayaama* done daily, 3 times a day, for 7 minutes each time, for a month, 4 months prior to NEET by students appearing for NEET, significantly reduces the pre-exam stress level in students, measured in terms of STAI score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV), serum level of cortisol as compared to those who do not practice?

The study population will be all students in an urban area (Nashik City or Nagpur City) who are going to appear for NEET for the first time**.**

Sampling Technique: **Simple Random Sampling** and random allocation in two groups.

Effective sample size: Total **328 subjects** assuming 10% non-response or loss of follow-up or dropout among the study subjects.

**Inclusion Criteria:**

Healthy students of age between 17-20 years and having mild to moderate stress trait anxiety as measured by STAI will be selected irrespective of gender.

**Exclusion Criteria:**

Students having severe stress trait anxiety as measured by STAI, past or present history of any psychiatric illness, premenstrual syndrome, over two weeks delay in the menstrual cycle, subjects with ear or respiratory tract infections, subjects having recent history of surgery of ear/ vocal apparatus or any other acute/chronic illness will be excluded.

Also, subjects on regular medication, especially on CNS drugs, and those practicing any form of Pranayama, Yoga, Meditation, or other relaxation techniques for the past year will be excluded.

**Withdrawal Criteria:**

If participants develop or get diagnosed with any psychological illness during the study, if they develop or get diagnosed with any disease which may worsen by intervention given during the study, if they show unwillingness for further participation or are unable to comply with study instructions or if they fail to attend an appointment after 30 days of intervention they will be withdrawn from the trial.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 328

Inclusion Criteria

Students who are going to appear for upcoming NEET for the first time (fresher) 2.
Participants who are component to give informed consent.
Students having mild to moderate stress trait anxiety as measured by STAI.

Exclusion Criteria

Severe stress trait anxiety as measured by STAI 2.
Past or present history of any psychiatric illness 3.
Premenstrual syndrome 4.
Over two weeks delay in the menstrual cycle 5.
Subjects with ear, respiratory tract infections 6.
Recent history of surgery of ear/ vocal apparatus 7.
History of any other acute/chronic illness 8.
Subjects on regular medication, especially on CNS drugs 9.
Those practicing any form of Pranayama, Yoga, Meditation or other relaxation techniques for past one year.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare change in State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both trial & control groups	Before & after intervention which will be given for 1 month
Secondary Outcomes	Before & after intervention which will be given for 1 month
1.To record State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both groups	Before & after intervention which will be given for 1 month
2.To calculate change in State Trait Anxiety Inventory (STAI) score, pulse rate, blood pressure (BP), heart rate variability (HRV) and serum level of cortisol after 1 month in both groups	Before & after intervention which will be given for 1 month

Secondary Outcome Measures

Name	Time	Method
To compare change in State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both trial & control groups	Secondary Outcomes
1.To record State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both groups	2.To calculate change in State Trait Anxiety Inventory (STAI) score, pulse rate, blood pressure (BP), heart rate variability (HRV) & serum level of cortisol after 1 month in both groups

Trial Locations

Locations (2): O.P.D. of Dept of Swasthavritta and Yoga, Matoshri Ayurved Hospital,
🇮🇳
Nashik, MAHARASHTRA, India
O.P.D. of Dept. Of Kayachikitsa, Shri Ayurved Mahavidyalaya Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
O.P.D. of Dept of Swasthavritta and Yoga, Matoshri Ayurved Hospital,
🇮🇳Nashik, MAHARASHTRA, India
Dr Pallavi Dattatray Nikam
Principal investigator
8454844613
dr.pallavinikam@yahoo.in