| CTRI Number |
CTRI/2026/02/103185 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study to Assess and compare the effectiveness of Mindfulness Meditation and Aerobic Exercise to Improve Physical Health and Mental Well-Being in Generation Z Health Care Students |
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Scientific Title of Study
|
Balancing Mind and Body: A Cross- Over Study on the Impact of Mindful Meditation and Aerobic Exercise on Physiological Health Markers and Psychological Well-being among Gen Z Health Care Students |
| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sasikumar S |
| Designation |
Professor HOD |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller college of Nursing Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sasikumar S |
| Designation |
Professor HOD |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller college of Nursing Mangalore
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sasikumar S |
| Designation |
Professor HOD |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller college of Nursing Mangalore
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Center Father Muller Campus Kankandy Mangalore 575002 Karnataka India |
|
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Primary Sponsor
|
| Name |
Father Muller Research Centre |
| Address |
Father Muller Research Center Father Muller Campus Kankandy Mangalore 575002 Karnataka India |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Bhat |
Father Muller Research Centre |
Father Muller Research Center
Father Muller College of Nursing
Department of Medical Surgical Nursing
Fr.Muller Hospital Campus Kankandy Mangalore 575002 Karnataka India
Dakshina Kannada
KARNATAKA |
9845084224
fmrc@fathermuller.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lipid profile Serum Cortisol Body Mass Index stress levels and mindful attention awareness |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic Exercise |
Aerobic Exercise-Will be given by Physical Instructor (CO-PI)
Duration: Aerobic Exercises 60 minutes/ day for 5 days per week
12 minutes’ warm-up, that includes stretching exercises such as arm circle, hip circle, leg swings, jumping jack and walking knee hugs followed by 30 to 40 minutes of main training.
Three major exercises carried out for 5 days/week:
Walking: is moving in a regular pace by using each foot through and completing 1000 steps (i.e.700 meters) of brisk walking at the speed of 6.5 km/hour for 10 minutes.
Climbing stairs: Repetitive movements of stepping up and down from one step to another for 10 minutes.
Cycling: Riding a stationary bicycle for 20 minutes.
Finally, 12 minutes of cool down exercises which includes stretching exercises such as seated forward bend, standing quadriceps stretch, head to knee forward bend, standing forward bend and standing cross body crunch.
|
| Intervention |
Mindfulness Based Stress Reduction |
Mindful exercises Will be given by PI (trained in mindful exercises and published in WOS, PubMed and Scopus indexed journals.
It includes four steps
-Mindfulness breathing
-Mindfulness of body sensation (Body scan)
-Mindfulness of sound
-Mindfulness of Thoughts and feeling exercises
Duration: Meditation for 45 minutes / day for 5 days per week for 8 weeks
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
First-year students who participated in Phase I
and Who stay in FMCI hostels and fall in Obesity I
Physically fit for aerobic activity
Willing to participate in both the interventions
|
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| ExclusionCriteria |
| Details |
• Students with diagnosed psychological or metabolic disorders
• Those currently undergoing similar interventions
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of a structured mindful meditation program on lipid profile, Serum Cortisol, BMI, stress levels, and mindful attention awareness.
2. To evaluate the effectiveness of a structured aerobic exercise program on lipid profile, Serum Cortisol, BMI, stress levels, and mindful attention awareness.
3. To compare the effects of mindful meditation and aerobic exercise on the selected health indicators among participants.
|
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the baseline levels of lipid profile, Serum Cortisol, BMI, stress levels, and mindful attention awareness among Gen Z health care students before the intervention. |
1 month |
|
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Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The study will be conducted in two phases which includes Phase 1 descriptive cross-sectional study with 750 samples to assess baseline data on lipid profile, BMI, stress levels, and mindful attention awareness and Phase 2 Experimental Study Using Crossover Design with 60 samples to assess and compare the effectiveness of Mindfulness-Based Intervention and Aerobic Exercise among the first-year health care students at selected institution. Universal sampling and stratified random sampling technique will be used to select the sample in the study respectively. The tool consists of three parts. The first part includes demographic proforma, the second Physiological Health markers which includes BMI, Lipid Profile and Serum Cortisol and the third Bio Psychological well-being which will be measured with standardized Perceived Stress Scale and Mindful Attention Awareness scale. The data will be analyzed by using descriptive and inferential statistics.Expected Outcome This crossover design to compare and assess their combined and individual effects on both physiological and psychological health in the Gen Z health care student population. The study’s multi-dimensional outcome assessment adds depth to the understanding of how lifestyle interventions can influence the mind–body connection. Additionally, the data which can add cultural and demographic nuance to existing global research. Using serum cortisol as a stress biomarker, which is still underused in student-focused intervention studies in India. Demonstrating the synergistic or differential effects of two holistic interventions, potentially guiding personalized approaches to student wellness programs.
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