| CTRI Number |
CTRI/2025/12/098294 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of blue light on stress |
|
Scientific Title of Study
|
Effect of blue light exposure on autonomic functions and perceived stress among medical students: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandana A |
| Designation |
MD Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire, Belthangady, Dakshina Kannada 5742040
Dakshina Kannada
KARNATAKA
5742040
India |
| Phone |
7619615851 |
| Fax |
|
| Email |
chandanaaravind789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana A |
| Designation |
MD Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire, Belthangady, Dakshina Kannada 5742040
KARNATAKA
5742040
India |
| Phone |
7619615851 |
| Fax |
|
| Email |
chandanaaravind789@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha K J |
| Designation |
Professor of Naturopathy and Yoga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire, Belthangady, Dakshina Kannada 5742040
Dakshina Kannada
KARNATAKA
5742040
India |
| Phone |
9480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shanthivana, Dharmasthala, Belthangady, Dakshina Kannada - 574240 |
|
|
Primary Sponsor
|
| Name |
Dr Chandana A |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire, Belthangady, Dakshina Kannada 5742040 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandana A |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science |
COE, Department of Natural Therapeutic
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science, Ujire, Belthangady, Dakshina Kannada 5742040
Dakshina Kannada
KARNATAKA |
7619615851
chandanaaravind789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic Science Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blue light exposure |
Subjects will lie in the supine position, with minimal comfortable clothing and gaze at the ceiling-mounted blue LED light strip of wavelength 470 to 480nm and eye level lux of 220 to 250lux, for a duration of 20 minutes, 5 days a week for 4 continuous weeks |
| Comparator Agent |
White light exposure |
Subjects will lie in the supine position, with minimal comfortable clothing and gaze at the ceiling-mounted white LED light strip of eye level lux of 220 to 250lux and color temperature 4000 to 5000K, for a duration of 20 minutes, 5 days a week, for 4 continuous weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects willing to participate after signing the informed consent form
2. Individuals with moderate to high perceived stress (PSS 10 more than or equal to 14)
3. With normal or corrected to normal vision
|
|
| ExclusionCriteria |
| Details |
1. Students with a history of Cardiovascular diseases, Chronic autonomic dysfunctions, Neurological disorders (e.g., epilepsy, migraine), Severe psychiatric illnesses
2. Current use of autonomic-modulating medications, antidepressants, sedatives, or beta-blockers.
3. Participants with color blindness or visual impairments affecting color perception.
4. Students with a history of photosensitivity or light-triggered headaches/seizures.
5. Individuals involved in night-shift work or with severe irregular sleep schedules.
6. Individuals habituated to coffee, tea, smoking, or alcohol
7. Ongoing participation in any other clinical or stress management intervention (e.g., psychotherapy, light therapy, active relaxation protocols).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived stress, Heart rate variability, and galvanic skin response |
Pre assessment (baseline)
Post assessment (post one month of intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the percentage change in the time and frequency domains of the HRV
To correlate the changes in the heart rate variability with the changes in the perceived stress
Blood pressure and heart rate changes |
Pre assessment (baseline)
Post assessment (post one month of intervention) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="0"
Months="6"
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
|
|
Brief Summary
|
Color therapy is a traditional naturopathic healing modality that employs the therapeutic application of specific colors to restore physiological and psychological balance. Based on the principle that colors carry specific vibrational frequencies that interact with the human biofield and influence bodily functions. In naturopathy, it is believed that exposure to a particular color, either through visual gazing, ambient lighting, or direct skin exposure, can harmonize internal organ systems and regulate autonomic balance. The majority of research has either used visual exposure alone or ambient lighting, with limited investigation into combined modalities involving both visual gazing and simultaneous skin exposure over a longitudinal duration. Furthermore, studies assessing these effects specifically in high-stress academic populations, such as medical students who are known to experience elevated perceived stress and reduced autonomic flexibility compared to their non-medical peers, are scarce. This study explores the cumulative effects of chromotherapy on autonomic modulation and stress resilience in a vulnerable group
Eligibility to participate would be screened through the PSS 10 questionnaire, with individuals with a score more than or equal to 14 and a negative Ishihara test would be included
Grouping - 70 individuals - divided into 2 equal groups Group A (intervention): blue light exposure (n = 35) Group B (control): white light exposure (n = 35)
Assessments -The HRV, GSR, and HR would be assessed continuously for a total duration of 25 minutes, during which the assessment would be divided into pre-stressor ( 7 minutes), 7 minutes during stressor (MAT - mental arithmetic task) and 10 minutes during the recovery phase post stressor. This procedure will be repeated twice - once before the intervention and again 4 weeks after the chromotherapy intervention.
Intervention Group A - blue light (20 minutes) - 5 days a week for 4 weeks Group B - white light (20 minutes) - 5 days a week for 4 weeks
|