| CTRI Number |
CTRI/2024/08/072153 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
How blue light and aromatherapy affect sleep and alertness in shift workers. |
|
Scientific Title of Study
|
EFFECT OF BLUE LIGHT THERAPY AND AROMATHERAPY ON SLEEP QUALITY AND ALERTNESS AMONG INDIVIDUAL WITH SHIFT WORK SLEEP DISORDER-A RANDOMIZED CONTROL TRAIL. |
| 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 Shalini P Y |
| Designation |
PG Scholar |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Room no -04,Deparment of Clinical Naturopathy, Alvas College of Naturopathy and Yogic Sciences , Mijar , Moodbidri , Dakshina Kannada.
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9731140116 |
| Fax |
|
| Email |
gowdashalini98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithish M K |
| Designation |
Associate Professor , Department of Naturopathy |
| Affiliation |
Alvas College of Naturopathy and Yogic sciences |
| Address |
Room no -04,Deparment of Clinical Naturopathy, Alvas College of Naturopathy and Yogic Sciences , Mijar , Moodbidri , Dakshina Kannada.
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9008331208 |
| Fax |
|
| Email |
nithi.mkhnpura@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajna |
| Designation |
Assistant Professor , Department of Naturopathy |
| Affiliation |
Alvas College of Naturopathy and Yogic sciences |
| Address |
Room no -04,Deparment of Clinical Naturopathy, Alvas College of Naturopathy and Yogic Sciences , Mijar , Moodbidri , Dakshina Kannada.
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8151824315 |
| Fax |
|
| Email |
prajnamrutha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College Of Naturopathy And Yogic Sciences , Mijar , Moodbidri , Dakshina Kannada, Karnataka, India- 574225 |
|
|
Primary Sponsor
|
| Name |
Dr Shalini P Y |
| Address |
Alvas College Of Naturopathy And Yogic Sciences , Mijar , Moodbidri , Dakshina Kannada, Karnataka, India- 574225 |
| Type of Sponsor |
Other [[Self Sponser]] |
|
|
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 Shalini PY |
Alvas Education Foundation |
Room no. 04, department of Clinical Naturopathy, Shobhavana Campus, Mijar , Moodbidre,574225
Dakshina Kannada , Karnataka
Dakshina Kannada
KARNATAKA |
9731140116
gowdashalini98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Studies of Alvas College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G472||Circadian rhythm sleep disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blue light therapy and aroma therapy |
Individual those who are working in Night shifts on the rotational basis in that those who are diagnosed as shift work sleep disorder under ICD-10 diagnostic criteria will be participating for 14 days , They will be exposed to Blue light for 30 minutes after 2 hours of waking up and
Before going to sleep individual will be exposed to lavender essential oil about 20 cm away from nose to inhale naturally . |
| Comparator Agent |
No intervention |
Control group is not given any intervention but they are asked to follow the daily routine what they were following earlier for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult with age group 18 to 50 years.
2.Both male and female.
3.Those who are working in night shifts on
rotational basis.
4.Having sound smelling sensation .
5.Willingness to participate in the study . |
|
| ExclusionCriteria |
| Details |
1. Light sensitivity , recent eye surgery eye infection .
2. Subjects who had participated in another clinical trail in previous 6 months.
3.Pregnancy
4.With other severe Primary diseases and other
co-morbid diseases.
5.Taking alcohol , smoker .
6.Having allergic rhinitis , asthma and other respiratory disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sleep quality and alertness |
Assessment done at two time points:
1. Pre-Assessment -Day 0- Before giving the intervention.
2.Post -Assessment -Day 14 -After 2 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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 Yet Recruiting |
| 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
|
Approximately a fourth of the global workforce now engages in work outside the typical daytime and nighttime rotational hours of employment. Working during nonstandard sleep and waketimes can disrupt sleep, reduce its duration, and induce drowsiness due to the conflict between the enforced sleep-wake cycle and an individual’s circadian rhythm. For most shift workers, this misalignment of the circadian rhythm is temporary, dependent on the extent of the phase shift experienced, and recovery occurs within a few days after returning to a regular sleep-wake schedule. There are multiple pharmacological interventions for the management of sleep disorders. The majority of these interventions have accompanying side effects and difficult to administer. Consequently, the objective of the current investigation is to comprehend the effectiveness of Blue light therapy and aromatherapy [lavender essential oil] in alleviating the symptoms that as quality of sleep and alertness associated with sleep disorder, with measurement of vital signs CBT/HR/R/BP and PSQI, THAT, MEQ, which is essential to assess physiological function of the subject and changes corresponding with the circadian rhythm misalignment. It is crucial to comprehend the underlying mechanisms before implementing them as therapeutic agents. In the management of circadian sleep disorder particularly shift work sleep disorder, Naturopathy employs color therapy and aromatherapy as the primary treatments which is cost effective and easy to administer by them self. Therefore, this study aimed to assess the effectiveness and implementation of both interventions on circadian sleep disorders specifically shift work sleep disorder.
This study aims to assess the effect of Blue light therapy and aromatherapy on sleep quality and alertness among adults of both genders of age group 18 -50 years with shift work sleep disorder. A total sample of 70 subjects will be included after screening and randomly divided into 2 groups where the study group (n=35) will be given cooling pranayama, and the control group (n=35) will be asked to follow their routine for a period of 14 days. Assessments will be recorded in the baseline (Day 0) and post-intervention (Day 14). |