| CTRI Number |
CTRI/2025/02/080425 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Can scalp massage with rosemary oil help reduce Generalized Anxiety Disorder and improve heart health in students |
|
Scientific Title of Study
|
Effect Of Scalp Massage With Rosemary Oil On Generalized Anxiety Disorder And Cardiovascular Parameters In Students - A Quasi Experimental Study |
| 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 Babisha L P |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor),Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7598128874 |
| Fax |
|
| Email |
babishatulips77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor),Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor),Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu - 603001 |
|
|
Primary Sponsor
|
| Name |
Dr Babisha L P |
| Address |
International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu - 603001 |
| 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 Babisha L P |
International Institute of yoga and naturopathy medical sciences, CHENGALPATTU |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor), Division:Branch I, Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU |
7598128874
babishatulips77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Scalp massage with rosemary oil |
The subjects in the group will be given scalp massage with rosemary oil for weekly 3 days for a period of 5 weeks. It will be administered in sitting position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
The students with Beck anxiety inventory scores between 8 - 25. The students with score more than 10 in Generalized Anxiety Disorder Questionnaire 7 (GAD -7). Students who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Students younger than 18 or older than 30 years. Participants with a history of cardiovascular diseases. Students with known allergy to rosemary oil. Students who have participated in a scalp massage study within the past six months. Pregnant or breastfeeding individuals. Individuals currently undergoing treatment for anxiety or taking medication that can affect cardiovascular function or anxiety levels. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety and its symptoms will be assessed using Beck Anxiety Inventory Scale(BAI), Generalized Anxiety Disorder Questionnaire 7(GAD-7). |
Anxiety and its symptoms will be assessed using Beck Anxiety Inventory Scale(BAI) and Generalized Anxiety Disorder Questionnaire 7(GAD-7) at baseline and after five weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiovascular parameters |
Cardiovascular parameters : Blood pressure & Heart Rate Variability will be assessed at baseline & after five weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2025 |
| Date of Study Completion (India) |
05/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [babishatulips77@gmail.com].
- For how long will this data be available start date provided 17-02-2025 and end date provided 15-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Anxiety is a common mental health issue characterized by feelings of nervousness,fear and trembling often accompanied by physical symptoms.It can be an early sign of other psychological disorders and in severe cases can lead to suicidal thoughts.Anxiety often goes undiagnosed making its true prevalence unknown.However,it is estimated to affect 2.1 to 5 percentage of the population in Southeast Asia,with the majority of cases occurring between the ages of 20 to 34 years. Generalized anxiety disorder is a common and often undiagnosed anxiety disorder, with a global prevalence of about 16.7 Percentage among college students.Anxiety can negatively impact students academic performance and is believed to sten from a combination of psychological factors, such as stress and trauma and genetic vulnerabilities. Current treatments of anxiety include pharmacological interventions,such as antidepressants and Cognitive behavioural therapy. However, these treatments donot always provide sufficient relief,necessitating new interventions. This study aims to investigate the effect of scalp massage with rosemary essential oil mixed with a carrier oil on students with generalized anxiety disorder. The study is based on the principles of naturopathy,which focuses on body’s self healing abilities through natural therapies.Massage and aromatherapy have been shown to promote relaxation,reduce stress hormones,and calm the nervous system. The study aims to determine whether scalp massage with rosemary essential oil offers a better approach to managing and reducing anxiety symptoms. |