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CTRI Number  CTRI/2025/02/080818 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Effects of Lavender Aromatherapy 
Scientific Title of Study   Effects of aromatherapy on pain and psychological parameters among orthopedic patients admitted in a tertiary care hospital, Mangaluru. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rosmy Jose 
Designation  Post Graduate Student (Nursing) 
Affiliation  Father Muller College of Nursing 
Address  Department of Medical Surgical Nursing, Father Muller College of Nursing, Father Muller Road,Kankanady, Mangaluru, Karnataka, India, 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8078864647  
Fax    
Email  rosmyjosepozholiparambil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Denitha T 
Designation  Assistant Professor 
Affiliation  Father Muller College of Nursing 
Address  Department of Medical Surgical Nursing, Father Muller College of Nursing, Father Muller Road,Kankanady, Mangaluru, Karnataka, India, 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7975123394  
Fax    
Email  denithatj@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Dr Sasikumar S 
Designation  Professor & HOD 
Affiliation  Father Muller College of Nursing 
Address  Department of Medical Surgical Nursing, Father Muller College of Nursing, Father Muller Road,Kankanady, Mangaluru, Karnataka, India, 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9620410946  
Fax    
Email  sasikrisna@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital 
 
Primary Sponsor  
Name  Rosmy Jose 
Address  Department of Medical and Surgical Nursing, Father Muller College of Nursing, Father Muller Road, Kankanady, Mangaluru, Karnataka, India, 575002 
Type of Sponsor  Other [self funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rosmy Jose  Father Muller Medical College Hospital  Department of Orthopedics, P ward and Q ward,MCH 4th floor, Father Muller Charitable Institutions, Father MUller Road, Kankanady, Mangaluru, Karnataka, India , 575002
Dakshina Kannada
KARNATAKA 		 8078864647

rosmyjosepozholiparambil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M848||Other disorders of continuity of bone,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coconut oil  Base oil (Coconut oil) is used as plcebo 5days of treatment  
Intervention  Lavender Aromatherpy  Lavender essential oil mised with base oil (coconut oil) administerd through indirect inhalation before sleep and throughout. base oil of 1% i.e. 6 drops and 2% of essential oil i.e. 12 drops is mixed during preperations will be provided for a week. 5days of intervention. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged between 20- 60 years
2.Patients who are admitted under orthopedic department of Father Muller Medical Hospital,
Mangaluru for major surgeries such as internal reductions, internal fixation and arthroplasty.
3.Patients who scored moderate and severe pain.
4.Patients who are have recovered from anesthesia and post operative day 1. 
 
ExclusionCriteria 
Details  1.Patients who have history of asthma and has nasal congestion.
2.Patients who are allergic to lavender & Lavandula angustifolia plants .
3.Patients who administered with analgesics other than PCT, diclofenac and tramadol . 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effects of lavender aromatherpy on pain and psychological parameters(stress and anxiety)  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of alternative therapy on pain & psychological parameters(stress & pain)  2 years 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   03/03/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The study is conducted to identify hoe aromatherpy make changes in orthopedic patients concerning pain and psychological parameters in orthopedic  patients  concerning pain and psychological parameters like anxiety and depression. The study included all the patients who had undergone orthopedic surgery; omissions can be made in case the patient doesn’t  agree  to participate in the study, is allergic to lavender, has respiratory chronic issues, and the age group above 60 and below 20. The group is screened by a numerical pain scale, and the patients who express a score between moderate to severe are allocated for study. Experimental and control group will be purposefully allocated. In the experimental experimental group, aromatherapy is administered with lavender essence and in control group, a placebo will be administered. Pre test will be conducted on the first day while post test will be done on the third day for pain only and the fifth day respectively. The results interpret the effects of aromatherapy  for five  days it will be  obtained through inferential statistics. 
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