| CTRI Number |
CTRI/2024/10/074749 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Aromatherapy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of Aromatherapy
Use of Aromatherapy perfumes for improving quality of sleep in cancer patients |
|
Scientific Title of Study
|
The effect of Aromatherapy on quality of sleep in cancer patients |
| 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 Sivakumar J S |
| Designation |
Post Graduate in MD Radiation oncology |
| Affiliation |
Government Arignar Anna Memorial Cancer hospital and Research Institute, Karapettai , Kanchipuram |
| Address |
Department of radiation oncology,Government Arignar Anna Memorial Cancer Hospital and Research Institute,Karapettai, Kanchipuram
Kancheepuram
TAMIL NADU
631552
India |
| Phone |
9841721004 |
| Fax |
|
| Email |
sivaisartpg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sivakumar J S |
| Designation |
Post graduate ,dept of radiation oncology |
| Affiliation |
Government Arignar Anna Memorial Cancer Hospital and Research Institute,Karapettai, Kanchipuram |
| Address |
Department of radiation oncology,Government Arignar Anna Memorial Cancer Hospital and Research Institute,Karapettai, Kanchipuram
Kancheepuram
TAMIL NADU
631552
India |
| Phone |
9841721004 |
| Fax |
|
| Email |
sivaisartpg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivasan V |
| Designation |
HOD, dept of radiation oncology |
| Affiliation |
Government Arignar Anna Memorial Cancer Hospital and Research Institute,Karapettai, Kanchipuram |
| Address |
Department of radiation oncology,Government Arignar Anna Memorial Cancer Hospital and Research Institute,Karapettai, Kanchipuram
Kancheepuram
TAMIL NADU
631552
India |
| Phone |
9444435489 |
| Fax |
|
| Email |
rt.kpm.gaamch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support by Philyra cosmetics and fragrances PTE.LTD
68, circular road
#02-01, Singapore - 049422 |
|
|
Primary Sponsor
|
| Name |
Sambodhi Mithra |
| Address |
Philyra cosmetics and fragrances PTE.LTD
68, circular road
#02-01, Singapore 049422 |
| 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 Sivakumar J S |
Government Arignar Anna Memorial Cancer Hospital and Research Institute |
M2,M500 Male wards and F2,F3,F500 wards, NH 4 Highway , Karapettai, Kancheepuram .
Kancheepuram
TAMIL NADU |
9841721004
sivaisartpg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,Chengalpattu Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy |
Patients will be demonstrated to use perfume oil by pouring 2 drops/ spraying over the pillow used by patients.
The aroma of perfume will be perceived through olfaction / inhalation.
Duration of therapy - 1 to 2 days.
Quality of sleep will be assessed by Richards Campbell sleep questionnaire on the day of study and day 1,2 post study. |
| Comparator Agent |
Control |
40 patients will be allotted and quality of sleep will be assessed by RCSQ questionnaire |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Histopathologically proven cancer patients and under treatment for cancer.
Age more than 18 years.
patients being co operative with no communication problems and staying in ward for more than 2 days. |
|
| ExclusionCriteria |
| Details |
Patients who are not willing for the study.
Patients with very poor performance status.
patients having sleep disorders and under treatment for sleep.
Patients allergic to perfumes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Aromatherapy improves the quality of sleep. |
Assessment on day of intervention,day 1 and day 2 post intervention .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aromatherapy improves latency of sleep . |
After 2 days. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
21/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
Brief Summary
Modification(s)
|
Aromatherapy is the use of aromatic plant oils applied or used in diluted form to promote wellbeing or assist with specific health concerns such as sleep,pain,stress, anxiety or nausea. Sleeplessness in cancer patients is one of the major health problems that negativity affects quality of life of patients. Aim of the study- To evaluate the effect of various perfumes ( sandal,citrus, lavender and jasmine ) in cancer patients for improving the quality of sleep. Materials and Methods - Patients of various Cancers randomised and alloted in 2 groups in our Institute. Patients characteristics will be recorded . Study group - Patients will be demonstrated to use perfume oil by pouring 2 drops/ spraying over the pillow used by patients. Quality of sleep will be assessed by Richards Campbell sleep questionnaire one day before or on the day of study and day 1,2 post study.( Sample size - 40 ,10 patients alloted per perfume) Control group - 40 patients with cancer will be assessed with Richards Campbell sleep questionnaire ( sample size -40) Study period - 6 months. Results will be published after statistical analysis.
|