| CTRI Number |
CTRI/2024/09/073912 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of aromatherapy with bitter orange essential oil as compared to distilled water to reduce pain among the upper arm fracture post-operative orthopedic patients: A double-blinded randomized controlled trial. |
|
Scientific Title of Study
|
Efficacy of aromatherapy with Citrus aurantium essential oil as compared to placebo in reducing pain level among the upper limb fracture post-operative orthopedic patients: A double-blinded 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 |
Chumdeno Tungoe |
| Designation |
M.Sc Medical Surgical Nursing student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006 |
| Address |
M.Sc Medical Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry-605006.
Room No: 306, Nightingale House, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9863000281 |
| Fax |
|
| Email |
chumdenotungoe08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MJ Kumari |
| Designation |
Professor cum Principal (acting) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry-605006. |
| Address |
Department of Medical Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry-605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MJ Kumari |
| Designation |
Professor cum Principal (acting) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry-605006. |
| Address |
Department of Medical Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry-605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chumdeno Tungoe |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry. |
Room no 3040.Orthopedic Department.
Pondicherry
PONDICHERRY |
9863000281
chumdenotungoe08@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Human Studies, Jawaharlal Institute of postgraduate Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Citrus aurantium essential oil. |
Patients in the intervention group will be given 4 drops of Citrus aurantium essential oil (in a nasal inhaler) at the 24th, 48th and 72nd hour after surgery and asked to inhale for 30 minutes. |
| Comparator Agent |
Distilled water. |
Patients in the control group will be given 4 drops of distilled water (in a nasal inhaler) at the 24th, 48th and 72nd hour after surgery and asked to inhale for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will undergo upper limb fracture orthopedic surgery.
Patients who will be fully alert after recovering from anesthesia.
Patients who will be able to self-report a normal sense of smell.
Patients who will be able to visualize VAS for pain intensity.
Patients whose VAS is less than or equal to 7 (mild to moderate)
Patients who have not received analgesic within 2 hours of aromatherapy administration.
Patients with negative allergy test.
Patients between 18 and 65 years of age.
|
|
| ExclusionCriteria |
| Details |
Patients having postoperative complications (such as hemorrhage and hematoma)
Patients who need oxygen therapy.
Patients who have epidural analgesia (nerve block)
Patients with nasal blocks.
Patients who have a known history of allergy to any essential oils
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of aromatherapy with Citrus aurantium essential oil as compared to placebo in reducing pain levels among upper limb fracture post-operative orthopedic patients. |
At 24, 48 and 72 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
30/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a double-blinded randomized trial to assess the efficacy of Citrus aurantium essential oil as compared to placebo (distilled water) in reducing pain level among the upper limb fracture post-operative orthopedic patients. Patients who met the inclusion criteria were enrolled after an allergy test using convenient sampling with randomization. The procedure was performed at 24th, 48th and 72nd hour post surgery. Initial data for every participant was collected before the beginning of the procedure: demographic data and VAS score. Both the researcher and participant were blinded in the study to avoid bias and to ensure reliability. |