- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456657
Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis (LAM-RA)
The Effect of Lavender Aromatherapy Massage on Pain Intensity and Wrist Joint Mobility in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rheumatoid arthritis is a chronic autoimmune inflammatory disease characterized by joint pain, stiffness, and reduced mobility, particularly affecting small joints such as the wrist. Despite pharmacological treatments, many patients continue to experience persistent pain and functional limitations.
Lavender aromatherapy massage is considered a complementary therapy that may help reduce pain and improve circulation and joint flexibility through both mechanical stimulation and the therapeutic properties of lavender essential oil.
This study is designed as a randomized controlled trial to examine the effect of lavender aromatherapy massage on pain intensity and wrist joint mobility in patients diagnosed with rheumatoid arthritis. Eligible participants will be randomly assigned into two groups: an intervention group receiving lavender aromatherapy massage in addition to routine medical care, and a control group receiving routine medical care only.
Pain intensity will be assessed using a standardized pain scale, and wrist joint mobility will be measured using appropriate clinical assessment tools before and after the intervention period.
The results of this study may contribute to evidence-based practice by determining whether lavender aromatherapy massage can be recommended as a safe and effective complementary intervention for managing pain and improving joint mobility in patients with rheumatoid arthritis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ethar Haider Fadhil, PhD Candidate
- Phone Number: +9647810626779
- Email: ethar.najm2102m@conursing.uobaghdad.edu.iq
Study Locations
-
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Babil Governorate
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Hillah, Babil Governorate, Iraq, 51001
- Recruiting
- Marjan Teaching Hospital
-
Contact:
- Ether Haider, PhD Candidate
- Phone Number: +9647810626779
- Email: ethar.najm2102m@conursing.uobaghdad.edu.iq
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20 to 60 years
- Diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
- Seropositive for Rheumatoid Factor (RF)
- Stable dosage of RA medications (NSAIDs, csDMARDs, bDMARDs) for at least 3 months prior to enrollment with commitment to maintain the regimen
Exclusion Criteria:
- Acute joint inflammation or infection in the hands or upper back during screening
- Recent surgery (within 6 months) affecting hands or upper back
- Dermal lesions, open wounds, infections, or significant vascular pathology at treatment sites
- Serious comorbidities (uncontrolled diabetes, renal failure, cancer, severe cardiac/respiratory disease, coagulopathies, anticoagulant use)
- Pregnancy or breastfeeding
- Previous lavender aromatherapy massage within 6 months
- Documented hypersensitivity to lavender aromatherapy massage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lavender Aromatherapy Massage Group
Participants will receive lavender aromatherapy massage .
The massage will be applied using lavender essential oil according to the study protocol , twice weekly
|
Massage therapy using lavender essential oil applied to the wrist according to the study protocol , twice weekly.
|
|
Placebo Comparator: Inert Almond Oil (Placebo Massage)
Participants in this group will receive massage using inert almond oil without lavender essential oil according to the same duration , twice weekly and procedure as the experimental group .This serves as a placebo control to maintain participant blinding.
|
Massage using inert almond oil without lavender essential oil, applied with the same duration and procedure as the experimental group , twice weekly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline and after completion of the intervention period (e.g., 4 weeks).
|
Pain intensity will be measured using the Visual Analog Scale (VAS).
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate greater pain intensity.
|
Baseline and after completion of the intervention period (e.g., 4 weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wrist Joint Mobility
Time Frame: Baseline and after completion of the intervention period (e.g., 4 weeks).
|
Wrist joint mobility will be assessed using a goniometer.
|
Baseline and after completion of the intervention period (e.g., 4 weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serwan Jafar Bakey, Phd, University of Baghdad, College of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lavender-RA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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