Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:14 AM
Study NCT ID:
NCT07456657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be blinded to group allocation and type of oil used. Due to the nature of the intervention, care providers cannot be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two parallel groups: an intervention group receiving lavender aromatherapy massage in addition to routine care, and a control group receiving routine care only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Baseline and after completion of the intervention period (e.g., 4 weeks).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Wrist Joint Mobility', 'timeFrame': 'Baseline and after completion of the intervention period (e.g., 4 weeks).', 'description': 'Wrist joint mobility will be assessed using a goniometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lavender Aromatherapy', 'Massage Therapy', 'Wrist Mobility', 'Pain', 'Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis (RA)']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effect of lavender aromatherapy massage on pain intensity and wrist joint mobility in patients with rheumatoid arthritis. Participants will be randomly assigned to receive lavender aromatherapy massage in addition to standard care or standard care alone. Pain intensity and wrist mobility will be measured before and after the intervention period. The findings of this study may provide evidence regarding the effectiveness of complementary therapies in reducing pain and improving joint function in patients with rheumatoid arthritis.', 'detailedDescription': '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.\n\nLavender 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.\n\nThis 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.\n\nPain 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 to 60 years\n* Diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria\n* Seropositive for Rheumatoid Factor (RF)\n* Stable dosage of RA medications (NSAIDs, csDMARDs, bDMARDs) for at least 3 months prior to enrollment with commitment to maintain the regimen\n\nExclusion Criteria:\n\n* Acute joint inflammation or infection in the hands or upper back during screening\n* Recent surgery (within 6 months) affecting hands or upper back\n* Dermal lesions, open wounds, infections, or significant vascular pathology at treatment sites\n* Serious comorbidities (uncontrolled diabetes, renal failure, cancer, severe cardiac/respiratory disease, coagulopathies, anticoagulant use)\n* Pregnancy or breastfeeding\n* Previous lavender aromatherapy massage within 6 months\n* Documented hypersensitivity to lavender aromatherapy massage'}, 'identificationModule': {'nctId': 'NCT07456657', 'acronym': 'LAM-RA', 'briefTitle': 'Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'The Effect of Lavender Aromatherapy Massage on Pain Intensity and Wrist Joint Mobility in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Lavender-RA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lavender Aromatherapy Massage Group', 'description': 'Participants will receive lavender aromatherapy massage . The massage will be applied using lavender essential oil according to the study protocol.', 'interventionNames': ['Other: Lavender Aromatherapy Massage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inert Almond Oil (Placebo Massage)', 'description': 'Participants in this group will receive massage using inert almond oil without lavender essential oil according to the same duration and procedure as the experimental group. This serves as a placebo control to maintain participant blinding.', 'interventionNames': ['Other: Inert Almond Oil Massage']}], 'interventions': [{'name': 'Lavender Aromatherapy Massage', 'type': 'OTHER', 'description': 'Massage therapy using lavender essential oil applied to the wrist according to the study protocol.', 'armGroupLabels': ['Lavender Aromatherapy Massage Group']}, {'name': 'Inert Almond Oil Massage', 'type': 'OTHER', 'description': 'Massage using inert almond oil without lavender essential oil, applied with the same duration and procedure as the experimental group.', 'armGroupLabels': ['Inert Almond Oil (Placebo Massage)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ethar Haider Fadhil, PhD Candidate', 'role': 'CONTACT', 'email': 'ethar.najm2102m@conursing.uobaghdad.edu.iq', 'phone': '+9647810626779'}], 'overallOfficials': [{'name': 'Serwan Jafar Bakey, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Baghdad, College of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations and institutional regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student, College of Nursing, University of Baghdad', 'investigatorFullName': 'Ethar Haider Fadhil', 'investigatorAffiliation': 'University of Baghdad'}}}}