NCT07456657

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Feb 2027

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 2, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

Lavender AromatherapyMassage TherapyWrist MobilityPainRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    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 Outcomes (1)

  • Wrist Joint Mobility

    Baseline and after completion of the intervention period (e.g., 4 weeks).

Study Arms (2)

Lavender Aromatherapy Massage Group

EXPERIMENTAL

Participants will receive lavender aromatherapy massage . The massage will be applied using lavender essential oil according to the study protocol.

Other: Lavender Aromatherapy Massage

Inert Almond Oil (Placebo Massage)

PLACEBO COMPARATOR

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.

Other: Inert Almond Oil Massage

Interventions

Massage therapy using lavender essential oil applied to the wrist according to the study protocol.

Lavender Aromatherapy Massage Group

Massage using inert almond oil without lavender essential oil, applied with the same duration and procedure as the experimental group.

Inert Almond Oil (Placebo Massage)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Serwan Jafar Bakey, Phd

    University of Baghdad, College of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethar Haider Fadhil, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to group allocation and type of oil used. Due to the nature of the intervention, care providers cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, College of Nursing, University of Baghdad

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations and institutional regulations.