The Effect of Lavender Aromatherapy Massage on Pain Intensity and Wrist Joint Mobility in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to group allocation and type of oil used. Due to the nature of the intervention, care providers cannot be blinded.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Lavender Aromatherapy Massage (Other)
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.
干预措施: Inert Almond Oil Massage (Other)
结局指标
主要结局
Pain Intensity
时间窗: 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.
次要结局
- Wrist Joint Mobility(Baseline and after completion of the intervention period (e.g., 4 weeks).)
研究者
Ethar Haider Fadhil
PhD Student, College of Nursing, University of Baghdad
University of Baghdad