The Use of Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Toward Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Anxiety Score
研究概览
简要总结
This clinical trial will assess whether aromatherapy inhalation (especially lavender extract essential oil) can be used as a complementary therapy for anxiety and pain. In this study, outcomes will be measured using the Numeric Rating Scale (NRS) for pain score and State-Trait Anxiety Inventory (STAI) questionnaire to assess state and trait anxiety scores. The two questionnaires above will be used to determine pre-post pain and anxiety scores after exposure. This study's primary research question is "Does linalool in lavender extract essential oil aromatherapy reduce anxiety in patients with pain complaints ?". With the question above, it is hypothesized that linalool can be an anti-anxiety towards pain. The product of aromatherapy will be tested in a GC-MS assay for every substance inside and proving linalool as a key substance. To prove the effect of linalool, this study will compare diffused lavender extract essential oil aromatherapy with a placebo to determine its effect as an anxiety reliever.
详细描述
The objective in this clinical trial is to evaluate the effect of linalool in lavender extract essential oil aromatherapy as anti-anxiety treatment for pain. The linalool inside lavender extract will be proven with GC-MS assay first. Then, after linalool has been confirmed as a key substance inside the extract, the lavender extract essential oil will be mixed with water to dilute it before it is exposed to participants in the experimental group. This study will assess anxiety and pain scale using the Numeric Rating Scale (NRS) for pain score and the State-Trait Anxiety Inventory (STAI) before exposure and 15 minutes after the exposure has been done. This complementary therapy can be an innovation in addition to conventional pain therapy, with the theory that anxiety towards pain can amplify the pain, and GABA-ergic activity in the brain can help inhibit the pain.
Study design: This study is using a Randomized Controlled Trials (RCT) with pre and post test assessment. This study will be blinding the participants and care provider.
Allocation:
- Participant will be allocated using simple randomization to the experimental or placebo group
- All the participants who agreed to the informed consent will be included and randomized to the experimental or placebo group
- Then every participant will be exposed to the intervention as scheduled personally
Group/Arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant will not get any information of what substances that will be the exposure or what group they are added in Care provider will received bottle A and B without any explanation what substances inside the bottle. Then the care provider will set the diffuser and diffused the substances for 30 minutes to participants
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient that complains about pain (acute or chronic) that do not have any allergic history of lavender
- •Patient doesnt have any abnormalities / disease in olfactory/respiratory
- •Pain are classified as moderate to severe pain (higher than 4 points in NRS)
- •Patient is not in pregnant conditions
排除标准
- •Exposure are not completed for 30 minutes due to any cause
- •Consuming any pain relieving drug (such as NSAID) 1 hour before exposure or in the middle between pre and post-test period
- •Any adverse event that associated to exposure or did not associated to exposure
- •There is or appears to be an allergy to lavender aromatherapy ingredients.
结局指标
主要结局
Anxiety Score
时间窗: Before exposure and 15 minutes after exposure has done
This parameter measured using State Trait Anxiety Inventory (STAI) Questionnaire. This questionnaire can be used to assess state and trait anxiety. It is consist of 2 segment, state segment for current anxiety scale and trait segment for any consistent anxiety feeling scale. This questionnaire have score range between 20 (minimum) and 80 (maximum). It is classified as mild anxiety for 20-39 points, moderate anxiety for 40-59 points, and severe anxiety for 60-80 points. This questionnaire has been tested for its validity by McDowell in 2006 with interval value 0,88. For its reliability, it has been tested by McDowell too in 2006 with alpha for S part 0,93 and T part 0,91
次要结局
- Pain Scale(Before exposure and 15 minutes after exposure has done)
研究者
Angga Ardhan Derryawan, MD
Principal Investigator
Universitas Islam Indonesia