Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- State-Trait Anxiety Inventory (STAI) scores - Baseline
研究概览
简要总结
The purpose of this study is to assess the effectiveness of lavender oil as compared to standard of care (SOC) to relieve anxiety in participants undergoing a bone marrow aspirate and biopsy procedure
详细描述
Bone marrow aspiration and biopsy (BMAB) is a primarily outpatient procedure that is used to aid the diagnosis of hematological diseases. During the BMAB, local anesthesia is used however, many recipients still commonly report pain. Poorly-controlled pain has been shown to have adverse, long-lasting psychological effects and those receiving BMAB are generally significantly anxious and concerned about pain when undergoing this procedure. Previous clinical studies suggest that lavender oil aromatherapy is effective in lowering anxiety experienced by participants. It will be hypothesized that lavender oil aromatherapy will demonstrate benefit to participants suffering from anxiety during the BMAB procedure.
Participants who are undergoing BMAB and meet the inclusion criteria will be randomized to either receive aromatherapy via lavender oil before and during the duration of the BMAB, or to a SOC arm.
The primary objective of this study is to assess the efficacy of lavender oil aromatherapy as compared to placebo aromatherapy to relieve acute anxiety in participants undergoing a BMAB procedure
Secondary objectives of this study are:
To assess the efficacy of lavender oil aromatherapy as compared to placebo aromatherapy to relieve acute anxiety in participants undergoing a BMAB procedure
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- •Willingness to comply with all study interventions of lavender oil aromatherapy
- •Anxiety >3 on a 0-10 visual analog scale regarding the bone marrow biopsy/aspirate procedure
排除标准
- •Allergy to lavender oil
- •Mental incapacitation (ex. stroke, brain metastasis etc.) that would cause inability to follow directions, in the opinion of the investigators
- •Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team.
- •If a patient has a history of a psychiatric disorder, we will contact their primary cancer team to determine if their condition is controlled or uncontrolled, and if it will interfere with the study.
- •Currently pregnant
- •Recent changes in the past 2 weeks to medications prescribed for pain or anxiety
结局指标
主要结局
State-Trait Anxiety Inventory (STAI) scores - Baseline
时间窗: Within fifteen minutes pre-BMAB
The STAI measure one's conscious awareness at two extremes of anxiety affect, labeled state anxiety (A-state), and trait anxiety (A-trait), respectively. The STAI includes 20 questions about how the participant is feeling (e.g. I feel worried), each ranging from 1 to 4, with 1 indicating "not at all" and 4 indicating "very much so". Full scale ranges from 40 to 160, with higher STAI scores suggesting higher levels of anxiety. This study will use STAI at baseline and then the state anxiety inventory short form (SAI-SF) for the subsequent time points.
SAI-SF scores
时间窗: Within fifteen minutes post-BMAB
The SAI-SF utilizes six questions from the STAI state questionnaire to assess state anxiety and has shown similar results to the full form. Scores range from 6 to 24, with higher scores indicating worse anxiety. Questions relate to feeling: calm, tense, upset, relaxed, content and worried
Anxiety scores from post-procedure questionnaire
时间窗: Within fifteen minutes post-BMAB
Efficacy of LOA as compared to SOC to relieve acute anxiety in participants undergoing a BMAB procedure will be assessed by comparing anxiety scores from a post-procedure questionnaire that asks "What was the highest level of anxiety that you experienced during the procedure?" The primary analysis will compare difference scores from this anxiety score between the two groups using the Wilcoxon-Mann-Whitney test (Higher the score more is the anxiety).
次要结局
- Anxiety scores based on ESAS(Within fifteen minutes post-BMAB)
- Pre-BMAB Questionnaire(Within fifteen minutes pre-BMAB)
- Pain scores based on the BPI-SF(Within fifteen minutes post-BMAB)
- Pain scores based on ESAS(Within fifteen minutes post-BMAB)
- Post-BMAB Questionnaire(Within fifteen minutes post-BMAB)
- Percent of patients that decline the study(Within fifteen minutes pre-BMAB)
- Percent of participants completing the study(Within fifteen minutes post-BMAB)
- Pain scores based on the Brief Pain Inventory Short Form (BPI-SF)(Within fifteen minutes pre-BMAB)
- Pain scores based on Edmonton Symptom Assessment Score (ESAS)(Within fifteen minutes pre-BMAB)
- length of time of the BMAB procedure(Within fifteen minutes post-BMAB)