A Placebo-controlled Clinical Trial Investigating the Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Completion of PT/OT session
研究概览
简要总结
Use of inhaled essential oils to reduce the symptoms of pain or nausea, enabling a patient to have increase participation with PT or OT, thereby minimizing hospitalization-related risks and potentially reducing the length of stay in the hospital.
详细描述
The study intervention consists of 3 essential oils: lavender, mandarin and peppermint administered on an inhalation patch affixed in the chest region of the participant gown. The inhalation patch consists of hydrogel cast onto polyester film, supported by non-woven polyester fabric, covered with a polyethylene film. The proprietary foil-backed lamination on the patch is used to provide an occlusive barrier that prevents any essential oil from being absorbed through the skin. The placebo will consist of a comparable sized felt patch with adhesive backing with no essential oil applied.
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
Subjects will be assigned to an arm based upon the symptoms they are experiencing prior to their therapy session. If a patient reports nausea symptom, they will be assigned to the peppermint fragrance or a placebo. The randomization will be conducted in a 1:2 ratio, one placebo to two experimental. If a patient reports pain symptom, they will be assigned to the lavender or mandarin fragrance or placebo. The randomization will be conducted in a 1:2 ratio, one placebo to two experimental. The experimental group will then be randomized to a 1:1 ratio between lavender and mandarin. For those that refuse the aromatherapy patch will be asked to serve as a control and receive usual care with no patch.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients of acute care setting at University Health hospital
- •Provision of a signed and dated informed consent form
- •English or Spanish speaking
- •Male or Female, aged 18 years and older
- •Willing to comply with all study procedures
排除标准
- •Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion
- •Cognitive impairment
- •Unable to communicate
- •Admitted to the closed access unit or to psychiatry
- •Allergic to lavender, mandarin or peppermint oil
- •Diseases that cause olfactory disorders such as: COVID-19, benign growths or polyps, congestion from a cold, sinus infection or allergy flare-up
- •Drugs that may cause loss of the ability to smell e.g., intranasal zinc products, decongestant nose sprays and certain oral drugs such as nifedipine and phenothiazines
- •Pregnant women (self-reported)
研究组 & 干预措施
Standard of Care Group
Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session that decline the option to use an aromatherapy patch.
Pain Symptoms Arm
Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session.
干预措施: Mandarin Oil (Drug)
Placebo Group
Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session.
干预措施: Placebo (Other)
Pain Symptoms Arm
Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session.
干预措施: Lavender Oil (Drug)
Nausea Symptom Arm
Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session.
干预措施: Peppermint oil (Drug)
结局指标
主要结局
Completion of PT/OT session
时间窗: 30 minutes
The number of subjects who successfully completed physical or occupational therapy session
次要结局
- Change in Pain/Nausea Scale(Baseline to post therapy follow-up (30 minutes))