The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients?
SECONDARY OBJECTIVES:
I. Does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? II. Do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience?
OUTLINE: Patients are randomized to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease
排除标准
- •Asthma or other reactive airway disease
- •Sleep apnea
- •Planned less than two week hospitalization
- •Change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial
- •Patients who have not completed their initial steroids
- •Patients who are confused and unable to give informed consent
研究组 & 干预措施
Group II (aromatherapy and essential oils week 3)
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
干预措施: Placebo (Other)
Group II (aromatherapy and essential oils week 3)
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
干预措施: Questionnaire Administration (Other)
Group I (aromatherapy and essential oils week 1)
Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
干预措施: Aromatherapy and Essential Oils (Procedure)
Group I (aromatherapy and essential oils week 1)
Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
干预措施: Placebo (Other)
Group I (aromatherapy and essential oils week 1)
Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
干预措施: Questionnaire Administration (Other)
Group II (aromatherapy and essential oils week 3)
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
干预措施: Aromatherapy and Essential Oils (Procedure)
结局指标
主要结局
Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI)
时间窗: 1 month
Statistical analysis will be performed using a mixed effects linear regression model. This model is designed to test the effects of interest (i.e., the effect of aromatherapy relative to baseline and to placebo) while accounting for the within-subject correlation arising from the repeated measures design. A 20% positive change in PSQI score will be seen as significant.
次要结局
- Improvement of common symptoms including pain, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing graded by Edmonton Symptom Assessment Scale - revised (ESASr)(Baseline to 2 weeks)
- Rate of positive experience with aromatherapy(Up to 2 weeks)
研究者
Lisa Blackburn
Principal Investigator
Ohio State University Comprehensive Cancer Center