Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Demographic and Situational Data Sheet
研究概览
简要总结
Sleep-wake disturbances were found to be a common problem among patients with CHD either earlier during hospitalization or/ and after discharge Although there is an evidence that sleep-wake disturbanes occur in high rate among patients with CHD little was found about assessment and management of this problem. This randomized controlled study will assess sleep quality of stable CHD patients who were admitted for undergoing coronary angiography electively. Then it will test the hypothesis that atlas cedar wood essential oil aromatherapy have a positive effect on sleep quality of CHD patients.
详细描述
The primary aim is testing the effect of Atlas cedar wood essential oil aromatherapy on sleep quality of patients after CHD.
The secondary aim is estimating the prevalence of sleep-wake disturbances (difficulty falling asleep, staying asleep, inadequate sleep duration, dissatisfaction with a sleep and excessive daytime sleepiness) among recruited CHD patients.
- data were collected by two phase:
- phase one: sleep quality of recruited CHD patients, who were admitted for undergoing coronary angiography electively, were assessed using Pittsburg Sleep Quality Index (PSQI). CHD participants who were reported poor sleep quality (=>5) in PSQI score will randomly allocated by toss either to intervention or control group.
- Phase two:
- Intervention group received an atlas cedar wood aromatherapy for five consecutive nights.
- Control group received no intervention.
- Sleep quality of both group participants re-assessed at second day and six day of recruitment, respectively, using PSQI.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable CHD patients with history of myocardial infarction, stable angina, unstable angina or acute coronary syndrome who were admitted for elective coronary angiograph (cardiac catheterization) during the study period.
- •age of participants must be between 20-64 years old.
- •participants must have an ability to understand and communicate with the researchers.
排除标准
- •included CHD patient were excluded if they:
- •pregnant women or who has a plan for pregnancy as well as any patients who their care giver is pregnant
- •have a recent cardiac attack within 24-48 hours or had a history or risk of heart failure or cardiogenic shock were excluded.
- •have problems in smell sensations , history of breathing difficulties and disorders such as asthma, sleep apnea or allergies to plants and flowers parts were excluded, too.
- •have history of psychological disorders (i.e., depression) or psychiatric disorders (i.e., schizophrenia) were excluded
- •using prescribed sedatives drugs or other complementary therapy likes herbal remediates or even aromatherapy in recent one week were excluded
- •shift workers.
研究组 & 干预措施
intervention group
product name: organic Atlas cedar wood essential oil (Cedrus Atlantica): the intervention group smell 2 drops of organic Atlas cedar wood essential oil (applied on cotton ball) for a period of five consecutive nights (at least 8 hours each night).
干预措施: Organic Atlas cedar wood essential oil (Cedrus Atantica) (Other)
control group
participants of this group received no intervention.
结局指标
主要结局
Demographic and Situational Data Sheet
时间窗: at the day of admission
The participants were asked to fill a demographic and situational data sheet that is bulit by the researches based on the inclusion and exclusion criteria of the study. this sheet assess participants' age, gender, marital status, educational level, occupation and bed time habits. Also it have a disease related questions, that consists of time of diagnosis of CHD, presence of other chronic disease (physiological or psychological disease), previous complaint of sleep problem, medication history rather than used for CHD treatments, using of complementary therapy with justification.Through this data, female participants were asked if they are in menopausal period, pregnant or have a plan of pregnancy during next month.
sleep quality score during past day of hospitalization (before undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
时间窗: one day during hospitalization
sleep quality of participants was assessed for the second time after sleeping one night in hospital using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (one day used instead of month words). Arabic version of PITTSBURGH SLEEP QUALITY INDEX is a valid and reliable version of original English version that is a self-rated questionnaire. The instrument consists of 24 questions (19 self-rated questions and the rest 5 questions are measured objective sleep quality from bed partner. Self- rated question are only used in the scoring and they are combined to form seven component score. Each component has a score range from 0 point (no difficulty) to 3 point (extreme difficulty). Global PSQI score results from summation of seven component scores. It have a range from 0 point (no difficulty in all area) to 21 points (severe difficulties in all area). Global PSQI score \>=5 indicate a poor sleep quality where total score \<5 indicate a good sleep quality.
sleep quality score during past month before admission using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
时间窗: during past month before admission
sleep quality (during past month) of participants was assessed at the day of each patient admission. Arabic version of PITTSBURGH SLEEP QUALITY INDEX is a valid and reliable version of original English version that is a self-rated questionnaire used for measuring sleep quality for duration of one month interval. The instrument consists of 24 questions (19 self-rated questions and 5 questions measures objective sleep quality from bed partner. Self- rated question are combined to form seven component score. Each component has a score range from 0 point (no difficulty) to 3 point (extreme difficulty). Global PSQI score results from summation of seven component scores. It have a range from 0 point (no difficulty in all area) to 21 points (severe difficulties in all area). Global PSQI score \>=5 indicate a poor sleep quality where a total score \<5 indicate a good sleep quality.
sleep quality score during past five days (after undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX
时间窗: five days after admission
sleep quality of participants was assessed for the third time after five days from admission using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (five days was used instead of month words in original tool). Arabic version of PITTSBURGH SLEEP QUALITY INDEX is a valid and reliable version of original English version that is a self-rated questionnaire. The instrument consists of 24 questions (19 self-rated questions and the rest 5 questions are measured objective sleep quality from bed partner. Self- rated question are only used in the scoring and they are combined to form seven component score. Each component has a score range from 0 point (no difficulty) to 3 point (extreme difficulty). Global PSQI score results from summation of seven component scores. It have a range from 0 point (no difficulty in all area) to 21 points (severe difficulties in all area). Global PSQI score \>=5 indicate a poor sleep quality where total score \<5 indicate a good sleep quality.
次要结局
未报告次要终点
研究者
Rawan Alghzawi
master student at nursing faculty
Jordan University of Science and Technology