Clinical trial NCT03830554: Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease
Official title: Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Coronary Heart Disease
Keywords: sleep disturbances
Aromatherapy
sleep quality
Atlas cedar wood essential oil
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2019-02-05
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 96 CHD participants were approached to participate in this RCT. out of those, 22 participants reported good sleep quality (PSQI SCORE \<5), their participation finished at phase one. The rest 74 participants reported poor sleep quality (PSQI score =\>5) were randomly assigned either to intervention or control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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:

  1. Intervention group received an atlas cedar wood aromatherapy for five consecutive nights.
  2. Control group received no intervention.
  3. Sleep quality of both group participants re-assessed at second day and six day of recruitment, respectively, using PSQI.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. age of participants must be between 20-64 years old.
3. participants must have an ability to understand and communicate with the researchers.

Exclusion Criteria:

included CHD patient were excluded if they:

1. pregnant women or who has a plan for pregnancy as well as any patients who their care giver is pregnant
2. have a recent cardiac attack within 24-48 hours or had a history or risk of heart failure or cardiogenic shock were excluded.
3. 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.
4. have history of psychological disorders (i.e., depression) or psychiatric disorders (i.e., schizophrenia) were excluded
5. using prescribed sedatives drugs or other complementary therapy likes herbal remediates or even aromatherapy in recent one week were excluded
6. shift workers.

Primary outcomes:
measure: Demographic and Situational Data Sheet
timeFrame: at the day of admission
measure: sleep quality score during past month before admission using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
timeFrame: during past month before admission
measure: sleep quality score during past day of hospitalization (before undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
timeFrame: one day during hospitalization
measure: sleep quality score during past five days (after undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX
timeFrame: five days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: ordan University of Science and Technology
state: Al-ramtha
Study officials:
affiliation: Dean of graduate studies at Jordan university of science and Technology
name: rawan algzawy
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean of graduate studies at Jordan university of science and Technology
name: wejdan khater
role: STUDY_DIRECTOR
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