Back to resultsEffect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease
Primary Purpose
Sleep Quality, Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Organic Atlas cedar wood essential oil (Cedrus Atantica)
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Quality focused on measuring sleep disturbances, Aromatherapy, sleep quality, Atlas cedar wood essential oil
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- ordan University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
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).
participants of this group received no intervention.
Outcomes
Primary Outcome Measures
Demographic and Situational Data Sheet
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 month before admission using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
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 day of hospitalization (before undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
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 five days (after undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03830554
First Posted
January 10, 2019
Last Updated
March 27, 2019
Sponsor
Rawan Alghzawi
Collaborators
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03830554
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rawan Alghzawi
Collaborators
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Coronary Heart Disease
Keywords
sleep disturbances, Aromatherapy, sleep quality, Atlas cedar wood essential oil
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
No Intervention
Arm Description
participants of this group received no intervention.
Intervention Type
Other
Intervention Name(s)
Organic Atlas cedar wood essential oil (Cedrus Atantica)
Other Intervention Name(s)
aromatherapy
Intervention Description
At first day of admission, Intervention group received an intervention kit consist of 5 small glass essential oil bottles. Each essential oil bottle contains a small cotton ball saturated with two drops of Organic Atlas cedar wood essential oil (Cedrus Atantica). Participants were asked to open the bottle, inhale the smell directly and put it opened at 20 cm beside bed during night.
Primary Outcome Measure Information:
Title
Demographic and Situational Data Sheet
Description
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.
Time Frame
at the day of admission
Title
sleep quality score during past month before admission using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
Description
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.
Time Frame
during past month before admission
Title
sleep quality score during past day of hospitalization (before undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI)
Description
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.
Time Frame
one day during hospitalization
Title
sleep quality score during past five days (after undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX
Description
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.
Time Frame
five days after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rawan algzawy
Organizational Affiliation
Dean of graduate studies at Jordan university of science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
wejdan khater
Organizational Affiliation
Dean of graduate studies at Jordan university of science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
ordan University of Science and Technology
City
Irbid
State/Province
Al-ramtha
ZIP/Postal Code
22110
Country
Jordan
12. IPD Sharing Statement
Citations:
PubMed Identifier
9628112
Citation
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Results Reference
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26344850
Citation
Martins DF, Emer AA, Batisti AP, Donatello N, Carlesso MG, Mazzardo-Martins L, Venzke D, Micke GA, Pizzolatti MG, Piovezan AP, dos Santos AR. Inhalation of Cedrus atlantica essential oil alleviates pain behavior through activation of descending pain modulation pathways in a mouse model of postoperative pain. J Ethnopharmacol. 2015 Dec 4;175:30-8. doi: 10.1016/j.jep.2015.08.048. Epub 2015 Sep 4.
Results Reference
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Khaled, S., Lourance, A.-H., & Ahmad, D. (2012). Psychometric testing of the Arabic version of the Pittsburgh Sleep Quality Index (A-PSQI) among coronary artery disease patients in Jordan. J Nat Sci Res, 2, 15-19.
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Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
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Ali, B., Al-Wabel, N. A., Shams, S., Ahamad, A., Khan, S. A., & Anwar, F. (2015). Essential oils used in aromatherapy: A systemic review. Asian Pacific Journal of Tropical Biomedicine, 5(8), 601-611.
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Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease
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