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Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease

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ClinicalTrials.gov Identifier: NCT03830554
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Jordan University of Science and Technology
Information provided by (Responsible Party):
Rawan Alghzawi, Jordan University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Sleep Quality Coronary Heart Disease Other: Organic Atlas cedar wood essential oil (Cedrus Atantica) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease: a Randomized Controlled Trial
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Other: Organic Atlas cedar wood essential oil (Cedrus Atantica)
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.
Other Name: aromatherapy

No Intervention: control group
participants of this group received no intervention.



Primary Outcome Measures :
  1. Demographic and Situational Data Sheet [ Time Frame: 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.

  2. sleep quality score during past month before admission using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI) [ Time Frame: 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.

  3. sleep quality score during past day of hospitalization (before undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX (PSQI) [ Time Frame: 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.

  4. sleep quality score during past five days (after undergoing cardiac catheterization) using Arabic version of PITTSBURGH SLEEP QUALITY INDEX [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830554


Locations
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Jordan
ordan University of Science and Technology
Irbid, Al-ramtha, Jordan, 22110
Sponsors and Collaborators
Rawan Alghzawi
Jordan University of Science and Technology
Investigators
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Principal Investigator: rawan algzawy Dean of graduate studies at Jordan university of science and Technology
Study Director: wejdan khater Dean of graduate studies at Jordan university of science and Technology

Publications:
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.
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.
King, L., Wright, B., & Reynolds, A. (2015). AROMATHERAPY.

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Responsible Party: Rawan Alghzawi, master student at nursing faculty, Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03830554     History of Changes
Other Study ID Numbers: 15/Clinical/18
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rawan Alghzawi, Jordan University of Science and Technology:
sleep disturbances
Aromatherapy
sleep quality
Atlas cedar wood essential oil
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases