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

NCT ID: NCT03830554

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2018-11-05

Brief Summary

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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

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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.

Conditions

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Sleep Quality Coronary Heart Disease

Keywords

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sleep disturbances Aromatherapy sleep quality Atlas cedar wood essential oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Organic Atlas cedar wood essential oil (Cedrus Atantica)

Intervention Type OTHER

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.

control group

participants of this group received no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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aromatherapy

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role collaborator

Rawan Alghzawi

OTHER

Sponsor Role lead

Responsible Party

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Rawan Alghzawi

master student at nursing faculty

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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rawan algzawy

Role: PRINCIPAL_INVESTIGATOR

Dean of graduate studies at Jordan university of science and Technology

wejdan khater

Role: STUDY_DIRECTOR

Dean of graduate studies at Jordan university of science and Technology

Locations

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ordan University of Science and Technology

Irbid, Al-ramtha, Jordan

Site Status

Countries

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Jordan

References

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Sano A, Sei H, Seno H, Morita Y, Moritoki H. Influence of cedar essence on spontaneous activity and sleep of rats and human daytime nap. Psychiatry Clin Neurosci. 1998 Apr;52(2):133-5. doi: 10.1111/j.1440-1819.1998.tb00991.x.

Reference Type BACKGROUND
PMID: 9628112 (View on PubMed)

Michal M, Wiltink J, Kirschner Y, Schneider A, Wild PS, Munzel T, Blettner M, Schulz A, Lackner K, Pfeiffer N, Blankenberg S, Tschan R, Tuin I, Beutel ME. Complaints of sleep disturbances are associated with cardiovascular disease: results from the Gutenberg Health Study. PLoS One. 2014 Aug 5;9(8):e104324. doi: 10.1371/journal.pone.0104324. eCollection 2014.

Reference Type BACKGROUND
PMID: 25093413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26344850 (View on PubMed)

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.

Reference Type BACKGROUND

Hwang E, Shin S. The effects of aromatherapy on sleep improvement: a systematic literature review and meta-analysis. J Altern Complement Med. 2015 Feb;21(2):61-8. doi: 10.1089/acm.2014.0113. Epub 2015 Jan 13.

Reference Type BACKGROUND
PMID: 25584799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

Alcantara C, Peacock J, Davidson KW, Hiti D, Edmondson D. The association of short sleep after acute coronary syndrome with recurrent cardiac events and mortality. Int J Cardiol. 2014 Feb 1;171(2):e11-2. doi: 10.1016/j.ijcard.2013.11.135. Epub 2013 Dec 7. No abstract available.

Reference Type BACKGROUND
PMID: 24365609 (View on PubMed)

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.

Reference Type BACKGROUND

Andrechuk CR, Ceolim MF. Sleep quality and adverse outcomes for patients with acute myocardial infarction. J Clin Nurs. 2016 Jan;25(1-2):223-30. doi: 10.1111/jocn.13051.

Reference Type BACKGROUND
PMID: 26769209 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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15/Clinical/18

Identifier Type: -

Identifier Source: org_study_id