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

March 27, 2019 updated by: Rawan Alghzawi

Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
    • Al-ramtha
      • Irbid, Al-ramtha, Jordan, 22110
        • ordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • aromatherapy
NO_INTERVENTION: control group
participants of this group received no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the day of admission
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.
during past month before admission
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.
one day during hospitalization
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.
five days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rawan Alghzawi

Collaborators

Jordan University of Science and Technology

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 30, 2018

Primary Completion (ACTUAL)

November 5, 2018

Study Completion (ACTUAL)

November 5, 2018

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (ACTUAL)

February 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/Clinical/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Heart Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe