Sleep QualityNCT03830554
Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease
A study testing Organic Atlas cedar wood essential oil (Cedrus Atantica) in people with Sleep Quality and Coronary Heart Disease, run by Rawan Alghzawi at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Sleep Quality, Coronary Heart Disease
- What is being tested?
- Organic Atlas cedar wood essential oil (Cedrus Atantica)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteJordan
- Study dates
- 30 Jul 2018to 5 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
ordan University of Science and Technology
Irbid, Al-ramtha, 22110
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Quality, Coronary Heart Disease
- Being tested
- Organic Atlas cedar wood essential oil (Cedrus Atantica)
- Keywords
- sleep disturbances, Aromatherapy, sleep quality, Atlas cedar wood essential oil
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Coronary Disease, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic Atlas cedar wood essential oil (Cedrus Atantica)Other
Also called aromatherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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). Receives: Other: Organic Atlas cedar wood essential oil (Cedrus Atantica) |
| control group | No intervention | participants of this group received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the day of admission
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.
Measured: 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)
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.
Measured: one day during hospitalization
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.
Measured: five days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start30 Jul 2018
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawan Alghzawi
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor-investigator, Rawan Alghzawi, Jordan University of Science and Technology
- Investigators
- rawan algzawy, Principal investigator, Dean of graduate studies at Jordan university of science and Technologywejdan khater, Study director, Dean of graduate studies at Jordan university of science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830554
- Sponsor's protocol ID
- 15/Clinical/18
- Status last verified
- Mar 2019
- First submitted
- 10 Jan 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9628112Michal 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.
PubMed 25093413Martins 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.
PubMed 26344850Khaled, 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.
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.
PubMed 25584799Buysse 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.
PubMed 2748771Alcantara 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.
PubMed 24365609Ali, 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.
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.
PubMed 26769209King, L., Wright, B., & Reynolds, A. (2015). AROMATHERAPY.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03830554
- Acronym / sponsor ID
- 15/Clinical/18
- Conditions
- Sleep Quality, Coronary Heart Disease
- Keywords
- sleep disturbances, Aromatherapy, sleep quality, Atlas cedar wood essential oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Rawan AlghzawiUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Organic Atlas cedar wood essential oil (Cedrus Atantica)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). |
| control group | No intervention | –participants of this group received no intervention. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organic Atlas cedar wood essential oil (Cedrus Atantica)Also: aromatherapyAt 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 | intervention group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Background: PubMed 9628112Sano 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.
- Background: PubMed 25093413Michal 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.
- Background: PubMed 26344850Martins 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.
- BackgroundKhaled, 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.
- Background: PubMed 25584799Hwang 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 24365609Alcantara 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.
- BackgroundAli, 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.
- Background: PubMed 26769209Andrechuk 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.
- BackgroundKing, L., Wright, B., & Reynolds, A. (2015). AROMATHERAPY.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rawan algzawy principal investigator
Dean of graduate studies at Jordan university of science and Technology
wejdan khater study director
Dean of graduate studies at Jordan university of science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic Atlas cedar wood essential oil (Cedrus Atantica) in people with Sleep Quality and Coronary Heart Disease, run by Rawan Alghzawi at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and Situational Data Sheet (time frame: at the day of admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830554, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.