The effects of inhalator aromatherapy with Citrus Aurantium L. essence versus placebo on the sleep quality in heart patients: a single blinded randomized clinical trial
Objective: The effects of aroma “Citrus aurantium” on sleep quality in heart patients.
Design:
Population: Heart patients hospitalized in coronary care units of Abu Ali Sīnā hospital in Qazvin.
The Sample Size in Intervention and Control Groups is 30 people each.
Method:
First, the Informed Consent form for research should be signed. Then, the patients will be enter in study if they have score more than five in Epworth Sleepiness Scale and be positive according to the Berlin obstructive sleep apnea in idiopathic intracranial hypertension and finally, the Hospital Sleep Questionnaire will be completed before and after intervention.
The Interventions:
The sensitivity of the test with one drop of essence of Citrus aurantium with 2.5% concentration in the Intervention group, and the sunflower oil in the control one, and if no sensitive symptoms being caused during three successive nights, three drops of essence of Citrus aurantium with ten percent concentration at night will be taken via the nose by inhalation in the intervention group, and the patients will need to take three deep breaths too. In control group, three drops of the sunflower oil via the nose along with three deep breaths will be used.
Main outcome variables:
The patients’ sleep quality according to the Hospital Sleep Questionnaire “SMHSQ” will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121415789N1
Registration date:2014-02-08, 1392/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-08, 1392/11/19
Registrant information
Name
Fariba Mohamadi hariry
Name of organization / entity
Qazvin University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 26 3661 6793
Email address
aghoudosi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of personnel: 9500000 Rails- Cost Tools: 500,000 Rails- Total Cost: 10 million Rails
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of inhalator aromatherapy with Citrus Aurantium L. essence versus placebo on the sleep quality in heart patients: a single blinded randomized clinical trial
Public title
The effects of aroma " Citrus aurantium L." on sleep quality in heart patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with the Clinical diagnosis of heart disease in intensive coronary care unit.
Having a strong natural tendency for cooperation in doing some medical research and signing the Informed Consent form for research.
Stable vital signs ((blood pressure, pulse, respiration, temperature)
Patients aged over 18 and under 65.
Patients with no medical histories of mental illness having led to a long period hospitalization and the consumption of psychiatric drugs.
No use of herbal medicines in the past two weeks.
Having no allergic histories to medicines and all herbs (Herbal Medicines or Herbal remedies)
No allergy symptoms were caused about all the medicines they had taken in the allergy tests.
Positive indicators of Epworth Questionnaire (score>5)
To have taken “Berlin questionnaire for sleep apnea” to be positive.
Exclusion Criteria:
Vital sign instability which leads to a change in drug instructions.
Dosage change and the sedative drugs deletion, if desired.
The transference of patients from the Cardiac Care Unit to the other wards.
To be discharged from the hospital –doctor’s orders or against medical advice.
To display no tendencies to cooperate on the research any longer.
Allergy symptoms are to be caused.
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: in start of sampling, two blue and red balls (Called the Control and intervention balls come into use randomly selected from each of the cardiac care units (the two wards) just for the sake of sampling, and some alterations are being made to the sampling place alternatively every week until the size of the samples has reached 30.
How to blind?
No one knows in what groups they will be placed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2013-07-15, 1392/04/24
Ethics committee reference number
د/20/7615
Health conditions studied
1
Description of health condition studied
Heart Disease
ICD-10 code
120-121-12
ICD-10 code description
Ischemic Heart Disease
Primary outcomes
1
Description
Sleep Quality
Timepoint
2 hours preintervention - 3 days post intervention
Method of measurement
St Marry's Hospital Sleep Questionnaire
Secondary outcomes
1
Description
Sensitivity to Citrus Aurantium L. essence
Timepoint
2 hours preintervention- every 3 hours during intervention and 2 hours post intervention
Method of measurement
Clinical signs and symptoms
Intervention groups
1
Description
Intervention group: Aroma "Citrus aurantium" was prepared by Research Institute of Forests and Rangelands, Tehran, and diluted with sun flower oil to 10 percent of dilution. For three consecutive nights using the inhalation, every night is poured three drops on a tissue and inhale three deep breathes by patient. SMHSQ before and after will be completed.
Category
Treatment - Other
2
Description
Control group: Pure sun flower oil, for three consecutive nights using the inhalation, every night is poured three drops on a tissue and inhale three deep breath by patient. SMHSQ before and after will be completed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Fariba Moahmadi Hariry
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd. Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Zinat jourabchi
Street address
Qazvin University of Medical science - Shahid Bahonar Blvd. Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Fariba Mohamadi Hariry
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd. Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 1333 6001
Fax
+98 21 6522 6051
Email
aseman_f_hariry@yahoo ; aghoudosi@qums.ac.ir
Web page address
www.qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Fariba Mohamadi Hariry
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd.Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 282813338034
Fax
+98 28 1223 7268
Email
aseman_f_hariry@yahoo ; aghoudosi@qums.ac.ir
Web page address
www.qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Fariba Mohamadi Hariry
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd.Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 1333 6001
Fax
+98 21 6522 6051
Email
aseman_f_hariry@yahoo;aghoudosi@qums.ac.ir
Web page address
www.qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)