The Effect of Combined and Single Aromatherapy of Orange and Orange Blossom Extracts on Quality of Sleep in Patients with Acute Coronary Syndrome that Hospitalized in Cardiac Care Units of Selected Shahid Beheshti University of Medical Sciences; 2017
The comparison of the effect of combined and single aromatherapy of orange and orange blossom extracts on quality of sleep in patients with acute coronary syndrome that hospitalized in cardiac care units of selected Shahid Beheshti University of Medical Sciences; 2017
Design
The patients were randomized into 4 groups and Epworth quality of sleep scale was completed for all of them. Then, in each night, in intervention groups, 3 drops of orange blossom extract, orange extract and combined orange and orange blossom extract, administered on a cotton beside of the patient's pillow before the sleeping. The control group does not receive any intervention. The next morning, St. Mary's hospital sleep quality questionnaire (SMHSQ) completed for patients and last night quality of sleep was evaluated.
Settings and conduct
This study will be carried out at selected hospitals of Shahid Beheshti University of Medical Sciences with active CCU units.
Participants/Inclusion and exclusion criteria
The minimum of age is 30 years old
Informed consent to participate in the study
Hospitalized with the acute coronary syndrome in the cardiac care unit
Minimum duration time of hospitalization is 24 hours
The stability of vital signs
Lack of known respiratory disease such as asthma
Lack of sense of smell disorders
Lack of mental disorder
The addiction to drugs and alcohol
Use of sedative and opioid drugs
The history of eczema and allergy to herbals
No consent to participate in the study
Psychological crises such as depression, mourning and divorce
Intervention groups
Group 1: administration orange extract
Group 2: administration orange blossom extract
Group 3: administration the combined orange and orange blossom extracts
Group 4: Control
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170312033035N2
Registration date:2018-08-28, 1397/06/06
Registration timing:retrospective
Last update:2018-08-28, 1397/06/06
Update count:0
Registration date
2018-08-28, 1397/06/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 532 5448
Email address
gharaee.r@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Combined and Single Aromatherapy of Orange and Orange Blossom Extracts on Quality of Sleep in Patients with Acute Coronary Syndrome that Hospitalized in Cardiac Care Units of Selected Shahid Beheshti University of Medical Sciences; 2017
Public title
The Effect of Combined and Single Aromatherapy of Orange and Orange Blossom Extracts on Quality of Sleep in Patients with the Acute Coronary Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The minimum of age is 30 years old.
Written consent to enter the study
Hospitalization of the patient with the diagnosis of acute coronary syndrome in cardiac care unit
Passed at least 24 hours of hospitalization
The stability of vital signs (Pulse, temperature, blood pressure, respiration)
Not having known respiratory problems like asthma
Lack of olfactory disorder
Lack of mental illness
Exclusion criteria:
Drug Addiction and Alcohol
Use of sedative and opiate drugs
History of eczema and allergies to plants
Dissatisfied with participating in the study
The existence of psychological crises such as depression, mourning and divorce
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak Ave, Daneshgah Blvd
City
Tehran
Province
Tehran
Postal code
9519933449
Approval date
2018-02-04, 1396/11/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.1196
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition