Goal of study:The effect of combined inhaled combination of lavender, chamomile and Neroli on anxiety in patients with acute coronary syndrome. A one blinded randomized clinical trial with control group. Study population: All patients with acute coronary syndrome at their second day of hospitalization in coronary care unit of Sajjad Hospital (a general hospital affiliated to Iran University of Medical Sciences) The eligible patients will be randomly assigned to the aromatherapy, placebo and control groups using randomization .
Allocation:25 patients in each group.Aromatherapy, placebo, control groups
Both patients and interviewers were unaware of the treatment each patient had received.The medication will be given to the patients by researcher and the effect of treatments will be evaluated by another researcher independently.
Intervention:In the aroma group, two drops of the blend of lavender, roman chamomile and Neroli oils at a ratio of 6:2:0/5 will be shed on pad eyes and the patients are asked from a distance of 5 cm inhale through 10 deep breaths at 7 pm and the aroma pad will be placed under the patients pillow until the following morning.
In the placebo group, patients will be received two drops of distilled water as a placebo on pad eyes at the same time and method of the aroma group.
The control group will be received conventional nursing care.
The demographic data form and state and trait anxiety with Spielberger inventory and base vital signs data will be completed on the evening of intervention day.
Anxiety level will be measured 30 minutes after intervention, at 7:30 pm and will be assessed at 7 am in the day following intervention. Vital signs(systolic and diastolic pressure, pulse and respiration ) will be measured once 30 minutes after intervention and 3 times (each 4 hours) after the procedure, in each groups .
General information
Acronym
ACS:Acute Coronary Syndrom
IRCT registration information
IRCT registration number:IRCT2015073023419N1
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Raheleh Rahmani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6532 4031
Email address
rahmani.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation of aroma blend containing Lavender, Roman chamomile and Neroli on anxiety and vital signs of Acute Coronary Syndrome patients
Public title
The effect of Aromatherapy on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-80 years; established diagnosis of Unstable Angina and Miocardial Infarction; not having cardiomyopathy; no indication of cardio pulmonary resuscitation; no history of smelling impairments, allergic, rhinitis, eczema, herbal or essence allergic, respiratory disease such as asthma, anxioligic or mental disorders; close relatives death in recent one month; obtaining a score of more than 20 in the Speilberger State Anxiety Inventory; ability to talk and understand Persian; no need for angiography or surgery in next day after intervention; being oriented to person, place and time
Exclusion criteria:
Lack of consent ti continue study; experienced cardiac dysrhythmia, pain or dyspnea; death during the study; patients who developed allergy to aroma
Age
From 20 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization with table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Hospital, Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2015-06-18, 1394/03/28
Ethics committee reference number
IR.IUMS.REC.1394.26598
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrom
ICD-10 code
NEC 124.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
anxiety
Timepoint
30 min before intervention and 30 min after intervention and following tomorow morning at 7 am
Method of measurement
Spielberger State-Trait Anxiety
2
Description
blood pressure
Timepoint
30 min before intervention and 30 min after intervention and each 4 hours until following tomorow morning at 7 am
Method of measurement
manitor Novin 51800 saadat co.
3
Description
pulse
Timepoint
30 min before intervention and 30 min after intervention and each 4 hours until following tomorow morning at 7 am
Method of measurement
Pulse count by the researcher in a minute
4
Description
respiration
Timepoint
30 min before intervention and 30 min after intervention and following tomorow morning at 7 am
Method of measurement
Visit chest going up and down in a minute by researcher
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention droup 1:The aroma group , two drops of the blend of Lavender,Roman chamomile and Neroli oils at a ratio of 6:2:0/5 will be shed on pad eye and the patients are asked from a distance of 5cm inhale through 10 deep breaths at 7 pm and the aroma pad will be placed under the patients pillow until the following morning.
Category
Treatment - Other
2
Description
Intervention group 2: placebo group, patients will be received two drops of distilled water on eyepad and the patiens are asked from a distance of 5cm inhale through 10 deep breaths at 7 pm and the aroma pad will be placed under the patients pillow until the following morning.
Category
Placebo
3
Description
Control group : will be received conventional nursing care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Sajjad Hospital
Full name of responsible person
Raheleh Rahmani
Street address
Valieasr avenue, Shahriar, Tehran
City
Shahriar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Next to Milad Hospital, Hemmat Highway, Tehran
City
Tehran
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 of Iran 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
Iran University of Medical Sciences-School of Nursing & Midwifery
Full name of responsible person
Jale Mohammadaliha
Position
Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Rasheed yasami Alley, Valieasr Avenue, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
mohammadaliha.j@iums.ac.ir
Web page address
fnm@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences-School of Nursing & Midwifery
Full name of responsible person
Jale Mohammadaliha
Position
Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Rasheed yasami Alley, Valieasr Avenue, Tehran.
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
mohammadaliha@iums.ac.ir
Web page address
fnm@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences-School of Nursing & Midwifery
Full name of responsible person
Raheleh Rahmani
Position
Master student of Critical Care Nursing
Other areas of specialty/work
Street address
Rasheed yasami Alley, Valieasr Avenue, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 6522 6043
Fax
+98 21 8820 1978
Email
rahmani.r@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)