Effect of aromatherapy with lemon balm versus placebo (sesame oil) on anxiety of patients with heart disease hospitalized in intensive care units: a single blind randomized clinical trial
Objectives: To assess the effect of aromatherapy with lemon balm versus placebo (sesame oil) on anxiety of patients with heart disease hospitalized in intensive care units.
Design: A single blind randomized clinical trial.
Setting and conduct: The eligible patients with heart disease who will be hospitalized in intensive care units of hospitals affiliated with Shahid Beheshti University of Medical Sciences during the study period will be enrolled into the trial.
Inclusion criteria: Age of 20 to 75 years; acute coronary syndrome.
Exclusion criteria: Olfactory disorder; asthma; allergy; psychiatric disorder; unconsciousness; ventricular tachycardia; ventricular fibrillation; cardiac resuscitation at the time of admission; having angina during interview; using herbal remedies in the past week.
Intervention group: Aromatherapy with 4 drops of lemon balm placebo (sesame oil) for half an hour twice a day for 3 days.
Control group: Aromatherapy with 4 drops of sesame oil (placebo) for half an hour twice a day for 3 days.
Primary outcome: Assessing anxiety using the Spiel Berger standard questionnaire before and immediately after intervention.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709219014N188
Registration date:2017-09-26, 1396/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatherapy with lemon balm versus placebo (sesame oil) on anxiety of patients with heart disease hospitalized in intensive care units: a single blind randomized clinical trial
Public title
Effect of aromatherapy with lemon balm versus placebo (sesame oil) on anxiety of patients with heart disease hospitalized in intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 20 to 75 years; acute coronary syndrome.
Exclusion criteria: Olfactory disorder; asthma; allergy; psychiatric disorder; unconsciousness; ventricular tachycardia; ventricular fibrillation; cardiac resuscitation at the time of admission; having angina during interview; using herbal remedies in the past week.
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Postal code
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.SBMU.PHNM.1395.485
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Assessing anxiety
Timepoint
Before and immediately after intervention
Method of measurement
Using the Spiel Berger standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aromatherapy with 4 drops of lemon balm placebo (sesame oil) for half an hour twice a day for 3 days.
Category
Treatment - Drugs
2
Description
Control group: Aromatherapy with 4 drops of sesame oil (placebo) for half an hour twice a day for 3 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated with Shahid Beheshti University of Medical Sciences
Full name of responsible person
Adeleh Lotfi
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Danshjou Bul.
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 and Technology, Shahid Beheshti 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
School of Nursing and Midwifery
Full name of responsible person
Adeleh Lotfi
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Postal code
Phone
+98 21 2243 9770
Fax
Email
adelelotfi842@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Adeleh Lotfi
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Postal code
Phone
+98 21 2243 9770
Fax
Email
adelelotfi842@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)