The effect of aromatherapy with Melissa Officinalis essene on Stress and Hemodynamic parameters of patients with acute coronary syndrome at Emergency unit
Determination of the effect of Melissa Officinalis essence on stress and hemodynamic parameters in patients with acute coronary syndrome
Design
The clinical trial has a control group, with parallel groups, three blind, randomized. The sample size is 72 patients.Computer randomization dedicated into two groups of intervention and control
Settings and conduct
The intervention is performed on two occasions in the emergency department. The aromatherapies interval is 90 minutes. Before the aromatherapy, stress level, threat perception, pain intensity, mean arterial pressure and heart rate are measured. They are re-measured 5 and 15 minutes after the end of aromatherapy. The threat perception questionnaire is used only at the beginning and end of the intervention.Blindness is performed in the researcher, the outcome assessor, the data analyst, and the participants
Participants/Inclusion and exclusion criteria
Stress score above 19 on the stress scale and Pain score of 3 and more from the visual analogue scale
Intervention groups
In the Melissa officinalis group, two drops of Melissa officinalis essence at 80% concentration and in the placebo group two drops of sunflower oil at 2% concentration with a dropper on an absorbent patch attached to the oxygen mask were given and the patient was asked to inhale it for 10 minutes. 5 minutes and again 15 minutes after the end of aromatherapy، the level of stress, pain , mean arterial blood pressure and heart rate will be measure. Completing the threat perception questionnaire is only at the beginning and end of the intervention. The aromatherapies interval is 90 minutes in emergency department. Aromatherapy will take place in the morning to evening shifts between 8:00 to 23:00.
Main outcome variables
Stress; Mean Atrial pressure; Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150919024080N14
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Melissa Officinalis essene on Stress and Hemodynamic parameters of patients with acute coronary syndrome at Emergency unit
Public title
The effect of Melissa on stress and hemodynamic parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of acute coronary syndrome by a specialist based on evidence based electrocardiogram and clinical signs and troponin index
No respiratory disease such as asthma and COPD and allergies or allergies to plants
Entering the emergency department without cardiac arrest
Vigilance and Awareness of place, time and person
No history of head trauma and seizure
No history of confirmed mental illness
No opium and alcohol addiction
No history of PTSD in during the last six months
No history of using other complementary therapies for at least one month before intervention
No disruption of sense of smell
Mean arterial blood pressure more than 90 and heart rate more than 60
Patients with chest pain severity of 3 and more based on visual analogue scale (VAS)
Age over 35 and under 65 years
Exclusion criteria:
Patients Candidate for primary PCI
Patient's unwillingness to continue participation
Unstable hemodynamic (20% change compared to time of start intervention)
Incidence of arrhythmias and allergic and respiratory problems during intervention
Transfer patients from the emergency department to the intensive care unit in less than 3 hours
Patient connection to mechanical ventilation
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria will be assigned to the two study groups using stratified randomized block design (to match the two groups according to sex and severity of pain). In this way, the first stage of the patient's sex is considered and in different sex the severity of pain in the categories 3-6.9 and 7-10 is considered as the second floor and within the patient classes as 4 or 6 blocks with The use of the computer will be randomly assigned to the two study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Melissa Officinalis essence and placebo will be poured into Barry's similar dark glass containers by Barij essence Company and the dishes will be coded by a person who has no role in the study and will be covered by a black bar. The code of the essential oil containers will remain with the research partner until the end of the analysis. The researcher, the statistical consultant, the interventionist, and study participants will be unaware of the contents of the dishes. The therapist will also use a nasal clip for 10 minutes during aromatherapy.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Iran University of Medical Sciences, Lorestan, Khorram Abad, 5 Km.
City
Khorram Abad
Province
Lorestan
Postal code
381351698
Approval date
2019-09-07, 1398/06/16
Ethics committee reference number
IR.LUMS.REC.1398.144
Health conditions studied
1
Description of health condition studied
Acute coronary syndrom
ICD-10 code
I21.4
ICD-10 code description
Non-ST elevation (NSTEMI) myocardial infarction
2
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
3
Description of health condition studied
Aromatherapy
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Mean atrial pressure and Heart rate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress score in DASS-21 questionnaire
Timepoint
Before intervention, 5 and 15 minutes after the end of aromatherapy on two occasions of aromatherapy
Method of measurement
DASS-21 Stress Questionnaire
2
Description
Mean Atrial Pressure
Timepoint
Before intervention, 5 and 15 minutes after the end of aromatherapy on two occasions of aromatherapy
Method of measurement
Cardiac Monitoring machine
3
Description
Heart rate
Timepoint
Before intervention, 5 and 15 minutes after the end of aromatherapy on two occasions of aromatherapy
Method of measurement
Cardiac Monitoring machine
4
Description
Threat perception score
Timepoint
Before and the end of intervention
Method of measurement
Threat Perception Questionnaire
Secondary outcomes
1
Description
قبل از مداخلهpain
Timepoint
Before the intervention, 5 and 15 minutes after the intervention in two aromatherapy treatments
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Melissa officinalis essence 80%, one drop, two times and 90 minutes away،For 10 minutes at a time، Inhaler with oxygen mask، Adonis Pharmaceutical Company
Category
Other
2
Description
Control group: 2% sunflower oil, two drop, two times and 90 minutes away،For 10 minutes at a time، Inhaler with oxygen mask، Adonis Pharmaceutical Company