Protocol summary

Summary
The present study aimed to compare the effects of perfume sour orange and geranium plant much of global anxiety and fatigue in patients with acute heart attack is carried out. The three-group study, a randomized, double-blind study with placebo. Inclusion criteria: patients with acute heart attack age 18-60 years old; a definite diagnosis of acute heart attack by a physician, and her EC endorsing a heart attack; DNR heart; lung at admission; no history of allergic rhinitis, eczema or respiratory problems such as asthma or chronic obstructive pulmonary disease known; Lack of sense of smell and taste disorders. Lack of medical disorders or uncontrolled contagious. being aware of the time and place and people. Lack of mental illness known. with no history of head injury or seizures. along with a disturbing lack of sleep disorders such as migraine, rheumatoid arthritis, breathing problems at night. having a drug addiction. stable vital signs. having no pain at the time of interview and questionnaire. insensitivity to smell the fragrances; score of more than 20% of Anxiety Inventory (STAI) and the fatigue score between 20 -100 questionnaire MFI-20. Exclusion criteria: the patient's unwillingness to continue the study; cardiogenic shock, cardiac arrest; lung and heart attack this time intervention; a decreased level of consciousness during intervention; the risk of heart rhythm, ventricular fibrillation and cardiogenic shock during the intervention; The use of benzodiazepines, analgesics and anti-anxiety for at least ten hours before the intervention and after the intervention; The use of complementary medicine Sayrdrman for at least a week before the intervention; The incidence of allergic and respiratory dysrhythmias and problems the intervention hemodynamically unstable time intervention patient died before the completion of the study 120 participants. Anxiety and fatigue questionnaires before and after every half an hour and fifteen minutes after the questionnaire both before the intervention, anxiety and fatigue are evaluated after half an hour. Aromatherapy with sour orange and geranium can be as effective as a simple, low-cost, safe in nursing care be considered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011824080N10
Registration date: 2017-02-17, 1395/11/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-17, 1395/11/29
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
Lorestan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-07-22, 1396/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A compersion effect of Citrus Aurantium Fragrance and Cranesbill on Anxiety and Severity of Fatigue
Public title
Effect of Aromathrapy on Anxiety and Severity of Fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
age 18-60 years old; a definite diagnosis of acute heart attack by a physician, and her EC endorsing a heart attack; DNR heart; lung at admission; no history of allergic rhinitis, eczema or respiratory problems such as asthma or chronic obstructive pulmonary disease known; Lack of sense of smell and taste disorders. Lack of medical disorders or uncontrolled contagious. being aware of the time and place and people. Lack of mental illness known. with no history of head injury or seizures. along with a disturbing lack of sleep disorders such as migraine, rheumatoid arthritis, breathing problems at night. having a drug addiction. stable vital signs. having no pain at the time of interview and questionnaire. insensitivity to smell the fragrances; score of more than 20% of Anxiety Inventory (STAI) and the fatigue score between 20 -100 questionnaire MFI-20. Exclusion criteria: the patient's unwillingness to continue the study; cardiogenic shock, cardiac arrest; lung and heart attack this time intervention; a decreased level of consciousness during intervention; the risk of heart rhythm, ventricular fibrillation and cardiogenic shock during the intervention; The use of benzodiazepines, analgesics and anti-anxiety for at least ten hours before the intervention and after the intervention; The use of complementary medicine Sayrdrman for at least a week before the intervention; The incidence of allergic and respiratory dysrhythmias and problems the intervention hemodynamically unstable time intervention patient died before the completion of the study
Age
From 18 years old to 65 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan Medical Sciences and Health Services
Street address
Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology
City
Khorramabad
Postal code
987654321
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
160 .1395. LUMS.REC

Health conditions studied

1

Description of health condition studied
َAcute Myocardial Infarecthion
ICD-10 code
141
ICD-10 code description
Myocarditis in diseases classified elsewhere

Primary outcomes

1

Description
Anexity
Timepoint
Half an hour before and 15 minutes after intervention, twice a day
Method of measurement
Questionnaire using the Spielberger

2

Description
Fatigue
Timepoint
Half an hour before and half an hour after treatment, twice a day
Method of measurement
Using the questionnaire fatigue Mfi

Secondary outcomes

1

Description
Headache
Timepoint
An hour after intervention
Method of measurement
Ask the patient

Intervention groups

1

Description
Aromatherapy start in the second and third days after the attack of acute hemodynamic conditions are Bymarpaydar is and will continue to DAY fourth after admission. For those in the intervention group (n = 80) are useful, Azrayhh of sour orange and geranium will be used. Aromatherapy twice daily (hours 10-11Sbh and 6-7Sr), the two Rvzmtvaly a week for 20 minutes will be used
Category
Treatment - Drugs

2

Description
For patients in the placebo group (n = 40) of sunflower oil will be used. each time for 20 minutes is performed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rahimi martyr city of Khorramabad hospitals
Full name of responsible person
Razia Shyrzadgan, executive accountability, Nursing student, Mohammad Gholami, scientific answer, Nu
Street address
Khorramabad, teacher Street, near West Hospital
City
خرم آباد

2

Recruitment center
Name of recruitment center
Hospital Civil martyr city of Khorramabad
Full name of responsible person
Razia Shyrzadgan, executive accountability, Nursing student, Mohammad Gholami, scientific answer, Nu
Street address
Khairallah street humble
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mojgan Khademi
Street address
Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology.
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mojgan Khademi
Street address
Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology.
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
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
Lorestan University of Medical Sciences
Full name of responsible person
RaziehShirzadegan
Position
Nursing graduate student surgery
Other areas of specialty/work
Street address
Khorram Abad, Imam Square, the streets of the martyr needle, sub 4
City
Khorram Abad
Postal code
987654321
Phone
00
Fax
Email
raziehshirzad07@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
PhD, faculty member
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology
City
Khorramabad
Postal code
987654321
Phone
+98 66 3312 0140
Fax
Email
mohammad13565@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
RaziehShirzadegan
Position
Nursing Student
Other areas of specialty/work
Street address
Khorram Abad, Imam Square, Alley martyr sozani, sub 4
City
Khorram
Postal code
987654321
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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