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Comparative Effectiveness of Lavender and Almond oil odor aroma therapy On Anxiety and Depression Patients Admitted to the cardiac intensive care unit

Protocol summary

Summary
Objective: To determine the effect of aromatherapy on anxiety and depression in patients with Khdvs Astv cardiac ICU study design: randomized, single-blind, placebo-controlled, phase 2 clinical trial Study population: patients admitted to the cardiac intensive care unit standards Help with anxiety and depression over 7-based tools HADS, age ≥ 18 years, patients with a diagnosis of ischemic heart disease, angina and myocardial infarction, non-allergic to flowers and plants or any allergy season Exclusion criteria: Cancel the patient continued study to heart failure and grade 3 or 4, discharge, death or transfer of the patient prior to the completion of the study, creating a situation of stress new interventions: a period of two days, starting at 11 am, use 2 drops of essential oil of Lavender along collar, Filled out questionnaires assessing anxiety and DEPRESION before the intervention, an hour later, 9 hours after the intervention period: Beginning in January 1391 the first case of primary outcome: length of hospital stay in patients' levels of anxiety and depression in

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012111711498N1
Registration date: 2014-06-04, 1393/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-04, 1393/03/14
Registrant information
Name
Mohamad Nategh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3134
Email address
m.n1359@mihanmail.ir
Recruitment status
Recruitment complete
Funding source
shahed University
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Lavender and Almond oil odor aroma therapy On Anxiety and Depression Patients Admitted to the cardiac intensive care unit
Public title
Lavender Aromatherapy in the Treatment of Anxiety And Dpression
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria:Having high anxiety and depression scores of 7 tools HADS,Age over 18 years , Patients with a diagnosis of ischemic heart disease, angina and myocardial infarction,No risk of cardiogenic shock, having very poor medical condition, according to doctors at the hospital, Agree attract physicians to enter patients into the study, no pacemaker, no use of complementary therapies (herbal treatments, traditional and other therapies) in a week, no history of psychiatric disorders or being treated for anxiety and depression, lack of drug abuse, no history of asthma, eczema. Exclusion criteria included: patient withdrew from the study, grade 3 or 4 heart failure, discharge, or transfer the patient died before the completion of the study, a new stressful situations
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
shahed university
Street address
tehran-around heram emam khomani
City
tehran
Postal code
345627-367480
Approval date
2013-06-29, 1392/04/08
Ethics committee reference number
175283/41

Health conditions studied

1

Description of health condition studied
ANXEITY AND DEORESION
ICD-10 code
(F00-F99)
ICD-10 code description
Neurotic, stress-related and somatoform disorders

Primary outcomes

1

Description
Anxiety
Timepoint
Before the experiment, a time period of 2 days, 9 hours after the intervention.
Method of measurement
HADS, Hospital Anxiety and Depression questionnaire

2

Description
DEPRESSION
Timepoint
Before the experiment, a time period of 2 days, 9 hours after the intervention.
Method of measurement
HADS, Hospital Anxiety and Depression questionnaire

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before the study, an hour later, 9 hours after the study
Method of measurement
Each patient monitoring devices over

2

Description
PULSE
Timepoint
Before the study, an hour later, 9 hours after the study
Method of measurement
Each patient monitoring devices over

Intervention groups

1

Description
Groups: first test: questions HADS (half hour before intervention) starting around 11 am instill 2 drops essential oil of Lavender by interfering emitters connected to a collar on paper and asking the patient to breathe normally for pin 20 minutes , second measurement: a questionnaire for a second time (an hour later at 12 noon) measured a third time: for a third time to complete the questionnaire (at 8 pm) Continued intervention: at night before bed about 10 pm for another intervention (instill 2 drops Lavender essential oil) is applied to the patient. Fourth assessment: questionnaire for the fourth time in the morning when you wake up (Hdvdsat 7) days after the same has been repeated for patients at the end of the second day and morning of the third day measurements will be performed. Intervention in the control group will be the same except that instead of a drop of Lavender essential oil is used almond oil odorless.
Category
Treatment - Drugs

2

Description
Groups:placebo test: questions HADS (half hour before intervention) starting around 11 am instill 2 drops essential oil of Lavender by interfering emitters connected to a collar on paper and asking the patient to breathe normally for pin 20 minutes , second measurement: a questionnaire for a second time (an hour later at 12 noon) measured a third time: for a third time to complete the questionnaire (at 8 pm) Continued intervention: at night before bed about 10 pm for another intervention (instill 2 drops Lavender essential oil) is applied to the patient. Fourth assessment: questionnaire for the fourth time in the morning when you wake up (Hdvdsat 7) days after the same has been repeated for patients at the end of the second day and morning of the third day measurements will be performed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Shiraz namazi
Full name of responsible person
MOHAMD NATEGH
Street address
Zand St., Shiraz
City
SHIRAZ

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed Univer Sity
Full name of responsible person
Mohamad Reza hiedari
Street address
Tehran, iran, Freeway persian golf
City
Tehran
Grant name
124554-12
Grant code / Reference number
ت22-ن15
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed Univer Sity
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
Shahed University
Full name of responsible person
Mohammad Reza Heydari
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Asr intersection of Taleghani - School of Nursing in SHAHED
City
Tehran
Postal code
002166418590
Phone
+216 6418590
Fax
Email
HEIDARI43@YAHOO.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University's OF Baghiatollah
Full name of responsible person
ABBASE EBADI
Position
PHD NURSING
Other areas of specialty/work
Street address
،Tehran, Iran, Faculty Baghiatollah
City
Tehran
Postal code
Phone
+216 6418587
Fax
Email
EBADI432@YAHOO.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
UNIVERSITY OF SHAHED
Full name of responsible person
MOHAMAD NATEGH
Position
Master of Nursing
Other areas of specialty/work
Street address
Asr intersection of Taleghani , School of Nursing in SHAHED
City
TEHRAN
Postal code
Phone
+216 6418587
Fax
Email
NATEGH.MOHAMAD@GMAIL.COM
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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