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Evaluation the effectiveness of Lavandula aromatherapy for changing of patient's vital signs in ICU in Comparision to Midazolam

Protocol summary

Summary
A single blind clinical trial will be done in Intensive care unit . Inclusion criteria: age : between 20 – 80; Sex : Male and Female; GCS: higher than 8 and equal to 8; The Base of Vital sign is recorded when patient admitted to ICU then vital sign is measured and vital sign is recorded for one hour. Vital sign : Blood pressure , respiratory rate , pulse rate. Exclusion criteria: a history of chronic respiratory disease; history of lack smell sensation; history of respiratory allergy; GCS < 8. Patient is divided two group 32 person. Group 1: Aromatherapy; Group 2: Midazolam. The data collection will be done with the completation of questionnaire. The record of vital sign (heart rate , systolic BP , Diastolic Blood pressure , respiratory rate). Another data collection is demographic questionnaire consist of age , sex , height and weight . for doing Aromatherapy , 2 drop Essential oil 2% of Lavandula that is prepared by Danesh Bonyan E'jaz Kavir Shargh of iran(Shahrood) company, 2 drop of Essential oil of Lavandula is poured on patch and the patch is connected to inside Oxygen mask and the patient inhale for 20 minutes and in Midazolam group is injected 0.05 mg/kg intravenous . Vital sign is measured by monitor unit in 5 , 10 , 15 , 20 , 30 , 60 minutes after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081335666N1
Registration date: 2017-09-06, 1396/06/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Maryam Harati
Name of organization / entity
Islamic Azad University Shahrood Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4530
Email address
m.harati90@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Shahrood Branch
Expected recruitment start date
2017-07-27, 1396/05/05
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of Lavandula aromatherapy for changing of patient's vital signs in ICU in Comparision to Midazolam
Public title
Evaluation the effectiveness of Lavandula aromatherapy for changing of patient's vital signs in ICU in Comparision to Midazolam
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age : between 20 – 80; Sex : Male and Female; GCS: higher than 8 and equal to 8; The Base of Vital sign is recorded when patient admitted to ICU then vital sign is measured and vital sign is recorded for one hour. Vital sign : Blood pressure , respiratory rate , pulse rate. Exclusion criteria: a history of chronic respiratory disease; history of lack smell sensation; history of respiratory allergy; GCS < 8.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University Shahrood Branch
Street address
Shahrood , University Blvd , Islamic Azad University Shahrood Branch
City
Shahrood
Postal code
Approval date
2017-07-27, 1396/05/05
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1396.10

Health conditions studied

1

Description of health condition studied
changing of patient's vital signs in ICU because of Anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood Presure
Timepoint
5 min , 10 min , 15 min , 20 min , 30 min , 60 min
Method of measurement
mm Hg with Barometer

2

Description
Pulse rate
Timepoint
5 min , 10 min , 15 min , 20 min , 30 min , 60 min
Method of measurement
pulse rate in minutes

3

Description
respiratory rate
Timepoint
5 min , 10 min , 15 min , 20 min , 30 min , 60 min
Method of measurement
respiratory rate in minutes

Secondary outcomes

empty

Intervention groups

1

Description
Lavandula , 2 Drops 2% , inhalation for 20 minutes
Category
Treatment - Drugs

2

Description
Midazulam , IV , 0.05 mg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatamolanbia Hospital
Full name of responsible person
Street address
Khatamolanbia Hospital
City
Shahrood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Shahrood Branch
Full name of responsible person
Maryam Harati
Street address
Shahrood , 7th Pishva st , Shahid Moghaddas Alley , plaque 122
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Shahrood Branch
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
Islamic Azad University Shahrood Branch
Full name of responsible person
Leila Khojasteh
Position
Anesthesist / Science Committee
Other areas of specialty/work
Street address
Shahrood , Islamic Azad University Shahrood Branch
City
Shahrood
Postal code
Phone
+98 23 3239 4530
Fax
Email
drlilakhojasteh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Shahrood Branch
Full name of responsible person
Maryam Harati
Position
PhD student
Other areas of specialty/work
Street address
Shahrood, 7th Pishva St. , Shahid Moghaddas Alley , plaque 122
City
Shahrood
Postal code
Phone
+98 23 3233 3264
Fax
Email
m.harati90@iau-shahrood.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Shahrood Branch
Full name of responsible person
Maryam Harati
Position
PhD student
Other areas of specialty/work
Street address
Shahrood , 7th Pishva St , Shahid Moghaddas Alley , plaque 122 122
City
Shahrood
Postal code
Phone
+98 23 3233 3264
Fax
Email
m.harati90@iau-shahrood.ac.ir
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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