The effect of lavender inhalation on the anxiety, stress and hemodynamic parameters (RR, BP, PR) in removal of sheath in patients after coronary angiography
The main objectives of this study is evaluating the effect of lavender inhalation on the anxiety, stress and hemodynamic parameters (RR, BP, PR) during sheath removal in patients after coronary angiography in selected hospital of AJA University Medical Sciences. Study design: randomized, double-blind, placebo-controlled, single-center, phase II trial. The method of this study is: Study population: patients undergoing angiographic with inclusion criteria, hospitalized in Fajr Hospital. Inclusion criteria: Age 65-18-years-old ؛ Having No history angiography ؛Sheet lasting at least 4 hours after angiography according to the physician orders ؛ No mental illness ؛ No use of sedative or anti-anxiety drugs ؛ No history of allergy to the smell of plants ؛ Tend to smell of lavender ؛ The absence of migraine or chronic headaches. Exclusion criteria: Expressed dissatisfaction with the inhalation of lavender. Sample size: 70 samples. Studied interventions: aromatherapy with lavender extract. Intervention time: four hours after angiography. Primary outcome or consequences of the study: reduce anxiety and stress during remove the sheet in patients after angiography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012226145N1
Registration date:2016-08-08, 1395/05/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-08, 1395/05/18
Registrant information
Name
Fatemeh Teymouri
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5588 0283
Email address
f.teymori@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Financial resources funded by Army University Medical Science
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender inhalation on the anxiety, stress and hemodynamic parameters (RR, BP, PR) in removal of sheath in patients after coronary angiography
Public title
Effect of aromatherapy with Lavender on anxiety and stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 65-18 years; having ability to read and write; no history of mental illness; knowing the time, place, and person; no drug abuse; first experience of angiography; sheet lasting at least 4 hours after angiography according to the physician orders; no smell dysfunction; No use of anti-anxiety or sedatives drugs, except routine; no history of allergy to the smell of plants; tend to smell of lavender; the absence of migraine or chronic headaches. Exclusion criteria: expressed dissatisfaction with the inhalation of lavender
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:
70
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
Ethics committee of Army University Medical Science
Street address
Fatemi Street. Street Etemadzadeh
City
Tehran
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.AJAUMS.REC.1394.46
Health conditions studied
1
Description of health condition studied
Anxiety and stress
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
90 minutes before and after intervention
Method of measurement
Spielberger tool
2
Description
Blood pressure
Timepoint
10 minutes before the intervention and 30 minutes after intervention
Method of measurement
In millimeters of mercury using mercury sphygmomanometer
3
Description
Breathing
Timepoint
10 minutes before the intervention and 30 minutes after intervention
Method of measurement
The number of breaths in one minute by the chronometer
4
Description
Pulse
Timepoint
10 minutes Before the intervention and 30 minutes after intervention
Method of measurement
Pulse rate per minute by the chronometer
5
Description
Stress
Timepoint
Before and 90 minutes after intervention
Method of measurement
Dass tool
Secondary outcomes
empty
Intervention groups
1
Description
Water is used as a placebo in control group
Category
Placebo
2
Description
In the intervention group 4 hours after angiography, two drops of lavender extract on a piece of cotton and poured in a cup includes 10 cc and put in a distance of 5 cm from the nose and inhale for 20 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fajer Hospital
Full name of responsible person
Mohammad Pourmirzaie
Street address
FAJR Hospital Pirozi Street Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Army University Medical Science
Full name of responsible person
Doctor Zare'ian
Street address
Street Fatemi Street Etemadzadeh
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 of Army University Medical Science
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
Army school of Nursing
Full name of responsible person
mohammad pourmirzaie
Position
Masters student
Other areas of specialty/work
Street address
ALI town HEJRAT streets
City
tehran
Postal code
Phone
00
Fax
Email
mpormirzaie@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fatemeh Teimouri
Position
Master of Nursing
Other areas of specialty/work
Street address
Army Faculty of Nursing,KAJ Street,Shariati Street, TEHRAN
City
TEHRAN
Postal code
Phone
+98 21 7750 0929
Fax
+98 77601533
Email
f.teymori@ajaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing
Full name of responsible person
Mohammad Pourmirzaie
Position
Masters student
Other areas of specialty/work
Street address
FAJR Hospital
City
TEHRAN
Postal code
Phone
+98 21 3322 8132
Fax
Email
mpormirzaie@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)