Clinical trial of study the effect of aromatherapy with Lavandula oil on pain, anxiety and hemodynamic parameters of patients after coronary artery bypass grafting surgery
Aim: determine the effect of aromatherapy with Lavandula oil on pain, anxiety and hemodynamic parameters of patients after coronary artery bypass grafting surgery
Study design: randomized, double-blind, placebo-controlled, one center
Inclusion criteria: without history of drugs affecting on neurological system; without smell disorders; without history of pulmonary diseases, hepatitis, diabetes, chronic headaches and thyroid diseases; without history of drugs abuse; orientation; without history of sensitivity to plants, especially Lavandula; without history of aromatherapy; duration of intubation in the range of 6 to 8 hours; not to use analgesic and antianxiety during 3 hours before starting of the study; having a systolic blood pressure 95 mm Hg and upper than.
Exclusion criteria: any sudden onset of severe changes in vital signs and droplet the systolic blood pressure lower than 95 mm Hg at each stage of the research.
Sample size: 98 cases
Study population: patients after coronary artery bypass grafting surgery admitted in cardiac surgery ward.
Intervention: in the intervention group 5 drops of Lavandula oil 100 % and in the placebo group 5 drops of distilled water will rub on the upper lips of patient and would be inhaled in 30 minutes by the patient. Pain intensity by using Visual Analoge Scale, the anxiety level by using part of anxiety of the hospital anxiety and depression scale and hemodynamic parameters will be measured before and after each intervention.
Time: from the early day of admitted patients in cardiac surgery ward for three consecutive days.
The primary outcome: relief of pain, anxiety and hemodynamic parameters changes after coronary artery bypass grafting surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102119617N1
Registration date:2014-12-17, 1393/09/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-17, 1393/09/26
Registrant information
Name
Ezzat Paryad
Name of organization / entity
Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
e_paryad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of study the effect of aromatherapy with Lavandula oil on pain, anxiety and hemodynamic parameters of patients after coronary artery bypass grafting surgery
Public title
The effect of aromatherapy with Lavandula oil on pain, anxiety and hemodynamic parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: admitted for coronary artery bypass surgery in cardiac surgery ward at Dr. Heshmat Educational and Medical Center in Rasht; patients over 18 years old; without history of drugs affecting on neurological system based on documents; without smell and visual disorders based on commenting of patient; without history of pulmonary diseases, hepatitis, diabetes, chronic headaches, migraines and psychological disorder; without history thyroid diseases (based on documents); without history of cardiac surgery; tendency to collaboration; without history of drugs abuse, smoking and alcohol (based on documents); orientation; without history of allergies, contact dermatitis and sensitivity to plants, especially Lavandula and cosmetic fragrances; without acute diseases; without history of aromatherapy based on documents; bedridden in Intensive Care Unit under 72 hours; duration of intubation in the range of 6 to 8 hours in the Intensive Care Unit based on documents; not to use analgesic, antianxiety drugs, sedative and narcotics during 3 hours before starting of the study and having a systolic blood pressure of 95 mm Hg and upper than.
Exclusion criteria: any sudden onset of severe changes in vital signs; onset of respiratory allergy signs and having a systolic blood pressure lower than 95 mm Hg at each stage of the research.
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
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
The ethics committee of assistance of research of Guilan University of Medical Sciences
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue
City
Rasht
Postal code
41469-39841
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
2930382805
Health conditions studied
1
Description of health condition studied
Lavender oil aromatherapy associated with pain, anxiety and hemodynamic parameters in patients after coronary artery bypass grafting surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention and half hour after the intervention every 24 hours for three consecutive days
Method of measurement
Visual Analoge Scale
2
Description
Anxiety
Timepoint
Before the intervention and half hour after the intervention every 24 hours for three consecutive days
Method of measurement
Section of anxiety of the Hospital Anxiety and Depression Scale (HADS)
3
Description
Diastolic and systolic blood pressure
Timepoint
Before the intervention and half hour after the intervention every 24 hours for three consecutive days
Method of measurement
By using a mercury sphygmomanometer based on mmHg
4
Description
Pulse
Timepoint
Before the intervention and half hour after the intervention every 24 hours for three consecutive days
Method of measurement
Based on the number of pulses in a minute
5
Description
Respiration
Timepoint
Before the intervention and half hour after the intervention every 24 hours for three consecutive days
Method of measurement
Based on the number of breaths in a minute
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group 5 drops of Lavandula oil 100% will rub on the upper lips of patient (the distance between the nose and lips) and would be inhaled in 30 minutes by the patient. Intervention will be done every 24 hours for three consecutive days after discharge from the Intensive Care Unit.
Category
Other
2
Description
In the placebo group 5 drops of distilled water will rub on the upper lips of patient (the distance between the nose and lips) and would be inhaled in 30 minutes by the patient. Intervention will be done every 24 hours for three consecutive days after discharge from the Intensive Care Unit.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Educational and Medical Center Hospital
Full name of responsible person
Ezzat Paryad
Street address
Dr. Heshmat Educational and Medical Center Hospital, 15 Khordad Avenue, next to the Management and Planning Organization of Guilan
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
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
Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery Faculty
Full name of responsible person
Ezzat Paryad
Position
M.Sc, Faculty member of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue
City
Rasht
Postal code
41469-39841
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
e_paryad@gums.ac.ir; samaneh.ebrahimi8@gmail.com
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery Faculty
Full name of responsible person
Ezzat Paryad
Position
M.Sc
Other areas of specialty/work
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue
City
Rasht
Postal code
41469-39841
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
e_paryad@gums.ac.ir; samaneh.ebrahimi8@gmail.com
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)