The aim of this study is to determine the effect of aromatherapy with lavender on patients’ sleep quality after coronary artery bypass surgery. This study is a clinical trial. The sample includes all male and female patients undergoing coronary artery bypass graft in Kowsar Hospital of the Semnan University of Medical Sciences. The main criterion for inclusion is adequate vigilance on the first day after coronary artery bypass graft surgery. The most important exclusion criterion is the patient's loss of consciousness. The sample size is estimated 30 people for each group and a total of 60 people. In order to carry out the research,the sleep quality of the patients will be measured by using hospital sleep quality questionnaire in the morning after surgery. At second night at 9pm, Lavender in the intervention group and the placebo in control group (distilled water) will be dropped on a cotton ball at a rate of 2 drops and will be kept in front of the patients’ noses and they will be asked to breathe 10 times deeply and in the following, cotton ball will be attached to the patients’ clothes by using a pin and will be attached to his collar until 8 am. This process will be done for both groups of patients for 3 days. Then the difference between the initial sleep score and calculated sleep score will be calculated after the intervention in both groups. Finally, the difference between the scores of the two groups will be compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060811399N6
Registration date:2017-06-12, 1396/03/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-12, 1396/03/22
Registrant information
Name
Abbasali Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1082
Email address
ebrahimian.aa@gmail.com
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aromatherapy with Lavender on sleep quality patients
Public title
The Effect of aromatherapy with Lavender on sleep quality among patients undergoing Coronary Artery Bypass Graft in Semnan Kowsar Hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patients' willingness to participate in the study; Undergoing non-emergency open heart surgery for the first time; Aged between 30 and 75 years old; Stable hemodynamic condition such as systolic blood pressure higher than 90 mmHg; lack of life threatening dysrhythmia and a heart rate between 60 and 100 bpm; Not drug and alcohol addicted; lack of confirmed mental illness; No history of known allergies to lavender or seasonal allergy; lack of olfactory disorders; Lack of respiratory disorders such as asthma; Being conscious and oriented to time; Place and person and having the ability to complete hearing and speech. Exclusion criteria: Taking the sedative in addition to routine treatments; life threatening dysrhythmias or any emergency conditions requiring immediate intervention; loss of the patient’s consciousness; The patient’s willingness to quit from the study; allergy to lavender or any allergic reaction during the study.
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Barij Essence company lavender essential oil will be used in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Semnan University Of Medical sience
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SEMUMS.REC.1396.14
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
Patients sleep quality after coronary artery bypass graft
Timepoint
Daily, during 4 days
Method of measurement
Hospital sleep quality questionnaire
Secondary outcomes
1
Description
Sleep quality after water inhalation
Timepoint
Daily, during 4 days
Method of measurement
Hospital sleep quality questionnaire
Intervention groups
1
Description
In the intervention group, Lavender will be dropped on a cotton ball at a rate of 2 drops and Will be kept in front of the patient's nose and patients will be asked to breathe 10 time deeply and in the following, cotton ball will be attached to the patient's clothes by using a pin and will be attached to his collar until 8 am, Then it will be separated from the patient's clothes and will be discarded. This process will be done for patients for 3 days. After each intervention, the previous night sleep quality of the patient will be assessed by using Hospital Sleep Quality Questionnaire.
Category
Treatment - Other
2
Description
In the control group, distilled water will be dropped on a cotton ball at a rate of 2 drops and will be kept in front of the patient's nose and he will be asked to take 10 deep breaths and in the following, cotton ball will be attached to the patient's clothes by using a pin and will be attached to his collar until 8 am, Then it will be separated from the patient's clothes and will be discarded. This process will be done for patient for 3 days. After each intervention, the previous night sleep quality of the patient will be assessed by using Hospital Sleep Quality Questionnaire.