Determination of the effect of Aromatherapy with lavender extract on sleep quality of patients candidate for Angiography admitted to the coronary care unit of Ali Ebn Abitaleb Hospital in Rafsanjan
Design
randomized control trial with two control and intervention group
Settings and conduct
The research population of this study is all of the patients candidate for angiography admitted to the coronary care unit . Samples are selected by available method and then categorized randomly in each of the two groups.
Participants/Inclusion and exclusion criteria
inclusion criteria:
40-60 years old;
confirmation of acute coronary syndrome by cardiologist;
willingness of patient;
absence of confirmed mental disorder;
absence of history of asthma;
Not having a history of allergy to plants or any seasonal; allergies
absence of olfactory disorder;
absence of severe pain causing sleep disorder;
Their sleep quality score is at least 22;
At least 24 hours after admission to the CCU;
No entry criteria :
absence of cooperation or patient satisfaction;
No mechanical ventilation;
Lack of life-threatening complications;
Intervention groups
Then, patients complete the St. Mary's Sleep Quality Questionnaire. In the intervention group, impregnated cotton napkin with 15 drops of lavender essential oil made by Barij Essence Company and pinned it to the pillow of the patient and wound up in the morning after waking up.In the control group, we put cotton napkin into 15 drops of water and put it in the pillow of the patient. The next morning, the questionnaires were again filled up by the patients and the data were collected.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180919041067N1
Registration date:2019-04-07, 1398/01/18
Registration timing:retrospective
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
najmeh Mohammadrafie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3426 9486
Email address
mohammadrafien@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aromatherapy with lavender extract on sleep quality in hospitalized patient candidate for angiography
Public title
Investigating the effect of aromatherapy with lavender extract on sleep quality in hospitalized patient candidate for angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 40 to 60 years
Acute coronary syndrome confirmed by cardiologist
willingness to participate in the study
no history of mental disorders
no history of asthma
no history of allergy to plants or any seasonal allergy
no history of olfactory disorders
lack of severe pain that causes sleep disturbance
sleep quality score of at least 22
a minimum of 24 hours of admission to the cardiac care unit
Exclusion criteria:
Patient dissatisfaction
no need for mechanical ventilation
life-threatening complications such as Cardiopulmonary resuscitation
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected by convenience method and then categorized randomly into each of the two groups. In this method, the first samples are randomly In this method, the first samples are randomly assigned to one of the groups, and for subsequent samples, the number of samples in each of the groups is considered, and the sample is assigned to a group that is less.assigned to one of the groups and for subsequent samples the number of samples in each group is considered and the sample belongs to a group that is less.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are randomly assigned to the intervention and control group and do not have any knowledge of the presence of any of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd (Central Office of Rafsanjan University of Medical Sciences)
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-04-20, 1397/01/31
Ethics committee reference number
IR.RUMS.REC.1397.025
Health conditions studied
1
Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
2
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Patients' sleep quality score
Timepoint
Scoring the sleep quality questionnaire in two consecutive nights before intervention and after intervention
Method of measurement
St. Mary's Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The night before angiography, we impregnate cotton napkin with 15 drops of lavender 20 % and pin it to the pillow of the patient and take it in the morning after waking up.
Category
Other
2
Description
Control group: The night before angiography, we impregnate cotton napkin with 15 drops of water and pin it to the pillow of the patient and take it in the morning after waking up.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliebn Abitaleb hospital-Moffateh Blvd-rafsanjan
Full name of responsible person
Ahmadraza Sayadi
Street address
Aliebn Abitaleb hospital-Moffateh Blvd-rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
aliebn@rums.ac.ir
Web page address
https://rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmadraza Sayadi
Street address
Ali_ebn Abitaleb hospital_Moffateh Blvd_rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
info@rums.ac.ir
Web page address
https://rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Sayadi
Position
Assistant Professor, Faculty of Nursing and Midwifery, Rafsanjan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty/nursing avenue (coastal) Motahari Ave Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
parastari@rums.ac.ir
Web page address
https://nm.rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmadraza Sayadi
Position
Associate Professor of the Faculty of Nursing, Midwifery and Allied Medical Sciences of Rafsanjan
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Rafsanjan Motahari Ave nursing avenue (coastal) nursing and midwifery faculty
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+94 3434255900
Email
Sayadiahmad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Najmeh Mohammadrafie
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 17- Alley # 1, Shariati St.,Rafsanjan,
City
Rafsanjan
Province
Kermanshah
Postal code
7715714557
Phone
+98 34 3426 9486
Email
Mohammadrafien@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available