Effect of aromatherapy with Melissa officinalis versus placebo on the sleep quality and physiological indicators in patients admitted at the cardiac care unit: a single-blind randomized clinical trial
To assess the effect of aromatherapy with Melissa officinalis versus placebo on the sleep quality and physiological indicators in patients admitted at the cardiac care unit
Design
This is a single-blind randomized clinical trial, phase II, in which 96 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients admitted at the cardiac care unit in Shahid Rajaei Hospital in Tehran City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Sleep disorder
Exclusion criteria:
History of sensitivity to Melissa officinalis,
Olfactory sense disorder,
History of respiratory allergy or asthma
Intervention groups
Intervention group:
Routine treatment as well as aromatherapy with Melissa officinalis twice a day for three consecutive days
Control group:
Routine treatment as well as aromatherapy with placebo prepared by sesame oil twice a day for three consecutive days
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatherapy with Melissa officinalis versus placebo on the sleep quality and physiological indicators in patients admitted at the cardiac care unit: a single-blind randomized clinical trial
Public title
Effect of aromatherapy with Melissa officinalis versus placebo on the sleep quality and physiological indicators in patients admitted at the cardiac care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Sleep disorder
Exclusion criteria:
History of sensitivity to Melissa officinalis,
Olfactory sense disorder,
History of respiratory allergy or asthma
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. Thus, the trial will be run as triple blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.057
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention and 24, 48 and 72 hours after the intervention
Method of measurement
Using the Verran and Snyder-Halpern Sleep Scale
2
Description
Blood pressure
Timepoint
Before the intervention and 15, 30 and 60 minutes after the intervention
Method of measurement
Using a monitoring machine
3
Description
Heart rate
Timepoint
Before the intervention and 15, 30 and 60 minutes after the intervention
Method of measurement
Using a monitoring machine
4
Description
Breathe rate
Timepoint
Before the intervention and 15, 30 and 60 minutes after the intervention
Method of measurement
Using a monitoring machine
5
Description
Arterial blood oxygen saturation
Timepoint
Before the intervention and 15, 30 and 60 minutes after the intervention
Method of measurement
Using a monitoring machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment as well as aromatherapy with Melissa officinalis for 2 hours twice a day for three consecutive days
Category
Treatment - Drugs
2
Description
Control group: Routine treatment as well as aromatherapy with placebo prepared by sesame oil for 2 hours twice a day for three consecutive days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital in Tehran City
Full name of responsible person
Adeleh Lotfi
Street address
Shahid Rajaei, Niayesh intersection, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 8820 2521
Email
Adelelotfi2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Tehran University of Medical Sciences
Full name of responsible person
Adeleh Lotfi
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
Adelelotfi2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Jamileh Mohtashami
Position
Psychiatric Nursing Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
Jmohtashmi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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