Comparison of the effect of aromatherapy with Citrus Aurantium and foot reflexology on sleep quality and physiological index in patients with heart failure in cardiac care units
Comparison of the effect of aromatherapy with Citrus Aurantium and foot reflexology on sleep quality and physiological index in patients with heart failure in cardiac care units
Design
This is a randomized clinical trial,were randomly assigned into three groups (based on odd and even case number) of orange blossom essential oil aromatherapy, foot reflexology, and control.
Settings and conduct
in patients with heart failure hospitalized in the CCU of Ahvaz educational hospitals
Participants/Inclusion and exclusion criteria
Inclusion criteria:؛ informed consent to Participate in Research؛ Final diagnosis of heart failure in grade two and three by the cardiologist؛ With EF 20-40%؛ Age of people 40 to 65 years؛ 5Awareness of time, place, and persons and no history of known mental and psychiatric disorders.؛No allergy to essences ؛ No history of peripheral neuropathy, venous thrombosis, and foot disability, and lack of open wound on reflex points؛ Physical ability to adopt the desired body postures during the intervention (massage)؛No use of complementary medicine methods within a week.
Intervention groups
In the aromatherapy intervention group, the subjects inhaled a sterilized napkin impregnated with three drops of orange blossom essential oil (Vareth Pharmaceutical Research Complex) approved by the Medicinal Herbs Research Center of the Jundishapur Ahvaz Medical Sciences University, with three deep breaths at 10 PM in three consecutive days. In the reflexology group, the intervention was performed by the researcher on female subjects and by a male assistant on male subjects according to the Manual Reflexology Method of Fr. Josef Eugster based on the Ingham method in the bed in a private room to create an atmosphere of confidence. Reflexology was performed in three days for 30 min (15 min on each foot).
Main outcome variables
sleep quality؛ physiological parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180601039930N1
Registration date:2018-10-14, 1397/07/22
Registration timing:retrospective
Last update:2018-10-14, 1397/07/22
Update count:0
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
Elahe Qayem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 6702
Email address
qayem.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of aromatherapy with Citrus Aurantium and foot reflexology on sleep quality and physiological index in patients with heart failure in cardiac care units
Public title
Comparison of the effect of aromatherapy with Citrus Aurantium and foot reflexology on sleep quality and physiological index in patients with heart
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious Consent to Participate in Research
Final diagnosis of heart failure in grade two and three by the cardiologist
With EF 20-40%
Age of people 40 to 65 years
Knowledge of time and place and the absence of known mental and psychiatric disorders
Exclusion criteria:
having allergies to essential oils
Lack of peripheral neuropathy, venous thrombosis, organ failure in open-sided open-stenosis at the reflexion site
Physical ability to be in the desired conditions for intervention: Massage.
use of a variety of complementary medicine methods within a week
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table After obtaining written consent, the patients were randomly assigned into three groups; two intervention groups and one control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of Ahvaz University of Medical Sciences
Street address
, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-05-11, 1397/02/21
Ethics committee reference number
IR.AJUMS.REC.1397.123
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
sleep quality
Timepoint
Reflexology was performed in three days for 30 min (15 min on each foot).
Method of measurement
Pittsburgh standard sleep quality questionnaire (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1-orange blossom essential oil aromatherapy: In the aromatherapy intervention group, the subjects inhaled a sterilized napkin impregnated with three drops of orange blossom essential oil (Vareth Pharmaceutical Research Complex) approved by the Medicinal Herbs Research Center of the Jundishapur Ahvaz Medical Sciences University, with three deep breaths at 10 PM in three consecutive days
Category
Rehabilitation
2
Description
Intervention group: In the reflexology group, the intervention was performed by the researcher on female subjects and by a male assistant on male subjects according to the Manual Reflexology Method of Fr. Josef Eugster based on the Ingham method in the bed in a private room to create an atmosphere of confidence. Reflexology was performed in three days for 30 min (15 min on each foot).
Category
Rehabilitation
3
Description
Control group:The control group received only the routine care of the ward in similar conditions with no intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
in the CCU of Ahvaz educational hospitals
Full name of responsible person
Habib hey bor
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
, Jundishapur University of Medical Sciences, Ahvaz, Iran
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 33362414
Email
elahi-n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amineh qayem
Position
MSc of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
Amineh.qayem2016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amineh qayem
Position
MSc of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
Amineh.qayem2016@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
A portion of the data is disseminated after being unidentified.
When the data will become available and for how long
Get started since 2018
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
If referenced to the results of the research can be used.
From where data/document is obtainable
Corresponding Author ٍEmail
What processes are involved for a request to access data/document
After a week, agreement will be sent to your emails.