The effect of massage with or without aromatic substance on the incidence of delirium in patient undergoing heart surgery in Afshar Hospital, Yazd, in 2017
Applied Research Objectives:
Considering the relatively high prevalence of delirium after cardiac surgery, as well as its negative effects on the quality of life of patients, as well as increasing the length of hospitalization and mortality of patients from the disease, the findings of this study may be able to reduce the amount of Delirium treatment after open heart surgery. In addition, given the limited nursing research in this area, this study could clarify the dimensions of the use of complementary medicine and provide a basis for further research in this area.
Design
The study consisted of three groups: one control group and two intervention groups that referred to the patients referred to Afshar Hospital in Yazd for the purpose of open heart surgery, ranging in age from 18 to 75 years, and for the first time Heart surgery. Sampling method is a random allocation.
Settings and conduct
Interventional study - Afshar Hospital in Yazd
Participants/Inclusion and exclusion criteria
Patients entering the study should undergo cardiac surgery for the first time and be between 18 and 75 years of age. Do not mention dermatological sensitivities and their negative sensitivity tests and positive olfactory tests without a history of mental illness or psychiatric use
Intervention groups
Massage with aromatic substance (In this group, 13 brown massage techniques are performed using Rose Essential Oil on the base of sweet almond oil. Then, using a neecham questionnaire, the amount of delirium is measured)
Massage without aromatic substance (In this group, 13 brown massage techniques are performed solely by sweet almond oil, then using the neecham questionnaire, the amount of delirium is measured)
Control(In this group, Delirium is measured with the neecham questionnaire without massaging.
Main outcome variables
Decreasing the amount of delirium after open heart surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180509039592N1
Registration date:2018-06-06, 1397/03/16
Registration timing:registered_while_recruiting
Last update:2018-06-06, 1397/03/16
Update count:0
Registration date
2018-06-06, 1397/03/16
Registrant information
Name
Farzaneh Askarkafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3530 0773
Email address
f_askarkafi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage with or without aromatic substance on the incidence of delirium in patient undergoing heart surgery in Afshar Hospital, Yazd, in 2017
Public title
The effect of massage with or without aromatic substance on the incidence of delirium in patient undergoing heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cardiac surgery for the first time
Age between 18 and 75 years
Patients who have a positive olfactory test
Patients who have tested negative for their sensitivity
Patients who do not mention any history of skin sensitivity
Patients who do not mention any history of mental illness or psychiatric use, with the exception of chlordiaspoxide and oxazepam
Exclusion criteria:
If the patient undergoes surgical complications, he or she will be transferred to the operating room.
If the patient does not remove the mechanical ventilation until the day after surgery (do not extube)
In the event of unwanted and unpredictable effects
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who have inclusion criteria are included in the study using available sampling method and then divided into two intervention and control groups using stratified random allocation method. The samples will be placed in two groups according to gender, age (2 ±), and type of disease. In other words, the first one randomly (using a lottery) is placed in one of the two groups of intervention or control group and the subsequent samples are allocated to each of the groups according to the matching variables and observing random conditions.
Blinding (investigator's opinion)
Single blinded
Blinding description
The therapeutic effect of the intervention has been obscured by participants
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Kerman University of Medical Sciences
Street address
Four Way Somayeh (Tahmasebabad), Beginning of Jihad Boulevard, Beginning of Ibn Sina St
City
kerman
Province
Kerman
Postal code
7619813160
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.KMU.REC.1396.2227
Health conditions studied
1
Description of health condition studied
Delirium after heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Delirium: In Delirium DSM-5, Delirium is defined as a distraction of attention and concentration, which usually has a sudden onset, accompanied by disturbance in navigation, short-term memory impairment, change in sensory perception (illusion), abnormal thinking process, and turbulent behavior.
Timepoint
Before the intervention, at the end of each day, until the patient is admitted to the ICU
Method of measurement
NEECHAM delirium measurement questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage group with aromatic substance: In this group, samples are received in addition to receiving routine care, massage with scented face and face twice a day (morning and night) until the patient is admitted to the intensive care unit. (Patients are often admitted to the heart care unit for 3 to 4 days). The first massage is the day after the heart surgery, provided that the patient is extubated. The essence of the scent is the Rose Essence. In this study, the essential oil of Rose (produced by Barij Essen, Kashan) is used in the base of sweet almond oil at a concentration of 4%. For each massage, 2 cc of scented oil is used. Prior to initiating the first massage and after massage by another trained person, the incidence and severity of delirium by using the NeeCham questionnaire at the end of each day until the patient is admitted to the intensive care unit and assessed prior to discharge from the caregiver department.
Category
Prevention
2
Description
Intervention group: Massage without aromatic substant: In this group, in addition to receiving routine care, massage with 2 cc sweet peas and almond oil for 15 minutes on the day after the procedure twice a day (morning and night) As long as they are admitted to the intensive care unit. Prior to initiating the first massage and after massage by another trained person, the incidence and severity of delirium by using the NeeCham questionnaire at the end of each day until the patient is admitted to the intensive care unit and assessed prior to discharge from the caregiver department.
Category
Prevention
3
Description
Control group: In the control group only routine care is provided in the heart care unit. In this section, if the illness affects delirium, a psychiatric consultation is requested by the surgeon of the heart and after the visit by the psychiatrist, the medication orders are administered, and the patient's family is asked to come to the patient's appointment in each shift. Connect with him. At the end of each day, until the patient is admitted to the intensive care unit, she is evaluated prior to discharge from the caregiver department
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital in Yazd
Full name of responsible person
farzaneh askarkafi
Street address
Islamic Republic Boulevard, Afshar Hospital, Yazd
City
YAZD
Province
Yazd
Postal code
8917945714
Phone
+98 35 3525 5011
Email
f_askarkafi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
At the beginning of the axis of haft bagh alavi University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
f_askarkafi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh Askarkafi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of the axis ofhaft bagh alavi, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
f_askarkafi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
farzaneh askarkafi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of the axis of haft bagh alavi, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
f_askarkafi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
farzaneh askarkafi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of the axis of haft bagh alavi, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
f_askarkafi@kmu.ac.ir
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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data can be shared after unidentifiable individuals
When the data will become available and for how long
Start the month access period after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
The data is sent through an official request and by e-mail
From where data/document is obtainable
f_askarkafi@kmu.ac.ir
What processes are involved for a request to access data/document
The data is sent through an official request and by e-mail