The effect of massage aromatherapy with lavender oil on physiological indicators and pain intensity caused by the change position of patient with cerebrovascular accident admitted to the intensive care unit
Determining the effect of massage aromatherapy with lavender oil on physiological indicators and pain intensity due to changes in the condition of patients with cerebrovascular accident.
Design
Clinical trials with control, intervention and placebo groups
Randomized by simple random method on 81 patients
Settings and conduct
setting: General intensive care unit of selected Ajah hospitals In the
groups of intervention and placebo: measurement of pain and physiological indicators before the intervention and immediately after the change of the situation
Control group: measured before and after changing the situation.
Participants/Inclusion and exclusion criteria
patients with cerebrovascular accidents confirmed by the medical examiner
Age above 65 years
without history of asthma and chronic respiratory disease
Patients without a history of allergy to lavender based on the statement of the patient or the patient's companion
with no history of olfactory disorders
Patients without a history of psoriasis
No drug addiction
Patients without tracheal intubation
Healthy skin of the hands
Being hospitalized in the intensive care unit for at least 24 hours
The patient's non-use of painkillers, narcotics and sedatives 6-8 hours before, during and after the intervention
Not having angioket in the massage place
Patients without receiving drugs that increase or decrease blood pressure such as: epinephrine, dopamine, etc.
Patients without receiving anticonvulsant drugs such as: Gabapentin
Intervention groups
In the intervention group, aromatherapy with lavender oil will be performed using lavender oil in the form of massaging both hands with exfoliation technique for 2 minutes and 30 seconds for each hand, and in the placebo group, sesame oil will be used.
No intervention is performed in the control group.
Main outcome variables
pain
physiological indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240511061733N1
Registration date:2024-07-18, 1403/04/28
Registration timing:registered_while_recruiting
Last update:2024-07-18, 1403/04/28
Update count:0
Registration date
2024-07-18, 1403/04/28
Registrant information
Name
Mahsa Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7774 8531
Email address
mahsa.karami.am@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage aromatherapy with lavender oil on physiological indicators and pain intensity caused by the change position of patient with cerebrovascular accident admitted to the intensive care unit
Public title
The effect of massage aromatherapy with lavender oil on physiological indicators and pain intensity caused by the change position
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1_ Patients with a cerebrovascular accident confirmed by a physician 2_ Age over 65 years 3_ Patients without a history of asthma and chronic respiratory disease 4_ Patients without a history of allergy to lavender based on the statement of the patient or the patient's companion 5_ Patients without a history of olfactory disorders 6_ Patients without a history of psoriasis 7_ Absence of drug addiction 8_ Patients without intubation in the trachea 9_ Healthy skin of the hands 10_ Being hospitalized in the intensive care unit for at least 24 hours 11_ Patient not using painkillers, narcotics and sedatives 6-8 hours before, while and after the intervention 12- Not having an angioket at the massage site 13- Patients without receiving drugs that increase or decrease blood pressure such as: epinephrine, dopamine, dobutamine, TNG, etc. 14- Patients without receiving anticonvulsant drugs such as: Gabapentin
Exclusion criteria:
2_The patient's sensitivity to lavender during the intervention 3_Irritation and skin damage in the hands area during the study 4_Instability and sudden changes in the patient's condition 5_The need to intubate the patient during the study
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
First, in order to determine the order of entering the samples into the study, 6 draws will be conducted, and based on the order of entering the samples, they will be placed in test group 1, 2 and control. Then it will continue in the same way until the end of the sampling. It should be noted that the samples of the groups will not be selected from the same hospital at the same time.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Army Medical Sciences University
Street address
Fatemi Ave, Etemadzadeh Ave
City
Tehran
Province
Tehran
Postal code
1411718546
Approval date
2024-05-08, 1403/02/19
Ethics committee reference number
IR.AJAUMS.REC.1403.001
Health conditions studied
1
Description of health condition studied
Physiological indicators and pain caused by changes in the condition of patients with cerebrovascular accidents
ICD-10 code
I69.4
ICD-10 code description
_Sequelae of stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Pain score in Critical care Pain Observation Tool
Timepoint
Before the intervention and immediately after the change of the patient's condition for 3 consecutive days
Method of measurement
Critical care Pain Observation Tool
2
Description
Systolic Blood Pressure
Timepoint
Before the intervention and immediately after the change of the patient's condition for 3 consecutive days
Method of measurement
The monitor is available in the manufacturing department of Sa Iran company
3
Description
Diastolic Blood Pressure
Timepoint
Before the intervention and immediately after the change of the patient's condition for 3 consecutive days
Method of measurement
The monitor is available in the manufacturing department of Sa Iran company
4
Description
Respiratory Rate
Timepoint
Before the intervention and immediately after the change of the patient's condition for 3 consecutive days
Method of measurement
The monitor is available in the manufacturing department of Sa Iran company
5
Description
Pals Rate
Timepoint
Before the intervention and immediately after the change of the patient's condition for 3 consecutive days
Method of measurement
The monitor is available in the manufacturing department of Sa Iran company
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: Aromatherapy with lavender oil is an intervention that aims to reduce pain and improve physiological indicators in the present study. This intervention will be performed in a group of patients using 5 to 10 ml of Noshad lavender oil manufactured by Ganjineh Ezra Naatab company, which has a health license, in the form of massaging both hands with the exfoliation technique for 2 minutes and 30 seconds for each hand. Pain and physiological indicators are measured and recorded before the intervention and immediately after the change of position.
Category
Treatment - Other
2
Description
The second Intervention group: In this group, using 5 to 10 ml of Nowshad Sesame Oil, manufactured by Ganjineh Ezraat Nature Company, which has a health license, both hands will be massaged with the exfoliation technique for 2 minutes and 30 seconds for each hand. Pain and physiological indicators are measured and recorded before the intervention and immediately after the change of position.
Category
Placebo
3
Description
Control group: In this group, there is no intervention and only pain and physiological indicators are measured and recorded before and after the change of the patient's condition.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Mahsa Karami
Street address
Basij HWY, Hejrat Ave
City
Tehran
Province
Tehran
Postal code
1115117819
Phone
+98 21 3995 5555
Email
mahsa.karami.am@gmail.com
2
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Mahsa karami
Street address
Beheshti Ave
City
Tehran
Province
Tehran
Postal code
1576653517
Phone
+98 21 8855 6671
Email
mahsa.karami.am@gmail.com
3
Recruitment center
Name of recruitment center
Khanevadeh hospital
Full name of responsible person
Mahsa karami
Street address
Shariati Ave, Kaj Ave
City
Tehran
Province
Tehran
Postal code
1641116139
Phone
+98 21 7750 7512
Email
mahsa.karami.am@gmail.com
4
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Mahsa karami
Street address
Fatemi Ave, Etemadzadeh Ave
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
mahsa.karami.am@gmail.com
5
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Mahsa Karami
Street address
Sayyad Shirazi HWY
City
Tehran
Province
Tehran
Postal code
1668619551
Phone
+98 21 2254 9001
Email
mahsa.karami.am@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
مهسا کرمی
Street address
West 200 Ave, West 196 Ave ,West Tehranpars
City
Tehran
Province
Tehran
Postal code
1686933517
Phone
+98 21 7774 8531
Email
Mahsa.karami.am@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mahsa Karami
Position
Critical care nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
West Tehranpars, West 196 Ave, West 200 Ave
City
Tehran
Province
Tehran
Postal code
1686933517
Phone
+98 21 7774 8531
Email
mahsa.karami.am@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyyed Amirhosein Pshgooie
Position
Associate Professor, PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shariati Ave, Kaj Ave., Army Nursing College
City
Tehran
Province
Tehran
Postal code
1641116139
Phone
+98 21 8802 8350
Fax
Email
apishgooie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mahsa Karami
Position
Critical care nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
West Tehranpars, West 196 Ave, West 200 Ave
City
Tehran
Province
Tehran
Postal code
1686933517
Phone
+98 21 7774 8531
Email
mahsa.karami.am@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published