Aromatherapy effect of head and face massage on delirium and sleep in patients with acute myocardial infarction hospitalized in cardiac intensive care unit: a parallel randomized clinical trial.
Determining the effect of aromatherapy of head and face massage on the incidence of delirium, quality and quantity of sleep in patients with acute myocardial infarction, hospitalized in cardiac intensive care units
Design
A parallel randomized clinical trial, because the patients will be included gradually and due to the non-uniformity of the sample size in the three groups, a simple random allocation method is used. The sample size is 199 people.
Settings and conduct
The study site will be Imam Hossein Hospital in Shahroud. Massage in the intervention groups will continue from the morning shift on the second day of the patient's hospitalization to the evening shift on the third day. The sleep questionnaire before the intervention and two days after the intervention and the delirium questionnaire after the intervention for 3 days will be completed at the end of each work shift in each group
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of acute myocardial infarction (AMI). Getting AMI for the first time. Age over 50 years. Exclusion criteria: Alcohol dependence. Confirmed vision and hearing problems. History of cognitive disorders and psychotic disorders (self-reported). Patient. Having all kinds of olfactory disorders confirmed by a doctor. Migraine headaches. History of head or face cancer. History of allergy to various oils used in massage therapy. History of seizures and epilepsy.
Intervention groups
In the first intervention group, massage therapy with lavender oil will be performed for patients twice a day and on two consecutive days. In the second intervention group, massage therapy with unscented sweet almond oil will be performed for the patients as in the first group, and in the control group, only routine treatments for delirium and sleep management will be performed.
Main outcome variables
Delirium and sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230909059382N1
Registration date:2024-02-12, 1402/11/23
Registration timing:registered_while_recruiting
Last update:2024-02-12, 1402/11/23
Update count:0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
Mehrnaz Kharatha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
kharatha@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aromatherapy effect of head and face massage on delirium and sleep in patients with acute myocardial infarction hospitalized in cardiac intensive care unit: a parallel randomized clinical trial.
Public title
The effect of facial massage aromatherapy on delirium and sleep in patients with acute infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of acute myocardial infarction (AMI) by a cardiologist.
having an acute myocardial infarction for the first time
Age over 50 years
Hospitalization in the CCU department
Exclusion criteria:
Alcohol dependence
Vision and hearing problems confirmed by a doctor
History of cognitive disorders and psychotic disorders as self-reported by the patient
History of taking psychoactive drugs such as anti-anxiety, anti-depressant, mood stabilizer, anti-psychotic drugs
The presence of skin problems, wounds and injuries on the patient's head or face
Having all kinds of olfactory disorders confirmed by a doctor
Suffering from migraine headaches
A history of advanced osteoporosis diagnosed by a specialist doctor
History of head or face cancer
History of allergy to various oils used in massage therapy, such as lavender and sweet almond oil
History of seizures and epilepsy
Transfer the patient to the ward
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
199
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the sequence of random allocation will be obtained by the methodology consultant with the software. Because the patients will enter the study gradually and due to the non-uniformity of the sample size of the three groups, a simple random allocation method will be used. The sequences obtained by the software will be placed in envelopes, according to the order in which people entered the study, numbers will be assigned to them. For each person, an envelope number corresponding to his own number will be opened, and in this way, the person's group will be determined. Qualified people will be registered by the first moderator and the allocation of participants to groups will be determined by the moderator based on the sequence of allocation hidden in the envelopes.
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 Shahroud university of medical science
Street address
Iran,shahroud,tehran street, shahroud university of medical science
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2024-01-12, 1402/10/22
Ethics committee reference number
IR.SHMU.REC.1402.164
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
2
Description of health condition studied
Sleep
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
delirium
Timepoint
From the evening shift on the second day of hospitalization after the last intervention at the end of the morning shift on the fourth day of hospitalization
On the morning of the second day of hospitalization at 9 am and on the morning of the third and fourth day of hospitalization at 9 am
Method of measurement
St Mary's Hospital Sleep (SMHSQ ) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: After obtaining the necessary letters of recommendation from Shahroud University of Medical Sciences, the researcher will select the patients who meet the criteria for entering the study, and after obtaining the informed consent, which will be filled by the patient himself, they will enter the study. First, to ensure that the patient is not allergic to lavender and sweet almond oil, we will perform a skin test with lavender and sweet almond oil on the inner part of the forearm, and then 5 to 10 minutes later, if the patient is not allergic, we will perform massage therapy with oil. We will do it on the patients. Massage therapy intervention including 13 combined techniques taken from Brown's massage therapy method will be used. In the first group of intervention, massage therapy with lavender oil twice a day at 10 am and 6 am. It will be done in the evening and on two consecutive days for patients. In total, each patient will receive 4 sessions, each session lasting 20 minutes. To perform massage therapy, the patient is placed in a semi-sitting position and the massage therapist stands in front of the patient's bed. Each massage movement will be repeated for 5 times. The massage of the patients in the intervention groups will start from the morning shift of the second day of the patient's hospitalization and will continue until the evening shift of the third day. After the intervention, the rate of delirium of the patients will be evaluated using the scale (NEECHAM) in such a way that the said scale will be completed from the evening shift on the second day of hospitalization (at the end of each work shift) and the last time at the end of the morning shift on the fourth day. and each patient will be evaluated six times in total. Their sleep quality and quantity were measured using Saint Mary's Sleep Quality and Quantity Questionnaire (SMHSQ) on the morning of the second day of hospitalization at 9:00 am (before the intervention) and on the morning of the third and fourth day of hospitalization at 9:00 am (after the intervention). A total of three lessons will be evaluated. And then the intensity of delirium and the quality and quantity of sleep in all three groups will be measured and compared at the end.
Category
Treatment - Other
2
Description
Intervention group 2: In this group, massage therapy with unscented sweet almond oil will be performed for patients twice a day at 10 am and 6 pm on two consecutive days. In total, each patient will receive 4 sessions, each session lasting 20 minutes. To perform massage therapy, the patient will be in a semi-sitting position and the massage therapist will stand in front of the patient's bed. Each massage movement will be repeated 5 times.
Category
Treatment - Other
3
Description
Control group: People in the control group received only routine treatments
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mehrnaz kharatha
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran,shahroud,tehran street, shahrood univercity of medical sciences
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
mehrnaz.kharatha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehrnaz kharatha
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran, shahroud,tehran street, shahrood university of medical science
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
mehrnaz.kharatha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehrnaz kharatha
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran, shahroud, tehran street, shahrood university of medical science
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
mehrnaz.kharatha@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some demographic information of patients can be shared after de-identifying individuals.
When the data will become available and for how long
After publishing an article.
To whom data/document is available
Project partners.
Under which criteria data/document could be used
People doing similar research work.
From where data/document is obtainable
The request to receive the documents is sent to the person in charge of the project(mehrnaz kharatha).Iran address. shahroud city. Tehran street. shahrood univercity of medical science. contact number: 00982332395054.postal code:3614773955
What processes are involved for a request to access data/document
After receiving the request,The data will be provided to the applicants immediately by email by the project manager.