Objective: Comparing the effect of three methods of inhalation aromatherapy, massage and aromatherapy in combination with massage on sleep quality of cardiac patients hospitalized in Imam Ali and Imam Reza hospitals.
Design: randomized controlled clinical trial. Setting and conduct: required sample size is 200 patients. Eligible patients will be allocated to one of the four groups of inhalation aromatherapy, massage, aromatherapy in combination with massage and control group by block randomization.
Inclusion criteria include Consent to participate in the study; not having skin disorders and eczema; Stable vital signs; Lack of allergies; not having coagulation and bleeding disorders; not having mental disease and no history of hospitalization in psychiatric wards; not being sensitive to hand and foot massage and aromatherapy; score equal to or more than five from the Pittsburgh quality of sleep questionnaire and positive smell test. Exclusion criteria include death or discharge; critically ill patient during the study; the patient's unwillingness to continue cooperation and oxygen administration for patients.
Interventions: Initially the quality of sleep questionnaire will be completed by patients. The study will be conducted for seven consecutive nights; at bedtime. In group one; inhalation of lavender essential oil will be done for 20 minutes. In group two; massage with sweet almond Oil will be performed for 20 minutes. In group three, massage is performed for 20 minutes, using a combination of lavender and sweet almond oil. Control group will receive routine cares. In the morning of the eighth day, the Pittsburgh Sleep Quality questionnaire will be completed again by the patients.
The main outcome variables: quality of sleep.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603094736N12
Registration date:2017-01-05, 1395/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-05, 1395/10/16
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of three methods of inhalation aromatherapy, massage and aromatherapy massage on sleep quality of cardiac patients
Public title
The effect of three methods of inhalation aromatherapy، massage and aromatherapy massage on cardiac patients' sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Consent to participate in the study; not having skin disorders and eczema; Stable vital signs; Lack of allergies; not having coagulation and bleeding disorders; not having mental disease and no history of hospitalization in psychiatric wards; not being sensitive to hand and foot massage and aromatherapy; score equal to or more than five from the Pittsburgh quality of sleep questionnaire and positive reaction to smell. Exclusion criteria: death or discharge; critically ill patient during the study; the patient's unwillingness to continue cooperation and oxygen administration for patients.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
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 Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Postal code
6714634698
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
KUMS.RES.1395.511
Health conditions studied
1
Description of health condition studied
Cardiac disease
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
2
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
3
Description of health condition studied
Heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure
4
Description of health condition studied
Acute pulmonary edema
ICD-10 code
I50.1
ICD-10 code description
Acute pulmonary edema
Primary outcomes
1
Description
sleep quality
Timepoint
At the beginning of the study and eighth day
Method of measurement
Pittsburgh sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: In group I, before going to sleep at 10 P.M. two drops of lavender essential oil with the trade name of lavender essential oil and scientific name of Lavandula stoechas, manufactured by Barij Essence Company, will be dropped on a napkin and will be attached to the patient's cloth by the clamp in the chest area for 20 minutes and this process will be repeated for seven nights. This essence will be inhaled by the patient. This essential oil will be used in the pure form with 100 percent concentration. linalyl acetate and linalool are the major chemical compounds of this essence.
Category
Other
2
Description
Intervention 2: In group 2, using sweet almond oil manufactured by Barij essence company, hands and feet ( from the planter surface of the foot up to the knee and the palm of the hand up to elbow ) are given massage by the trained nurse with the same sex for 20 minutes. The oil used in this kind of massage is sweet almond oil with the scientific name of Prunus amygdalus var dulcis and the trade name of sweet almond oil. This oil is manufactured by Kashan Barij Essence Company. The main component of this oil is glyceryl oleate.
Category
Other
3
Description
Intervention 3: in group 3, using a combination of sweet almond oil and lavender ( 10-15 ml sweet almond oil mixed with lavender, dilution of 1/5 percent ) hands and feet ( from the planter surface of the foot up to the knee and the palm of the hand up to elbow ) are given massage by the trained nurse with the same sex for 20 minutes. The oil used in this kind of massage is sweet almond oil with the scientific name of Prunus amygdalus var dulcis and the trade name of sweet almond oil. This oil is manufactured by Kashan Barij Essence Company. The main component of this oil is glyceryl oleate.
Category
Other
4
Description
Control group: The control group will receive usual care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali and Imam Reza Hospitals of Kermanshah
Full name of responsible person
Alireza khatony
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshty street, Kermanshah, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education-Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer street
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)