Protocol summary

Summary
main outcome: This research is a clinical trial study that The aim of this study was to investigate the effect of essential oil of mohammadi flower on hypertension in 70 patients with hypertension in the city of Baharman. Patients with major conditions of entry into the study include the risk of having a blood pressure by controlling the blood pressure recorded in the previous three periods; Having primary blood pressure; Having hypertension in stage 1 and 2; Healthy feeling; Not sensitized to the essential oil of Mohammadi flower and a history of allergy or respiratory illness are included in the study. Also, the main outcomes of the study include the patient's unwillingness to continue the study; Sensitization during the implementation of the plan; Lack of cooperation in referring to the health center for controlling blood pressure; Neuropsychiatric patients taking medication and illnesses that cause the patient to use drugs that alter blood pressure during research. Design: After selecting eligible samples, patients will be divided into two intervention and control groups by random allocation method. Data gathering tool was a demographic questionnaire, digital blood pressure device. Setting and conduct: At the beginning of the work, the necessary permissions will be obtained from the Ethics Committee's officials and then all patients with hypertension with personal desire and consent will be studied after completing the demographic information questionnaire and according to entry criteria. Based on filtered and odorless sesame oil, 1% dilution is provided by the pharmaceutical company Baryj Essence. It is supplied to the aroma group in separate ejaculators for 2 weeks. In the placebo group, the filtered and non-odor sesame oils prepared by Barij Essence Pharmaceutical Company will be used in separate ejaculators for 2 weeks of use. Intervention: In the Aroma group, patients undergo aromatherapy for cotton for 2 minutes and for 2 weeks by inhalation. In the test group and placebo, aromatherapy is performed at a distance of 5 cm from the nose. The procedure for performing aromatherapy at home is described to patients. Patients' blood pressure is taken one day before the intervention, after a ten minute rest from the left arm with a digital blood pressure device. Blood pressure measurement begins after the start of the aromatherapy days 2, 5, 9, 12, and 16 [31] (Monday, Thursday, Monday, Thursday and Monday) and is followed by ten minutes of rest by a specific person at the clinic (On Clock Specified ). The pulse rate of patients is also recorded in the form with the patient's blood pressure. In order to ensure the use of the extract, the checklist for thoroughly performing aromatherapy by the patients is completed and delivered to the researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060422320N2
Registration date: 2017-10-03, 1396/07/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Rafsanjan University of Medical Sciences Emam Ali Blvd, Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-05-26, 1396/03/05
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with essential oils of rose on blood pressure in patients with hypertension Bahraman city of Rafsanjan in 2016
Public title
The effect of aromatherapy with essential oils of rose on blood pressure in patients with hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Major entry into the study includes the fact that blood pressure is detected by controlling the blood pressure recorded in the previous three periods; Having primary blood pressure; Having hypertension in stage 1 and 2; Healthy feeling; Not having sensitivity to the essential oil of the flower of Mohammadi and a history of allergies or respiratory diseases. The main outcomes of the study include the patient's reluctance to continue studying; Sensitization during the implementation of the plan; Lack of cooperation in referring to the health center for controlling blood pressure; Neuropsychiatric patients taking medication and illnesses that cause the patient to use drugs that alter blood pressure during research.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

2

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences ethics committee
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Postal code
7718796755
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.RUMS.REC.1395.167

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
IX 110
ICD-10 code description
Essential (primary) hypertension Incl.: High blood pressure

Primary outcomes

1

Description
hypertension
Timepoint
Before the intervention, 2,5,9,12 days after, two days after intervention
Method of measurement
Blood pressure in millimeters of mercury using a digital blood pressure

Secondary outcomes

1

Description
pulse
Timepoint
Before the intervention, 2,5,9,12 days after, two days after completion of the intervention
Method of measurement
In terms of pulse rate using a digital blood pressure

Intervention groups

1

Description
In the control group, sesame oil is filtered and odorless as a placebo. Patients are subjected to aromatherapy for 2 consecutive days for 2 minutes and for 2 weeks by inhalation, three drops of placebo on cotton, at a distance of 5 cm from the nose under the aromatherapy. One day before the intervention, the blood pressure of the patients is taken with a digital blood pressure device. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays) after the start of aromatherapy, and the ten minutes of rest are performed by a specific person at the clinic. To ensure the use of placebo, the checklist for the exact completion of aromatherapy is completed by the patient and delivered to the researcher.
Category
Placebo

2

Description
In the aroma group, the essential oil of Mohammadi is diluted on the basis of filtered sesame oil, and is used as an additive. Patients in the aroma group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation. One day before the intervention, the blood pressure of the patients is taken with a digital blood pressure device. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. To ensure essential oil consumption, the exact checklist for aromatherapy is completed by the patient and delivered to the researcher.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center martyr Bahonar Bahreman Noogh
Full name of responsible person
Fereshte Sharifi
Street address
Health Center martyr Bahonar Bahreman, Ayatollah Hashemi Rafsanjani Blvd, Imam Hossein Square, Bahreman, Noogh
City
Bahreman

2

Recruitment center
Name of recruitment center
Health Center martyr Rajai Javadieh Noogh
Full name of responsible person
Azam Khajebeigi
Street address
Health Center martyr Rajai Javadieh Noogh, Health center Avenue, Javadieh Fallah, Noogh
City
Javadieh Noogh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research, Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Shamsizade Ali
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, Rafsanjan 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Assistant Professor, School of Nursing and Midwifery, Rafsanjan
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Postal code
7718796755
Phone
+98 34255900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Web page address
WWW.RUMS.AC.IR

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...