The aim of this study is to determine the effect of aromatherapy with lavender essential oil on depression and headache disability in migraine patients. This randomization clinical trial study are conducted on 80 migraine patients referred to Tooba clinic.Patients Including major criteria: being over 18 years; alertness and ability to communicate; at least 6 months of having migraine headache; having good snse of smell according to the neurological examination; having criterias of migraine without aura according to the classification of the International headache society (IHS); don't using psychiatric drugs specially anti-depressants drugs; under prophylactic treatment by Depakin 500 produced by Sa nofi aventis one time every night. Patients eligibility major criteria: pregnancy or decision to pregnancy;record of allergies;incidence of allergy during intervention. At first, Beck depression scale and headache disability scale will be used for the assessment of depression and headache disability. Experimental group: experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO/IEC 17025 at a concentration of 100 percent for 4 week. A cotton ball soaked with 2 drops of lavender essential oil will be put on the collar of patients and will be asked to breath normally for 15 minutes three times a week ( even days). Control group : Control group will be exposed to the inhalation of liquid paraffin produced by Kimiagar Toos. A cotton ball soaked with 2 drops of liquid paraffin as a placebo will be put on the collar of patients and will be asked to breath normally for 15 minutes three times a week (even days) until 4 weeks. Depression and headache disability scales will be complete in the end of 2nd and 4th week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608117494N22
Registration date:2017-08-22, 1396/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-22, 1396/05/31
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Mazandaran University of Medical Scienes.
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with lavender essential oil on depression and headache disability in migraine patients
Public title
Effect of lavender on depression and headache disability in migraine patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: being over 18 years; alertness and ability to communicate; at least 6 months of having migraine headache; don't have a cold; don't using perfume before and during the intervention; having good snse of smell according to the neurological examination; having criterias of migraine without aura according to the classification of International headache society (IHS); don't using psychiatric drugs specially anti-depressants drugs; Under prophylactic treatment by Depakin 500 produced by Sa nofi aventis one time every night, under treatment of acute phase of headache by NSAID at the incidence of headache .
Exclusion criteria: pregnancy or decision to pregnancy; record of allergies; Acute respiratory disease; addiction; allergy during intervention.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Mazandaran university of medical science
Street address
Moalem street , Moalem Square
City
Sari
Postal code
Approval date
2016-12-12, 1395/09/22
Ethics committee reference number
IR.MAZUMS.REC.95.2439
Health conditions studied
1
Description of health condition studied
migraine patients
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura[commen migraine
Primary outcomes
1
Description
Depression
Timepoint
Before intervention first week, two weeks after intervention and four weeks after intervention
Method of measurement
Beck Depression scale
2
Description
Headache disability
Timepoint
Before intervention first week, two weeks after intervention and four weeks after intervention
Method of measurement
Headache disability inventory
Secondary outcomes
1
Description
Allergic to lavender
Timepoint
During four weeks of intervention
Method of measurement
Questions from patients
Intervention groups
1
Description
Control group: patients will be exposed to the inhalation of liquid paraffin produced by Kimiagar Toos Company. In experimental group a ball soaked with 2 drops of liquid paraffin will be attached to the collar of patient three times a week (even days: Saturday,MondayandWednesday) for four weeks and will be asked to breath normally every time for 15 minutes.
Category
Treatment - Drugs
2
Description
Experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO/IEC 17025. Lavender essence is produced from fresh flowering parts of the plant which contains Linalool, Linalool acetate, Caffeic acid and Tannins. In experimental group a cotton ball soaked with 2 drops of lavender essential oil with concentration of 100 percent will be attach to collar of patient three times a week (even days: Saturday,Monday and Wednesday) for 4 weeks and will be asked to breath normally every time for 15 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba clinic (Baghban)
Full name of responsible person
Azar jafari koulaee, Fatemeh Khenarinezhad
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Moalem street, Moalem square
City
Sari
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 Mazandaran 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
Mazandaran University of Medical science
Full name of responsible person
Azar jafari Koulaee
Position
Nursing student
Other areas of specialty/work
Street address
Vesal street, School of nursing and midwifery Mazandaran University of Medical sciences
City
Sari
Postal code
Phone
+98 11 3329 4601
Fax
Email
jafari.azar74@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical sciences
Full name of responsible person
Dr Masoumeh Bagheri-Nesami
Position
Associate Professor
Other areas of specialty/work
Street address
Sari, Vessal street, School of nursing and midwifery Mazandaran University of Medical sciences
City
Sari
Postal code
Phone
+98 11 3336 7345
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)