The purpose of this study was to investigate the effect of inhaled lavender on the symptoms of menopause. The subjects were 100 cases of post menopausal women 45-55 years old at selected health care centers in Ardebil. After getting written informed consent, participants were complete the demographic characteristics. Then they allocated them into intervention and control groups using permuted block randomization with block sizes of four and six in sequentially numbered. Participants were asked to note number of daily flushing for 1 week. Then intervention group received bottles envelopes containing 20 cc Lavender twice on weekly 20 minute and control group received the same treatment but with diluted milk only. Participants were complete green scale 12 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011816255N1
Registration date:2015-01-19, 1393/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-19, 1393/10/29
Registrant information
Name
Roya Nikjou
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 1771 7137
Email address
roya.nikjou@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Ardebil University of Medical Sciences
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inhaled lavender compared with diluted milk on menopausal symptoms in postmenopausal women 45 to 55 years old
Public title
Effect of inhaled lavender compared with diluted milk on menopausal symptoms in postmenopausal women 45 to 55 years old
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The age range is 45 to 55 years; During the past 12 months have not menstrual periods; With minimum score of 15 to maximum of 42 in green score; Absence of disease or a history of breast cancer; No use of hormonal or herbal drugs for relief of menopausal symptoms or other neurological drugs in the 2 past months or during the study; The lake of sensitivity to spices or essences; No smoking and do not drinking alcohol. Exclusion criteria: Medical complications during the study
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
University Street, Ardebil
City
Ardabil
Postal code
5618985991
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
Arums.Rec.93.38
Health conditions studied
1
Description of health condition studied
Early symptoms of menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climactric states
Primary outcomes
1
Description
Vasomotor symptoms
Timepoint
One week befor and 12 weeks after intervention
Method of measurement
Green scale
Secondary outcomes
1
Description
Physical symptoms
Timepoint
One week befor and 12 week after intervention
Method of measurement
Green scale
Intervention groups
1
Description
Intervention group: Received lavender twice on weekly 20 minute.
Category
Prevention
2
Description
Control group: Received diluted milk twice on weekly 20 minute.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Health Care Centers
Full name of responsible person
Roya Nikjou
Street address
Ardabil Health Care Centers
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Ardabil University of Medical Science
Full name of responsible person
Hadi Piry dogaheh
Street address
University Street
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ardabil University of Medical Science
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
Ardabil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
MSC in Midwifery, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Shohada street, Faculty of Nursing and Midwifery
City
Ardabil
Postal code
56157-54136
Phone
+98 45 1771 7137
Fax
+98 45 1772 8004
Email
roya.nikjou@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
Master of Sciences in Midwifery
Other areas of specialty/work
Street address
Shohada street, Faculty of Nursing and Midwifery
City
Ardabil
Postal code
56157-54136
Phone
+98 45 1771 7137
Fax
+98 45 1772 8004
Email
roya.nikjou@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
Master of Sciences in Midwifery
Other areas of specialty/work
Street address
Shohada street, Faculty of Nursing and Midwifery
City
Ardabil
Postal code
56157-54136
Phone
+98 45 1771 7137
Fax
+98 45 1772 8004
Email
roya.nikjou@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)