The effect of Inhalation Aromatherapy with Lavender Essential oil on some of menopausal symptoms and quality of life in post-menopausal women under coverage of Isfahan,s selected health care center in 2017
1) The objective of present study is determining of the effect of lavender aromatherapy on some menopausal symptoms and quality of life in postmenopausal women. 2) Design: The study is a randomized with both control and intervention group this clinical randomized, placebo-controlled clinical trial. 3) Setting and conduct: 62 menopausal women who have Kupperman Index Score> admitted in the Health Centers No. 1 and 2 in Isfahan City ) will be randomly placed in the intervention and control groups. 4) Participants including have major inclusion criteria: Amenorrhea>12 month and<5 year duration, Kupperman Index Score>15, Able to give informed consent (Able to read and write) No history of herbal allergy and lack of respiratory problems. 5) Intervention: seventy menopausal women are the study samples and after one week of monitoring, are randomized blindly to Inhaled Lavender essence(The interventional group and placebo (control group). They should inhale 6 hours for 4 weeks continued every night. 6) Main outcome measures: The primary outcomes variable are menopausal symptoms and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081535706N1
Registration date:2017-09-05, 1396/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-05, 1396/06/14
Registrant information
Name
Mozhgan Jokar Jokar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7502
Email address
mozhgan_jokar@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
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 Inhalation Aromatherapy with Lavender Essential oil on some of menopausal symptoms and quality of life in post-menopausal women under coverage of Isfahan,s selected health care center in 2017
Public title
The effect of Inhalation Aromatherapy with Lavender Essential oil on some of menopausal symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Main Inclusion criteria: Amenorrhea>12 month and<5 year duration, Kupperman Index Score15؛ Able to give informed consent (Able to read and write)؛ No history of herbal allergy and lack of respiratory problems such as asthma؛ Main non-inclusion criteria and exclusion: do not use lanender essence for more than three nights a month؛ do not have willing to countinue during the study .
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Iran
City
Isfahan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IR.IUMS.rec.1395.2.055
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female Climacteric
Primary outcomes
1
Description
Menopausal Symptoms
Timepoint
Befor and After Intervention
Method of measurement
Copperman Scale
Secondary outcomes
1
Description
Quality Of Life In Menopausal Women
Timepoint
bBefor and After intervention
Method of measurement
Quality Of Life In Menopausal Women
Intervention groups
1
Description
Interventional group were randomized blindly to Inhaled Lavender essence during sleeping, 6 hours for 8 weeks.
Category
Placebo
2
Description
were randomized blindly to Inhaled Sunflower oil as placebo during sleeping
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers No. 2 in Isfahan City
Full name of responsible person
Zamaneh Vafayi
Street address
Saikh Mofid Crossroad, Faiz Street, Isfahan city
City
Isfshsn
2
Recruitment center
Name of recruitment center
Health Centers No. 1 in Isfahan City
Full name of responsible person
Mohamma Hassan Baradaran
Street address
Saikh Mofid Crossroad, Faiz Street, Isfahan city
City
Isfshsn
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences.
Full name of responsible person
Seyed Mohammad Hashemi
Street address
Isfahan University of Medical Sciences, Hezarjerib street,Isfahan, Iran
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences.
Full name of responsible person
Mozhgan Jokar
Position
Ttrainer Of Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjerib street,Isfahan, Iran
City
Isfahan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 7502
Fax
Email
nurse_jokar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences.
Full name of responsible person
Mozhgan Jokar
Position
Nursing Master of Science
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjerib street,Isfahan, Iran
City
Iiisfshsn
Postal code
00983137927502
Phone
+98 31 3792 7502
Fax
Email
nurse_jokar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mozhgan Jokar
Position
Nursing Master of Science
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjerib street,Isfahan, Iran
City
Isfahan
Postal code
00983137927502
Phone
+98 31 3792 7502
Fax
Email
nurse_joker@yahoo.commozhgan_jokar@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)