The objective of this study is to determine the effect of lavender aromatherapy on stress and fertility rate in infertile women who are candidate for In vitro fertilization (IVF). This study, clinical trials, single-blind, placebo- control, single center are conducted in Arash women's hospital. In the pilot study section , among women with infertility who will scheduled for IVF 40 women participated in this study and divided in the two groups (BMI- matched). Exclusion criteria include having anatomical abnormalities in the head and neck, especially nose area or any condition that interferes with the sense of smell. Before IVF the percent of total body fat mass, visceral fat, the rate of metabolism at rest (RMR) and BMI were measured for all participants by Body Composer Monitor-omron (Made in Japan, Model 511 BF). Half an hour before IVF procedure in Lavender group, women smell a piece of cotton with 5 drop of Lavender (that placed in a glass bottle) in 10 centimeter distance from their noise for 5 minute. In control group, participants smell a piece of cotton with inter substance. Standardized questionnaire to evaluate Depression and Anxiety before the intervention and immediately before IVF are completed by patients. Then the intensity of anxiety and infertility rate are compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404081952N4
Registration date:2014-04-19, 1393/01/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-22, 1393/02/02
Expected recruitment end date
2015-04-22, 1394/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on stress and fertility rate in infertile women who are candidate for In Vitro Fertilization (IVF)
Public title
The effect of lavender smelling on stress and fertility rate in infertile women who are candidate for In Vitro Fertilization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: infertile women who are candidate for In Vitro Fertilization (IVF). Exclusion criteria: having anatomical abnormalities in the head and neck, especially nose area or any condition that interferes with their sense of smell
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-07-16, 1392/04/25
Ethics committee reference number
92-01-39-21705-89412
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The rate of anxity
Timepoint
Before and after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Half an hour before IVF procedure, women smell a piece of cotton with 5 drop of Lavender (that placed in a glass bottle) in 10 centimeter distance from their noise for 5 minute
Category
Treatment - Drugs
2
Description
Control group: Half an hour before IVF procedure, women smell a piece of cotton with 5 drop of inter substance (that placed in a glass bottle) in 10 centimeter distance from their noise for 5 minute
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Dr Afsaneh Moini
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr akbare Fotohi
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences , Deputy of Research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Ashraf Moini
Position
Professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
hosp_arash@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ashraf Moini
Position
Professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran