This study aims to examine the effects of aromatherapy using lavender essential oil on the quality of sleep among the menopause women. This research is a clinical trial conducted on(76 ) menopause women. Participants were randomly categorized into two groups of intervention and control (n=38)grop, Pittsburgh Sleep Quality Index (PSQI) was used for data gathering and was administered to both groups before and after aromatherapy. Inclusion criteria involved subjects passed 1 year of menopause, no background of asthma and allergy to flowers, no background of mental and physical disorders, no use of drug and alcohal. Exclusion criteria involved disease in research, allergy to Lavender aromatherapy, not aromatherapy for one week. Lavender essential oil used by in intervention group and distilled water was used as placebos in group control. The participants were asked to apply 2 drops of lavender essential oil or distilled water on a piece of cotton wool and place it beneath the exterior of their pillows for 3 nights in a week for 4 weeks. PSQI was completed by each subject of both groups after the intervention .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022321204N1
Registration date:2015-04-05, 1394/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-05, 1394/01/16
Registrant information
Name
Farzaneh Gholamalian
Name of organization / entity
Ahvaz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 613738331
Email address
gholamalian.fa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapour University of Medical Sciences and FacultyVice chancellor for research, Ahvaz of Arvand. Dr.Mostafa Feghhi.
Golestan highway,Ahvaz, Khuzestan, Iran, Islamic Republic Of
61357-15794
00989134083774
00986113361544
mfeghhi@ajums.ac.ir
Expected recruitment start date
2015-02-22, 1393/12/03
Expected recruitment end date
2015-04-23, 1394/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aromatherapy with lavender oil on sleep quality in menopause women
Public title
Effect of Aromatherapy on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pass 1 year of menopause; having poor sleep quality; have not cure disease; have not deppration; use not drug&alcohalland cigrate; not use hormontherapy, addiction to drugs, herbal remedies and alternative medicimn for 6 monthes ago.
Exclusion criteria:History of early-menopause(<40); allergies to aromatherapy and lavender; smell disorders, reniit and asthma, history of psychiatric disorders; bad happen and situation; dont aromatherapy for one week.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
N/A
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
Ethic committee Ahvaz University of Meddical Science
Street address
Golestan highwey
City
Ahvaz
Postal code
iran
Approval date
2015-02-21, 1393/12/02
Ethics committee reference number
ajums.REC.1393.412
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
G47.9
ICD-10 code description
Sleep Disorder, Unspecified
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before intravertion, After 4 weeks
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
No
Timepoint
No Act
Method of measurement
No
Intervention groups
1
Description
Intervention grop: Treatment for3 night in the week continue for4 weekes2 drops of lavender essential oil product by "Barij Esans" Of kashan with quality certifed ISO9001 and have estandard IEC17/ISC,of stoech category floweres piece of cotton wool and place it beneath the exterior of their pillows on the participant’s pillow at night.
Category
Treatment - Other
2
Description
control group: 2 drop of plassebo( Distilled water )for3 night in the week continue for4 weekes, piece of cotton wool and place it beneath the exterior of their pillows .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Num 2 East, Health Center
Full name of responsible person
Farzaneh Gholamalian
Street address
"7 tir"Park, Rastegary Street, Behbahani highwey
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences and Faculty of Arva
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Golestan highway
City
Ahvaz
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, Ahvaz Jundishapour University of Medical Sciences and Faculty of Arva