Objectives: To evaluate the effects of Rosa aromatherapy on sleep quality in menopausal women.
The study population: Menopausal women referred to the health centers in Urmia on the intervention and control groups Will be divided randomly into two. Sample size: 60 patients (30 Control, 30 Case).
Design: The implementation of the study will be four consecutive nights for 6 week for each person. Rose Aromatherapy will be performed every night for 4 drop and by sleep quality Index Pittsburgh before and after, in both groups ،compare the quality of patients' sleep.
Inclusion criteria: Passing at least one year from the last menstrual period; women without diabetes; hypertension; heart and respiratory disease etc.
Exclusion criteria: Dissatisfaction to participant in the study.
Main outcome measures :sleep quality parameters including subjective sleep quality; sleep latency; sleep duration; habitual sleep efficiency, sleep disturbances; use of sleeping medication; daytime dysfunction initial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111420778N4
Registration date:2016-09-02, 1395/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental (University of Medical Sciences of urmia)
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Rosa Damascene aromatherapy on sleep quality in menopausal women
Public title
Aromatherapy effect on sleep quality in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Consent to participate in the project; Passing at least one year from the last menstrual period; confirmed menopause; women without diabetes; hypertension; heart and respiratory disease; consumption sleep pills; hormone replacement therapy; mental disorders and Pittsburgh Sleep Quality Index score of 5 or above.
Exclusion criteria:
Dissatisfaction to participant in the study; Allergic signs and symptoms while taking aromatherapy; use Rose less than 4 times a week; detection of diabetes and hypertension during intervention; any major stressors.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
571478334
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
ir.umsu.rec.1394.293
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
G47
ICD-10 code description
Sleep Disorders
2
Description of health condition studied
Menopause
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Improve of sleep quality
Timepoint
Before intervention 6 weeks after intervention and 4 weeks after the cessation intervention
Method of measurement
Pittsburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Rosa Damascene
fragrance will be used by participants in the intervention group nightly before sleeping.
The fragrance will be dropped on cotton balls, which were placed on a cylindrical container at mothers’ disposal. Keeping the container
at a projected distance of 20 cm, the participants inhaled 10 deep breaths and then the container was placed beside their pillow until
morning. This procedure will be done 4 times a week for 6 weeks.. The
instrument for collecting data will be Pittsburgh sleep quality index; which will be completed at the baseline; fourth; and eighth weeks after the
intervention. Data Will be analyzed using independent t test and repeated measures analysis of variance calculated by SPSS 16.
Category
Treatment - Drugs
2
Description
Control group: no intervention will be performed in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia city health centers
Full name of responsible person
Somaye rezavand
Street address
Students' dormitory of Urmia University of Medical Sciences
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Urmia University of Medical Sciences
Full name of responsible person
Iraj mohebbi
Street address
Resalat biv,next to the emergency center، Urmia University of Medical Sciences
City
Urmia
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,Urmia 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
University of Medical Sciences of urmia
Full name of responsible person
Fateme Mogaddam Tabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nazloo Faculty of Midwifery and Nursing
City
Urmia
Postal code
Phone
+98 44 3275 4964
Fax
Email
fmtabrizi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences of urmia
Full name of responsible person
Fateme Mogaddam Tabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nazloo; Faculty of Midwifery and Nursing
City
Urmia
Postal code
Phone
+98 44 3275 4964
Fax
Email
fmtabrizi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Fateme MogaddamTabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)