Comparison of the effect of oral capsule and aroma of lavender on the quality of sleep in perimenopausal women
Design
Clinical trials with control group, with parallel groups, Randomized, placebo-controlled, single-center. Sample size was 30 patients (2 groups of 15 control and intervention).
Settings and conduct
The study site is the Tuba Clinic in Sari city.
Lavender essential oil with 100% concentration was used for the intervention group and 250 mg placebo capsule for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 39-51 in transient menopausal period; Healthy sense of smell; No taking sleeping pills during the last month.
Exclusion criteria: Drug addiction; History of mental disorders; History of asthma, bronchitis, chronic respiratory diseases.
Intervention groups
Intervention group: Lavender essential oil with 100% concentration (Barij Herbal Medicines Company of Kashan) is placed on a 2x2 piece of gas when going to bed at night and attaches to the patient's collar.
Control group: 250 mg placebo capsule (brand name Linazepam) given to patients when going to bed at night.
Main outcome variables
Sleep Quality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N47
Registration date:2019-12-18, 1398/09/27
Registration timing:registered_while_recruiting
Last update:2019-12-18, 1398/09/27
Update count:0
Registration date
2019-12-18, 1398/09/27
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-19, 1398/08/28
Expected recruitment end date
2020-05-17, 1399/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral capsule and aroma of lavender on the quality of sleep in perimenopausal women
Public title
Comparison of the effect of oral capsule and aroma of lavender on the quality of sleep in perimenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 39-51 in transient menopausal period
Healthy sense of smell
No taking sleeping pills during the last month
Exclusion criteria:
Drug addiction
History of mental disorders
History of asthma, bronchitis, chronic respiratory diseases
Age
From 39 years old to 51 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.SEMUMS.REC.1398.201
Health conditions studied
1
Description of health condition studied
Sleep
ICD-10 code
F51.12
ICD-10 code description
Insufficient sleep syndrome
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before intervention and after intervention (one month later)
Method of measurement
PSQI- Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lavender essential oil with 100% concentration (Barij Herbal Medicines Company of Kashan) is placed on a 2x2 piece of gas when going to bed at night and attaches to the patient's collar.
Category
Treatment - Other
2
Description
Control group: 250 mg placebo capsule (brand name Linazepam) given to patients when going to bed at night.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba Clinic
Full name of responsible person
Mohammadreza Asgari
Street address
Former School of Medicine, Khazar Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4816895195
Phone
+98 11 3324 0003
Email
asgari5000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyedeh Razieh Pourhasham
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available