Comparison of the effect of lavender and Salvia Officinalis aroma on the sleep quality of postmenopausal women
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 159 patients.
Settings and conduct
This study will perform on menopause women referred to health centers. The intervention group for 3 nights in a week, for one month, 2 drops of essential oil that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening. The control group also uses a placebo in the same way. in this study, researcher and data analyzer blindness will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study and through at least one year since the last menstruation.
Non-entry criteria: sensitivity to lavender, salvia officinalis and almond oil history of allergic rhinitis and known respiratory problems such as asthma.
Intervention groups
Intervention group with Salvia Officinalis (intervention group): for 3 nights in a week, for one month, 2 drops of essential oil of salvia that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening.
Intervention group with Lavender (intervention group):this group uses lavender essential oil in the same way.
Control group with Almond (control group):The control group also uses a placebo containing Almond oil in the same way.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027633N11
Registration date:2024-06-14, 1403/03/25
Registration timing:prospective
Last update:2024-06-14, 1403/03/25
Update count:0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavender and Salvia Officinalis aroma on the sleep quality of postmenopausal women
Public title
Comparison of the effect of lavender and Salvia Officinalis aroma on the sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Acquiring the sleep quality questionnaire score ≥ 5
Through at least one year since the last menstruation
Having enough literacy to fill out a questionnaire
Age of at least 45 years
Exclusion criteria:
Occurrence of stressful incidents in the past six months
Use of drugs, tobacco and alcohol
Physical and mental illness
Sensitivity to lavender, Salvia Officinalis and almond oil
History of allergic rhinitis and known respiratory problems such as asthma
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of subjects to study groups (two intervention groups and one control group) will be done by block randomization method and using blocks of 6. This will be done with WinPepi11.0 software. This software generates random groups. In each block, 2 subjects will belong to the control group, 2 subjects will belong to the intervention group with salvia and 2 subjects will belong to the intervention group with lavender, and their order will be random. We will have 26 blocks of 6 and one block of 3 with ratio of 1:1:1.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blindness is not possible for the participant. Therefore, in this study, researcher and data analyzer blindness (lack of knowledge of the subject code) will be used, so the study will be double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti
City
Kermanshah
Postal code
6715847141
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.KUMS.REC.1403.101
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality
Timepoint
Before and after the end of the intervention period
Method of measurement
Sleep quality questionnaire of Pittsburgh
Secondary outcomes
1
Description
Complications(dyspnea, headache, dizziness, nausea and vomiting)
Timepoint
During the intervention
Method of measurement
Questionnaire made by the researcher
Intervention groups
1
Description
Intervention group: The aromatherapy with essence of Salvia Officinalis with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of essence of Salvia Officinalis of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening.
Category
Rehabilitation
2
Description
Intervention group: The aromatherapy with essence of Lavender with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of essence of Salvia Officinalis of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening.
Category
Rehabilitation
3
Description
Control group: The aromatherapy with almond oil with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of almond oil of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah City Health Center
Full name of responsible person
Foruzan Sharifipour
Street address
Shahid Beheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 2987
Email
sharifipour_fr91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sirus Jalili
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Foruzan Sharifipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isar Square, Daulat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3828 2101
Email
sharifipour_fr91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Susan Heydarpour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Dolat Abad, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Email
s.heydarpour1394@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foruzan sharifipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isar Square, Daulat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3816 2538
Email
sharifipour_fr91@yahoo.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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available