Determine the effects of aromatherapy with Salvia Officinalis on sleep quality in menopausal women
Design
This randomized double -blind clinical trial with parallel groups study will perform on 60 menopause women referred to health centers of Kermanshah with the aim of investigating the effects of aromatherapy with Salvia Officinalis on sleep quality in menopausal women. At the beginning of the study, each person is assigned a code of 1 or 2, and the individuals with code 1, the control group and the code-holders 2 form the intervention group. Each eligible person for inclusion in the study randomly takes one of these cards with the codes written on it. In this way, the random allocation of patients to each group is determined.
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 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. 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
Individuals should be allowed to enter the study who benefit most from the intervention . People who may be harmed by the intervention should not be included in the study.
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.
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:IRCT20160427027633N4
Registration date:2018-08-12, 1397/05/21
Registration timing:prospective
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Salvia Officinalis aromatherapy on sleep quality in menopausal women
Public title
Effect of Salvia Officinalis aroma on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ages 45 to 65 years old
through at least one year since the last menstruation
not having a history of allergic rhinitis and known respiratory problems such as asthma
the absence of physical and mental illness
non-use of drugs, tobacco and alcohol
Non-occurrence of stressful incidents in the past six months
Exclusion criteria:
the appearance of any physical and psychological illness during the study that causes sleep disorder
the appearance of a significant change in sleep conditions unpredictably (divorce, death and travel)
the sensation of Salvia aroma during the study
Lack of the program performance for a maximum of one week during the study
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study, Simple randomization method is used for random allocation (hiding allocation). In this way, 60 cards matched in appearance are prepared and 30 of them have the number or code 1 that specifies the group "Intervention based on essence of Salvia Officinalis" and on 30 others of them the number or code 2 which specifies the control group(Distilled water
) is written. Then, each eligible person for inclusion in the study randomly takes one of these cards with the codes written on it. In this way, the random allocation of patients to each group is determined without letting the participants to know the nature of the numbers 1 or 2 in the type of intervention that will be assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, to hide the allocation of aromas (essence of Salvia Officinalis) and placebo (Almond oil) Opaque envelopes sequentially numbered are used.Each envelope contains a glass of essence of Salvia Officinalis or placebo.Medications were placed on the envelope in the randomized allocation sequence by the person not involved in the study. Investigating individuals to study and delivering envelopes are done by the researcher himself from Nos. 1 to 60. 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
Province
Kermanshah
Postal code
6715847141
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.KUMS.REC.1397.234
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
Pittsburgh questionnaire
Secondary outcomes
1
Description
Complications
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
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
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Health Center
Full name of responsible person
foruzan sharifipour
Street address
Dolat Abad
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 3049
Email
sharifipour_fr91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shaid Beheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
fnajafi@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
60
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
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Amir Kabir Ave
City
Kermanshah
Province
Kermanshah
Postal code
6719917164
Phone
+98 83 3827 5239
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
Foruzan sharifipour
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Amir Kabir Ave
City
Kermanshah
Province
Kermanshah
Postal code
6719917164
Phone
+98 83 3827 5239
Email
sharifipour_fr91@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
Lecture
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
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