Determination of the effect of aromatherapy with essential oil of Citrus aurantium on the sexual function of postmenopausal women referring to health centers in Ahvaz city
Design
Randomized clinical trial, with control group, double-blind, with parallel group
Settings and conduct
This study will perform on menopause women referred to health center of 17 shahrivar in Ahvaz. The intervention group is inhaling the essential oil 2 times (10 and 22 hours) in day for 4 consecutive days in a week, for 4 weeks and every time 5 minutes. The control group also uses a placebo in the same way. In this study, information analyzer and researcher blindness will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent to participate in the study, good psychological and mental status according to the clinician's diagnosis,Having at least ability to read and write
Exclusion criteria: Obtaining score of less than 5 in the sleep quality questionnaire
Intervention groups
Intervention group with Citrus aurantium (intervention group): The intervention group is inhaling the essential oil for 30 minutes at intervals of 5 minutes. Control group with almond: The control group is inhaling the almond oil for 30 minutes at intervals of 5 minutes.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027633N7
Registration date:2020-08-23, 1399/06/02
Registration timing:retrospective
Last update:2020-08-23, 1399/06/02
Update count:0
Registration date
2020-08-23, 1399/06/02
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
2019-07-17, 1398/04/26
Expected recruitment end date
2019-09-17, 1398/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Citrus aurantium aroma on sleep quality in menopausal women
Public title
The effect of Citrus aurantium aroma on 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 Citrus aurantium 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
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating subjects to the study groups (intervention and control) was done random block using six blocks. This was done with WinPepi11.0 software.This software generates random groups. In each block, 3 subjects were from the control group and 3 subjects were from the intervention group, which was arranged randomly.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.AJUMS.REC.1398.162
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 of essential oil (headache)
Timepoint
During the intervention
Method of measurement
Questionnaire made by the resercher
2
Description
Complications of essential oil (nausea)
Timepoint
During the intervention
Method of measurement
Questionnaire made by the resercher
3
Description
Complications of essential oil (dizziness)
Timepoint
During the intervention
Method of measurement
Questionnaire made by the resercher
Intervention groups
1
Description
Intervention group(Intervention group with Citrus aurantium): 2 times (10 and 22 hours) in day and every time 2 drops of essential oil at a concentration of 5% (made by Wares pharmaceutical company) for 4 consecutive days in a week, for 4 weeks on the skin of the forearm, to inhalation to get 5 minutes at 30 centimeters.
Category
Rehabilitation
2
Description
Control group (control group with Almond): 2 times (10 and 22 hours) in day and every time 2 drops of essential oil for 4 consecutive days in a week, for 4 weeks on the skin of the forearm, to inhalation to get 5 minutes at 30 centimeters.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Health Center
Full name of responsible person
Foruzan Sharifipour
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
sharifipour_fr91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
abbaspoor-z762@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Foruzan Sharifipour
Position
Ph.D. student of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
sharifipour_fr91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
abbaspoor-z762@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Foruzan sharifipour
Position
Ph.D. student of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
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