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, two blinded, has a control group, with a parallel group
Settings and conduct
This study will perform on menopause women referred to health centers.The intervention group 2 times (10 and 22 hours) in day and every time 2 drops of essential oil at a concentration of 5% 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. The control group also uses a placebo in the same way. in this study, participant and researcher 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 Citrus aurantium (intervention group): 2 times (10 and 22 hours) in day and every time 2 drops of essential oil at a concentration of 5% 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.
Control group with Almond (control group): 2 times (10 and 22 hours) in day and every time 2 drops of essential oil at a concentration of 5% 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.
Main outcome variables
sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027633N5
Registration date:2019-04-17, 1398/01/28
Registration timing:prospective
Last update:2019-04-17, 1398/01/28
Update count:0
Registration date
2019-04-17, 1398/01/28
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
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Citrus aurantium aroma on sexual function in menopausal women
Public title
Effect of Citrus aurantium aroma on sexual function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Insensitivity to Citrus aurantium and almond oil
Earn a score of less than 28 in the Sexual Function Questionnaire
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-occurrence of stressful incidents in the past six months
Have enough literacy to fill out a questionnaire
Non-use of drugs, tobacco and alcohol
Exclusion criteria:
the appearance of any physical and psychological illness during the study
Living away from the spouse and causing unexpected stressors (divorce, death and travel)
Incidence of side effects and sensitivity to essential oil during the study
Failure to run the program 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
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned blocks with 6 blocks to two groups of intervention and control group. The sampling will be done in a non-probabilistic manner, so that from the beginning of the study, all individuals who qualify for entry criteria and it does not have exit criteria will be selected as a sample, and this will continue until it reaches the final sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, to hide the allocation of aromas (essence of Citrus aurantium) and placebo (Almond oil) Opaque envelopes sequentially numbered are used.Each envelope contains a glass of essence of Citrus aurantium 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 80. 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
کمیته اخلاق دانشگاه علوم پزشکی جندی شاپور اهواز
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.AJUMS.REC.1398.020
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual function
Timepoint
Before and after the end of the intervention period
Method of measurement
Female Sexual Function Index
Secondary outcomes
1
Description
Complications
Timepoint
During the intervention
Method of measurement
Questionnaire made by the researcher
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% 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 at a concentration of 5% 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-z@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-z@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