determination of Elaeagnus angustifolia flower essential oil inhalation on the sexual function of women in reproductive age
Design
Clinical trial with control group, randomized, three groups
Settings and conduct
This study will be done on women referring to health centers and university hospitals (Imam Reza Hospital of Mashhad).Intervention group 1 is asked to mask 2-3 drops of essential oil three times a day for 4 weeks and inhale for 20 minutes each time. For intervention group 2, the same product should be prescribed 20 minutes before sexual intercourse.The control group received a pamphlet on sexual function at the end of the study.At the end of week 4, patients will be asked to come in person and the Female Sexual Function Index( FSFI) questionnaire will be completed.
Participants/Inclusion and exclusion criteria
Inclusion entrance: sexual function score(FSFI) less than 28؛ no olfactory disorder
Exclusion criteria:Sexual dysfunction in spouse؛ pregnancy and lactation؛ Drugs affecting sexual function by self or spouse؛ medical illnesses affecting sexual function in woman and her husband
Intervention groups
Intervention group:Intervention group 1 is asked to mask 2-3 drops of essential oil three times a day for 4 weeks and inhalation for 20 minutes each time. For intervention group 2, 2-3 drops of the same product should be prescribed 20 minutes before sexual intercourse.
Main outcome variables
Sexual Function Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191203045589N1
Registration date:2020-02-15, 1398/11/26
Registration timing:registered_while_recruiting
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Behnaz Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3712 0246
Email address
jafarib961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Elaeagnus angustifolia flower essential oil inhalation on the sexual function of women in reproductive age
Public title
Elaeagnus angustifolia flower essential oil on sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sexual function score less than 28
No disorder sense of smell
Exclusion criteria:
partner sexual dysfunction
Pregnancy and lactation
Taking drugs that affect one's sexuality by his or her husband
Known medical conditions affecting sexual function in a woman and her husband
common cold
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, will use a randomized blocking method, Using triple blocks (ABC (1) - ACB (2) - BAC (3) - BCA (4) - CAB (5) so that A first intervention group، B Second intervention group And C will be the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Biomedical Research of School of Nursing and Midwifery, Mashhad University of Me
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.071
Health conditions studied
1
Description of health condition studied
sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual Function Score
Timepoint
primary and fourth week
Method of measurement
Female sexual function index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People in this group were asked to pour 2-3 drops of essential oil on the mask for 4 weeks, three times a day, and inhale it every 20 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: People in this group are asked for 4 weeks 2-3 drops of essential oil 20 minutes before sexual intercourse on the mask and inhale for 20 minutes.
Category
Treatment - Drugs
3
Description
Control group: received a pamphlet on sexual function at the end of the study
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام رضا مشهد
Full name of responsible person
راحله بابازاده
Street address
School of Nursing and Midwifery, daneshgah street, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Bahraini
Street address
School of Nursing and Midwifery, daneshgah street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Email
jafarib961@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Babazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, daneshgah street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Babazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,daneshgah street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Behnaz jafari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, daneshgah street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3712 0246
Email
jafarib961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be shared after it is unrecognizable
When the data will become available and for how long
6 month after the results were recorded
To whom data/document is available
All researchers
Under which criteria data/document could be used
All women with sexual dysfunction
From where data/document is obtainable
Email jafarib961@mums.ac.ir
Mashhad School of Nursing Library
Address: Mashhad. daneshgah street
What processes are involved for a request to access data/document
First, she requested an email And if not responding up to one week can refer to Mashhad School of Nursing Library