It is a randomized, double-blind clinical trial with two groups of experimental and control. Population study is females of reproductive age in two 30-persons groups who referred to midwifery clinics in Mashhad. Researcher selects all women aged 15 to 45 years old who receive midwifery care from the chosen clinic (convenience sampling).
First, the researcher explains about the object of the study, implementation and the way of answering the questions. After obtaining consent from all subjects and ensure them to keep their information confidential, a pretest is taken. women who satisfy inclusion criteria and the score of their sexual function is less than 28 enter the study. Then they will be allocated to placebo and experimental groups randomly (30 persons in each group). For this reason, olive oil and Squill oil will be placed in a box (having code and similar together) and each matched-pairs picks up the medication herself, therefore the researcher is not aware of the oil type (double-blind). Then a training pamphlet will be given to the subjects explaining the way of using the oil, the anatomy of reproductive system and clitoris area in simple words and using pictures.
Subjects should use the oil for 4 weeks, 2 -3 drops of oil should be rubbed gently and roundly on clitoral area 5 minutes before having sex (sensitive organ located above the urethra).
According to the checklist prepared before, subjects will be followed up with phone call and their information including the number of having sex, the number of time they used oil, the amount of oil they used and its side effect will be recorded each weak. At the end of four weeks posttest will be taken from the subjects using the Female Sexual Function Index (FSFI) and sexual function of two groups before and after the intervention will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051033897N1
Registration date:2017-09-29, 1396/07/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-29, 1396/07/07
Registrant information
Name
Maryam Abbasi Pirooz
Name of organization / entity
Mashhad University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 6405
Email address
abbasipm941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2017-07-09, 1396/04/18
Expected recruitment end date
2017-08-09, 1396/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Squill oil on sexual function in females of reproductive age
Public title
sexual function in females of reproductive age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
15 to 45 years old; living with husband at least for 6 months; Be married and the only wife of her spouse; Lives with her spouse at the moment; The scores of Sexual function are less than 28
Exclusion criteria:
Pregnant or three months after delivery; Addiction to drugs or alcohol in any of couple; Research Unit or her husband has any disabilities; physical or scroll problem; The history of infertility
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Qualified samples are randomly divided into two groups of 30 by removing even or odd ball from the bag. Therefore, if the subject draw even ball, she receives box A, otherwise she receives box B. Oils have similar appearance and they are placed into similar boxes by Pharmacist. Only after the end of the study, the name and characteristic of the subject that is written on the box will be revealed
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, Daneshgah St
City
Mashhad
Postal code
9137913199
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.MUMS.REC.1396.64
Health conditions studied
1
Description of health condition studied
Function sexual
ICD-10 code
F59.2
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
sexual function
Timepoint
Before intervention,4 weeks after of treatment
Method of measurement
sexual function questionnaire(FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: squill oil should be rubbed the clitoris region for 2 to 3 drops 5 minues be fore sex
Category
Placebo
2
Description
control group: olive oil should be rubbed in to the clitoris region for 2 to 3 drops 5 minutes before sex
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Efat koohjani
Street address
Ahmadabad st
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Kazem Shabani
Street address
Ebnesina st
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, Daneshgah St
City
Mashhad
Grant name
الف
Grant code / Reference number
951643
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Maryam Abbasi Pirooz
Position
Masters of Midiwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
91778774896
Phone
+98 518796405
Fax
Email
abbasipm941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
khadije Mirzaii
Position
PhD of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
9138813944
Phone
+98 51 3841 3008
Fax
+98 38413006
Email
mirzaiikh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Maryam Abbasi Pirooz
Position
Master of health Fertility
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
9177874896
Phone
+98 51 3879 6405
Fax
Email
abbasipm941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)