The effect of increased clitoral blood flow via radio frequency wave on libido in women with decreased libido
Design
Forty-six married women with decreased libido who meet the inclusion criteria are randomly divided into intervention and control groups.
Settings and conduct
This study is performed in Farshchian Hospital in Hamadan. Intervention group: Up to three times every ten days, they use monoplar RF tools with both warm-up techniques and high-power endo gym in the vagina.
In the control group, monoplar RF instruments are used up to three times every ten days using the low power endo gym technique without heating in the vagin
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married and have at least 6 months of continuous sexual relationship with a partner-No childbirth in the last 12 months- No breastfeeding in the last three months-Negative pregnancy test.
Exclusion criteria: erectile dysfunction or other obvious sexual disorders in the patient's spouse - use of drugs that cause sexual disorders - concomitant medical illness - substance abuse
Intervention groups
Intervention group: Up to three times every ten days, they use monoplar RF tools with both warm-up techniques and high-power endo gym in the vagina.
Control group: Up to three times every ten days of monoplar RF instrument using low power endo gym technique without heating in the vagina.
Main outcome variables
Marital Satisfaction - Depression and Women's Sexual Desire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N6
Registration date:2021-01-05, 1399/10/16
Registration timing:registered_while_recruiting
Last update:2021-01-05, 1399/10/16
Update count:0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
1960-12-22, 1339/10/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of increased clitoral blood flow on libido in women with decreased libido
Public title
Effect of increased clitoral blood flow on libido
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married and have at least 6 months of continuous sexual relationship with a partner
No childbirth in the last 12 months
No breastfeeding in the last three months
Negative pregnancy test
Exclusion criteria:
Erectile dysfunction or other obvious sexual disorders in the patient's spouse
Taking drugs that cause sexual disorders
Simultaneous medical illness
Substance abuse
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
56
More than 1 sample in each individual
Number of samples in each individual:
23
Number of samples in each individual: 23
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to the intervention and control groups using block randomization The patients will be randomly assigned to the intervention and control groups using block randomization Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number (between 1 and 6 ) to each of them 3)Choosing random numbers between 1 and 6 4) Defining the treatment assignment list
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the examining physician will not be aware of the patient's type of drug treatment, so the study will be performed in a double-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
1960-12-20, 1339/09/29
Ethics committee reference number
IR.UMSHA.REC.1399.784
Health conditions studied
1
Description of health condition studied
Lack or loss of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
female sexual desire
Timepoint
At the start of intervention- After intervention
Method of measurement
Using the Female Sexual Function Index questionnaire
2
Description
Marital satisfaction
Timepoint
At the start of intervention- After intervention
Method of measurement
Using the Enriching and Nurturing Relationship Issues, Communication and Happiness(ENRICH) questionnaire
3
Description
Depression rate
Timepoint
At the start of intervention- After intervention
Method of measurement
Hamilton Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Up to three times every ten days of monoplar RF instrument using low power endo gym technique without heating in the vagina.
Category
Treatment - Devices
2
Description
Intervention group: Up to three times every ten days, they use monoplar RF tools with both warm-up techniques and high-power endo gym in the vagina.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Haghighi
Street address
honarestan Str.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
haghighi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
haghighi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
haghighi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
honarestan Str.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
haghighi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
haghighi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD