1. Home
  2. Approved trials
  3. » فارسی

Investigation of The effectiveness of auriculotherapy on sexual function of women of reproductive age to comprehensive health centers in Baft city at the year 1399-1400

Protocol summary

Study aim
The effect of auriculotherapy on sexual function in women of reproductive age
Design
A control trial with a control group, with parallel groups, one-way blind, randomized, was used to randomize the rand function of Excel software.
Settings and conduct
Preliminary sampling was easy or available, all women of reproductive age were referred to the comprehensive health centers of Baft city and then randomization was performed and participants were blinded and statistical evaluation was performed.
Participants/Inclusion and exclusion criteria
Having at least one healthy ear, having at least one sexual problem, no vaginal or cervical infection, no patient cooperating in squeezing the sides
Intervention groups
Intervention group: 10 sessions per week, in each session after disinfection and ear massage, impotence and decreased libido from the left ear including sexual dysfunction, genitalia, gonadotropin, ovary, zero point, my sand, endocrine, master Cerebral, anxiety point, thalamic. Excessive libido on the right ear is aroused by sexual complication, irritability point, excitement point, ovary, zero point, my sand, tranquilizer point, thalamic. At the end of each session, the plant seeds are placed in the designated places and stored for at least 3 days. Control group: Massage parts of the ear by hand.
Main outcome variables
Auriculotherapy affects the sexual function of women of childbearing age.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191130045549N2
Registration date: 2022-12-03, 1401/09/12
Registration timing: retrospective

Last update: 2022-12-03, 1401/09/12
Update count: 0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Omolbanin Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4244 1785
Email address
heydari201203@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of The effectiveness of auriculotherapy on sexual function of women of reproductive age to comprehensive health centers in Baft city at the year 1399-1400
Public title
investigation of The effectiveness of auriculotherapy on sexual function of women of reproductive age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 45 be sexually active have no history of physical or mental illness or depression have no history of antidepressant use, sedatives no infection or scarring on the outer ear have a minimum of literacy and numeracy Have at least one healthy ear have at least one sexual problem no vaginal or cervical infection
Exclusion criteria:
Lack of patient cooperation on pressing the inserted sidewalls Severe marital conflicts The occurrence of a tragic event (death of loved ones, etc.)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
60 women of childbearing age will be selected easily (available) and for random allocation, 4 and 8 blocks with a 1: 1 allocation ratio will be used. After listing almost all possible modes of blocks 4 and 8 and assigning a number to each of them using the site www.Randomizer.org will be selected as an allocation sequence, so that the total number of samples is 60 People became. Then, to hide the Allocation Concealment, the type of intervention numbered on the first 30 cards of number 1, the second 30 cards of number 2, will be written on paper and placed in a series of sealed envelopes. Number 1 of the auricular therapy group will be number 2 of the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be placed in the Syed intervention group and small adhesives without Vacaria will be placed in the control group. Outcome assessors and data analysts have no knowledge of intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
no

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.KMU.REC.1399.73

Health conditions studied

1

Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of sexual function disorders in the sexual function questionnaire
Timepoint
Measurement of sexual function disorders before and after the intervention
Method of measurement
Female Sexual Function questionnaire

2

Description
Sexual satisfaction score in Larson's sexual satisfaction questionnaire
Timepoint
Measuring the sexual satisfaction of the patient and the patient's wife before and after the intervention
Method of measurement
Larson sexual satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Auriculotherapy group in ten sessions for 20 minutes using Vacaria plant seeds and handmade props made in China for erectile dysfunction and decreased libido from the left ear points including sexual dysfunction, genitalia, gonadotropin, ovary, zero point, Shen Man, endocrine Mr. Cerebral, anxiety point, thalamic, excessive libido on the right ear, sexual complicity, irritability point, excitement point, ovary, zero point, my sand, tranquilizer point, thalamic are stimulated. The seeds should be taken every hour during the day. Stimulated for one minute by the patient for three days.
Category
Treatment - Devices

2

Description
Control group: They massage parts of the ear with their hands
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baft comprehensive health centers
Full name of responsible person
Dr. Masoumeh Ghazanfarpour
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Baft
Province
Kerman
Postal code
7616913555
Phone
+98 913 633 0656
Email
masumeh.ghazanfarpour@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Ghazanfarpour
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
masumeh.ghazanfarpour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
30
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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Ghazanfarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
masumeh.ghazanfarpour@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Ghazanfarpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
masumeh.ghazanfarpour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omolbanin Heydari
Position
Employee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
khatam Anbia Baft Hospital
City
Baft
Province
Kerman
Postal code
781949443
Phone
+98 34 4244 1785
Fax
Email
heydari201203@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Data will be provided to all applicants.
Under which criteria data/document could be used
Any kind of analysis on the data is allowed.
From where data/document is obtainable
Through the following email, which belongs to Dr. Masoumeh Ghazanfarpour:masumeh.ghazanfarpour@yahoo.com
What processes are involved for a request to access data/document
Through correspondence and e-mail with Dr. Masoumeh Ghazanfarpour and if 6 months have passed since the publication of the results.
Comments
Loading...