Determining the effect of ear acupressure on the sexual function of lactating women referring to Qazvin comprehensive health centers in 1398
Design
A randomized controlled clinical trial.
Settings and conduct
1- Obtaining the permission of the Ethics Committee and the clinical trial code after the approval of the proposal, Obtaining the necessary letters for attending the centers (Qazvin Health Centers).2-After obtaining written consent and obtaining permission, samples will be registered for inclusion in the study.3-a simple random blocking method with 4 blocks will be used to randomize the sample. Research participants will be randomly divided into two groups of intervention (Acupressure) and control group (without intervention).4-The demographic-midwifery and female sexual function index (FSFI) questionnaire will be completed before the intervention by the participants and in the presence of the researcher.5-The intervention (Acupressure) will be performed.6-Sexual Function Evaluation in both intervention and control groups using the FSFI questionnaire will be performed immediately one and two months after the end of the intervention.A call will be made to remind the completion of the questionnaires.7-Analysis: After the end of the data gathering, the analysis of the findings will be done.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Being Primiparous, Having Lactation, Having a Baby from Term and Single Delivery, Being in the First Year after Childbirth
Exclusion Criteria: The presence of complications in pregnancy and postpartum,substance abuse in a person or her husband, history of diseases and the use of drugs that affect sexual function
Intervention groups
1-Ear Acupressure 2-Control with routine care
Main outcome variables
Sexual Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190626044028N1
Registration date:2019-08-16, 1398/05/25
Registration timing:prospective
Last update:2019-08-16, 1398/05/25
Update count:0
Registration date
2019-08-16, 1398/05/25
Registrant information
Name
Sanaz Barghamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7713 4704
Email address
s.barghamadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Auricular Acupressure on Lactating Women’s Sexual Function
Public title
The Effect of Auricular Acupressure on Lactating Women’s Sexual Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Desire to Participate in the Study
Being Primipara
Having Lactation
Having term and singleton Baby
Being in the First Year after Childbirth
Having a Natural Auricle Without Lesion, Wounds and Pain on the Auricle
Being Iranian
Ability to read and write
Availability During the Study Period
Exclusion criteria:
Being Away from the Spouse
Polygamous Husband
Complications in Pregnancy and Postpartum
The History of Mental and Physical Illness (Self-Declaration and Examination of a Person's Health Record)
Postpartum Depression detected by the Edinburgh Postnatal Depression Scale
Substance Abuse in the Person or her Husband
A History of Using Acupressure in the Last Three Months
A History of Diseases Affecting the Sexual Function of a Woman or her Husband such as Premature Ejaculation, Cardiovascular, Psychiatric, Thyroid Disease and All Types of Cancers and Genital Trauma
Use of Drugs That Affect Sexual Function Such as Psychoactive, Cardiovascular, Nervous and Hormonal Drugs
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
participants will be randomized into two groups by the Simple Random Blocking method with 4 blocks.In the block randomization method, the assigning sequence will be written before the commencement of the research. Given that two groups will be studied, four blocks will be used and one letter will be assigned to one group (A: EMDR group; B: control group). All possible modes of the 4 blocks will be written and numbered. So, in each block, two participants will be assigned to the intervention group and two will be assigned to the control group. Then, using a simple random method and the table of random numbers, a number of blocks will be selected from the blocks of numbers. By writing the contents of the blocks for those numbers (as long as the sample size is determined), the sequence of random allocation is determined.
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 Qazvin University of Medical Sciences
Street address
Qazvin university of medical science, Bahonar Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.QUMS.REC.1398.056
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
Timepoint
Sexual Function Measurement at the beginning of the study (before intervention) ,immidiate, 1 and 2 months after intervention
Method of measurement
Sexual Function Score in Female Sexual Function Index
Secondary outcomes
1
Description
sexual quality of life
Timepoint
before, 1 and 2 month after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: acupressure group: The trained researcher first cleaned both auricle with 75% alcohol and then sticks the vaccaria seeds with non-latex adhesives tape on the 5th point of the ear (genital points (two points), Pelvic point, Master Soulder and posterior hypophysis) that affects the sexual function of the person. A total of 10 sessions are held at intervals of four days per person. During these sessions, the seeds are stuck on the points and the subject is trained to hold the seeds for three days on her ear and during this time she should press each of the points three times a day for twenty Seconds. The pressure technique should be such that the person performs a moderate instillation by pressing firmly and a little tighter, until she feels a tingling and mild discomfort. After three days, the person can remove the seeds from her ear and rest one day. The number of pressing will be reminded to the subject via SMS daily. she will also be reminded by phone call that the fifth day will be referred to the center for resticking the new vaccaria seeds. This procedure takes place in ten sessions for each subject. It should be noted that if the subject experienced any problem during the use of the method for any reason (the movement of seeds, removing them, etc.) could separate the previous seeds and request the researcher to restick the new seeds again.
Category
Treatment - Devices
2
Description
Control group: Receive Counseling and routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Health center
Full name of responsible person
Sanaz Barghamadi
Street address
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6003
Email
sanaz_barghamadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Qazvin university of medical science, Bahonar Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6003
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Web page address
http://qums.ac.ir/Portal/Home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Sanaz Barghamadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin university of medical science, Bahonar Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 21 7713 4704
Fax
Email
s.barghamadi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sanaz Barghamadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin university of medical science, Bahonar Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 21 7713 4704
Fax
Email
s.barghamadi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sanaz Barghamadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin university of medical science, Bahonar Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 21 7713 4704
Fax
Email
s.barghamadi@qums.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
Information about the original outcome is shared
When the data will become available and for how long
Start of the 6 month period after the publication of the study results
To whom data/document is available
All researchers in the field of health sciences and medicine can apply for data.
Under which criteria data/document could be used
A new analysis of data can be done only by explaining the reasons for the request for such an analysis and with the knowledge of the researcher
From where data/document is obtainable
To receive the data, you can contact the person responsible for this clinical practice (Sanaz Borgamadi) by e-mail s.barghamadi@qums.ac.ir.
What processes are involved for a request to access data/document
fter receiving the application for having a data file and obtaining permission from the university Research Deputy, the data file is shared.