The effect of Auriculotherapy on the function and quality of life on lactating primipara women
Design
A single-blind parallel-controlled clinical trial with two groups of control and intervention
Settings and conduct
Centers and Comprehensive Health Service Centers of Qom. In the intervention group are accomplishedAuriculotherapy. In the control group, all stages are arranged artificially and the Shem method is used for the blindness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: lactating primipara women aged 18 to 45 years old in the period of 6 weeks to 6 months after childbirth
Exclusion criteria: pregnancy, dead of the infant during the study and being away from the spouse
Intervention groups
In the intervention group: using an Excel 2 device on the special points of the right ear including, Shen men points, zero points, thalamic points, vertebral and ovary points, endocrine point, external genitalia or libido, and Relax points), electrical stimulation with frequency 5 Hertz and every 15 seconds. Then three points are selected and cached. The sessions are 3 days a total of 5 weeks and 10 sessions. In the control group, we turn off the device and do not press it on the points. We seize the Vaccaria on non-specific points.
Main outcome variables
Sexual function of women, Quality of women's sexual life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038302N5
Registration date:2019-06-08, 1398/03/18
Registration timing:registered_while_recruiting
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Mansoureh Yazdkhasti
Name of organization / entity
Alborz University medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 8856
Email address
m.yazdkhasti@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-14, 1398/01/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auriculotherapy on sexual function and sexual quality of life in primiparus lactating women
Public title
The effect of Auriculotherapy on sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
single - term delivery
Pass 6 weeks to 6 months of delivery
The number of Edinburgh questionnaires (postpartum depression) is less than 13
18 to 45 years old
Having a healthy eardrum for Auriculotherapy
Exclusively breastfeeding
Exclusion criteria:
Pregnancy during study
Loss of infant during study
Being away from the spouse
Hearing problems (tinnitus, ear infections, or otitis media).
Having underlying physical illnesses (blood pressure, diabetes, and seizures in the participant or her spouse's)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Balance Randomization 4th is accomplished with software. In this method size of the whole Blocks are equal. In this study with 60 sample size, a number of blocks are 15 and the size of each block is 4 and there are 6 modes. The number of people in the control and intervention group is the same(30 people in each group).
Blinding (investigator's opinion)
Single blinded
Blinding description
In the control group, all stages are arranged and the Shem method is used for blindness. In this way, we turn off the device and do not put pressure on the points. And Seyyed Vakaria is tied to non-specific points. It should be noted that in order to avoid interference of the samples, in pairs for the clients in the group of monitors Auriculotherapy will be performed on the days of the person assigned to the patients in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Plaque 142,Boali street, Nabovat blvd, Karaj city , Iran
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
IR.ABZUMS.REC.1397.181
Health conditions studied
1
Description of health condition studied
Sexual function - Quality of sexual life
ICD-10 code
F66
ICD-10 code description
Other sexual dysfunction
Primary outcomes
1
Description
Female sexual function
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
MSISQ-19
2
Description
Women's sexual Quality of Life
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
Women's Quality of Life Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Auriculotherapy for Lactating primipara women eligible for study, for 10 sessions a week, 2 times for 5 weeks
Category
Treatment - Other
2
Description
Control group: Auriculotherapy for lactating primipara women who are eligible to participate in the study, which is done for 5 weeks, twice a week for 10 sessions with a silent work machine.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Qom city
Full name of responsible person
Mansoureh Yazdkhshati
Street address
Plaque 16, ,Beheshti st, Health center, Qom city , Iran
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 25 3660 0017
Email
Mansoyazd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ََAlborz University of Medical Sciences
Full name of responsible person
Mansoureh Yazdkhshati
Street address
Plaque 130, Taleqani Blvd, Taleqani Square, Karaj city, Iran
City
karaj
Province
Alborz
Postal code
1829346253
Phone
+98 26 4720 3433
Email
Mansoyazd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ََAlborz 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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Yazdkhshati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Plaque 130, Taleqani Blvd, Taleqani Square, Karaj city, Iran
City
karaj
Province
Alborz
Postal code
14125685
Phone
+98 2632558920_4
Email
Mansoyazd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of medical sciences
Full name of responsible person
Mansoreh Yazdkhasti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Plaque 130, Taleqani Blvd, Taleqani Square, Karaj city, Iran
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 2632558920_4
Email
Mansoyazd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University Medical Sciences
Full name of responsible person
Masoumeh Rashidi Ahmadabadi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Plaque 130, Taleqani Blvd, Taleqani Square, Karaj city, Iran
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 2632558920_4
Email
rouyeshmama@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available