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The effect of Auriculotherapy on Lactation of Women who underwent Caesarean sections

Protocol summary

Study aim
To determine the effect of Ear Acupuncture on lactation of women who underwent caesarean sections
Design
One-blind sham controlled clinical trial with a parallel group design of 86 patients, randomized by Excel software into two groups
Settings and conduct
Sampling will perform in 2 selected Hospitals in Rafsanjan. Participants will meet criteria for Insufficient breastfeeding. They will then randomly divided into two groups of 43 people. Infant weight, breast volume and maternal serum prolactin level will measured before and then after the research. The intervention group receives acupressure of Ear by Vakaria seed on the dominant auricular points that include Prolactin, Endocrine, Small intestine1, Shen men and Liver for three times a day and one minute each time during ten days and recessive ear points that include Mammary gland, Kidney and Sympathetic autonomic points receives acupressure with same method. sham control group will receives label without Vakaria seeds in same points with out any stimulation, so the participant will be blind to the type of treatment. On the tenth day of the intervention Sufficient breastfeeding, Uterine recovery Will be checked.
Participants/Inclusion and exclusion criteria
Age between 18 and 38 years, Gestational age between 37 and 42 weeks, Single fetus, Meet objective and perceived criteria for inadequate breastfeeding in the morning of the first day after cesarean section, Normal BMI, No known chronic systemic diseases, lack of breast problems, no taking any drugs interfering milk production and any methods for increasing lactation, Lack of adverse outcomes for infants and mothers
Intervention groups
Intervention group receives acupressure of Ear by Vakaria seed , Sham control group will receives label without Vakaria seeds
Main outcome variables
Infant weight, breast volume, serum prolactin level, Sufficient breastfeeding, Uterine recovery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201020049086N1
Registration date: 2021-06-19, 1400/03/29
Registration timing: prospective

Last update: 2021-06-19, 1400/03/29
Update count: 0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Fatemeh Khorasanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3421 5205
Email address
khorasanian.f@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-24, 1400/04/03
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auriculotherapy on Lactation of Women who underwent Caesarean sections
Public title
The effect of Ear acupressure on lactation of women who underwent caesarean sections
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of 37-42 weeks Has objective and perceived criteria for breastfeeding inadequacy according to the checklist The mother has a normal body mass index (19.8-26 kg / m 2) Having the ability to write and read Live single fetus Baby weighing between 2.5 and 4 kg The infant has no low Apgar score, jaundice and congenital malformations The infants should have sucking and routing reflexes and complete neural development The mother should not have chorioamnionitis, preeclampsia and diabetes in the current pregnancy Mothers should not be addicted to drugs, psychotropic drugs or alcohol Mothers should not have Untreated Active Tuberculosis or Immunodeficiency Virus No known medical conditions such as Chronic systemic diseases and advanced cancer The woman should not have breast problems such as abscesses, nipple dislocations, and low or non-glandular tissue of the breast Mothers should not have ear piercings in the areas intended for acupressure
Exclusion criteria:
Lack of desire of mothers to continue to participate in research Failure to perform acupressure as taught in three consecutive times The mother stops breastfeeding for any reason Signs of infection, bleeding, shock and convulsions after delivery Infant hospitalization in neonatal intensive care unit Use other methods to increase breastfeeding Any physical and mental illness that disrupts breastfeeding, such as liver disease, cancer, mammalian problems and Postpartum depression
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method, using an Excel spreadsheet. In the Excel spreadsheet the leftmost column shows the total number of participants, which in the current study will be 86. First we arrange the random numbers then in ascending order. The next column indicates the group to which participants belong, with the top half in Group A and the bottom half in Group B. For the next column is filled using the" Rand "function; this function generates random numbers for all individuals, so the individuals will be randomly ordered within each of the two groups. At the end they enter the study according to the order of referral and allocate a code to them. Random unit: individual Randomization Tool: Software
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, sham control group will be matched with ear acupressure group in terms of all confounding variables but the type of label used in sham control group will be without Vakaria seeds and the mother will not stimulate the points. In this way, the participant and data Analyzer will not know how the groups are assigned. For this purpose, a complete explanation of the interventions will be given to the participant before random allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Ethics Committee of the Faculty of Pharmacy and Nursing Midwifery of Shahid Beheshti U
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.012

Health conditions studied

1

Description of health condition studied
Breastfeeding
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maternal serum Prolactin
Timepoint
At the beginning of the study (before the intervention) and Tenth day after cesarean delivery (end of the study)
Method of measurement
Prolactin Laboratory Kit

2

Description
Baby weight gain
Timepoint
At the beginning of the study (before the intervention) and Tenth day after cesarean delivery (end of the study)
Method of measurement
Digital scales for children

3

Description
Breast volume
Timepoint
At the beginning of the study (before the intervention) and Tenth day after cesarean delivery (end of the intervention)
Method of measurement
Height and radius of the breast will be measured by Caliper and placed in the volume formula

4

Description
Sufficient breastfeeding
Timepoint
Tenth day after cesarean delivery(end of the intervention)
Method of measurement
Sufficient breastfeeding questionnaire

5

Description
Uterine recovery
Timepoint
Tenth day after cesarean delivery(end of the intervention)
Method of measurement
Touch Uterine fundus from the abdomen

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group receives acupressure of Ear by Vakaria seed on the dominant auricular points that include Prolactin, Endocrine, Small intestine1, Shen men and Liver for three times a day and one minute each time during ten days and recessive ear points that include Mammary gland, Kidney and Sympathetic autonomic points receives acupressure with same method in dominant ear. The above points will be identified by the researcher and using the Pointer Excel 2 device.
Category
Treatment - Devices

2

Description
The sham control group receives the intervention by application of label without Vakaria seeds and any stimulation in the same areas of the acupressure intervention group.The above points will be identified by the researcher and using the Pointer Excel 2 device.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Niknafs Maternity
Full name of responsible person
Maryam Mirmotalebi
Street address
Niknfs Hospital, Shohada Street, Rafsajan
City
Rafsanjan
Province
Kerman
Postal code
7713961159
Phone
+98 34 3425 9030
Fax
+98 34 3426 9380
Email
niknafs@rums.ac.ir
Web page address
http://niknafs.rums.ac.ir

2

Recruitment center
Name of recruitment center
Hazrat Ali Ibn Abi Talib Hospital
Full name of responsible person
Ali Mousavi
Street address
Hazrat Ali Ibn Abi Talib Hospital, Moftah Boulevard, Rafsanjan, kerman, iran
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0022
Fax
+98 34 3428 0022
Email
aliebn_hospital@rums.ac.ir
Web page address
http://aliebn.rums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Khorasanian
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
First House on the left, 9th Alley, South Meraj Street
City
Rafsanjan
Province
Kerman
Postal code
7719656799
Phone
+98 34 3421 5205
Email
Khorasanian.fatemeh7727@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences , Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0098 21 888202512
Email
msimbar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Khorasanian
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
First House on the left, 9th Alley, South Meraj Street
City
Rafsanjan
Province
Kerman
Postal code
7719656799
Phone
+98 34 3421 5205
Email
Khorasanian.fatemeh7727@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Protocol and data files
When the data will become available and for how long
After publishing the article
To whom data/document is available
For Journal reviewers and the readers of the article if they need
Under which criteria data/document could be used
If they asked
From where data/document is obtainable
Midwifery and Reproductive Health Rese4arch Center Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
email to researchers
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