Protocol summary

Summary
This study compared the effectiveness of acupressure (jianjing point) and compresses (hot and cold) on engorgement in lactating wemen . This clinical study on 70 cases of lactating wemen were referred to clinic of quem hospital, Firuz Abad in Fars.Inclusion criteria included lactating wemen with breast engorgement that did not have chronic and heart diseasis,sore nipple, breast abscess, fracture shoulder region, the history of traditional and herbal medicine to reduce breast engorgement.Exclusion criteria included wemen had tempreture over 38c during the treatment process.Samples, 35 person in Group compresses (hot and cold) or control gruop and 35 person in the acupressure group (Jyanjyng point) or intervention gruop were randomized. Treatment for each case in each group was 4 times,(2 times in first day and 2 times for second day for two consecutive days).Intensity of breast engorgement, befor and after treatment procedures, were measuremented and recorded in related to breast engorgement of chek list.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204065698N3
Registration date: 2012-06-06, 1391/03/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-06, 1391/03/17
Registrant information
Name
Mahbobeh Ahmadi
Name of organization / entity
Shahid Beheshti University of Medical & Health Service
Country
Iran (Islamic Republic of)
Phone
+98 21 7747 5651
Email address
mah.ahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University Of Medical Science
Expected recruitment start date
2009-12-11, 1388/09/20
Expected recruitment end date
2010-07-26, 1389/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of acupressure(jianjing point) and compress(hot and cold) on breast engorgement in lactating wemen
Public title
The effect of acupressure on breast engorgement
Purpose
Treatment
Inclusion/Exclusion criteria
Lactating wemen that had breast engorgement with a minimum score of breast congestion(2) due to inflammation of the breast skin, breast tension and breast pain; Mothers stop breast-feeding of drugs used are not using; Not with mothers who did not have suffering from breast abscess: Mothers who had high temperature 38 degrees Celsius; Mothers who did not have suffering from sore nipples or breast fissures; Mothers who had breast surgery; Mothers with a history of use in traditional herbal therapies and did not have to treat breast congestion; Mothers who had no contraindications to perform acupressure. (did not have heart disease and chronic) ; Mothers who suffered musculoskeletal injuries and joint pain to the shoulder with a massage Jyanjyng point, they may. Exclusion criteria were: mothers who had on the second day of fever over 38 ° c; mothers that did not like to continiue this searching
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Beheshti University Of Medical Science
Street address
Velenjak Street
City
Tehran
Postal code
Approval date
2010-10-24, 1389/08/02
Ethics committee reference number
پ/25/12/6188

Health conditions studied

1

Description of health condition studied
Breast engorgement
ICD-10 code
092.2
ICD-10 code description
Other and unspecified disorders of breast associated with childbirth

Primary outcomes

1

Description
Breast engorgement
Timepoint
Before intervention,After intervention
Method of measurement
Qustioner,List of score of engogement,Pain ruler

Secondary outcomes

1

Description
no
Timepoint
no
Method of measurement
no

Intervention groups

1

Description
Intervention group(accupresser): researcher the first,found the jainjing point and had massage with timb of her hands with parallel position for 2 min, then 30 seconds rest was given. This action simultaneously for both breast and took 20 minutes and then the rate of breast congestion, measured by the researcher and lists were in cheklist.For the second stage on the first day time was reserved. After mother cameback,researcher did intervention such as first period , and breastengorgement was recorded . For the second day, time was reserved..Accupresser had done for 4 times for any mother ,2 times in first day and 2 times in second day.
Category
Other

2

Description
Group treated with cold compresses and hot (control group): First, breast congestion intensity was measured and recorded in the chek list.then both of breast with parallel time, first hot compress done with 43-46 centigrade for 2 min and then cold compress with 10-18 centigrad for 2 min untile 20 min. Engorgement breast, by the researcher,messuerd and recorded. and then mother rested for 30 min.Before the start of second tretment,first,messured index of breastengorgement by reasercher and recorded. the next day, was given. The second day of treatment, fully in accordance with the first day of treatment, the treatment period to compress (hot and cold), 4 times, 2 times and 2 times the first day was on the second day.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem firoozabad hospital
Full name of responsible person
MaliheKamalimoradzade
Street address
Qaem firoozabad hospital
City
Firoozabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University Of Medical Science
Full name of responsible person
Mahboobe Ahmadi
Street address
Kiana Bilding, Shahid Babaii Street, Modares Buolvard
City
Shiraz
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 Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Nursing and Midwifery College Of Shahid Beheshti Of Medical Science
Full name of responsible person
Mahboobe Ahmadi
Position
Proffisore Of University
Other areas of specialty/work
Street address
Kiana Bilding, Shahid Babaii Street, Modares Buolvard
City
Shiraz
Postal code
7155764685
Phone
+98 71 1725 8514
Fax
Email
mah.1372@yahoo.commalihe_kamali@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mahboobe Ahmadi
Position
MA of Midwifery
Other areas of specialty/work
Street address
Kiana Bilding, Shahid Babaii Street, Modares Buolvard
City
Shiraz
Postal code
7155764685
Phone
+98 71 1725 8514
Fax
Email
mah.1372@yahoo.commalihe_kamali@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti college OF Midwifery and Nursing
Full name of responsible person
Mahboobe Ahmadi
Position
MA of Midwifery
Other areas of specialty/work
Street address
Kiana Bilding, Shahid Babaii Street, Modares Buolvard
City
Shiraz
Postal code
7155764685
Phone
+98 71 1725 8514
Fax
Email
mah.1372@yahoo.commalihe_kamali@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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