Investigating the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure among visited breast feeding women in health centers of Shahid Beheshti university of Sciences in 1394
The aim of this randomized clinical trial is to investigate the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure among visited breast feeding women in health centers of Shahid Beheshti University of Sciences. In this study, women suffering from nipple fissure and nipple pain who exclusively breast fed and get at least grade 3 through Storr scale; have healthy term infants; normal infant weight and without any mouth or palate or jaw or face anomaly; mother without any nipple malformation are entered to this study. Excluding criteria include the infant usage of a pacifier or feeding bottle; the infant gets infected to a disease; the mother makes use of milking machine or plastic nipple; the mother gets infected to mastitis, breast abscesses or fungal infection of the breast and use of the proposed treatment less than three times a day. 100 sample will be assigned randomly into two groups: applying Pistacia Atlantica ointment or control group (expressed breast milk). In the intervention group mothers apply an amount of Pistacia Atlantica ointment on nipple and Areola after feeding three times a day for 7 days. Mothers in control group apply 3-4 drops of their breast milk on nipple and areola after each feeding for 7 days and allow the nipples to air dry. At the begining two groups will receive correct feeding technique. Storr scale and Numerical Rating Scale is completed before the study, on day 3 and on day 7 after the study by the investigator to evaluate nipple fissure and nipple pain intensity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080723535N1
Registration date:2015-11-24, 1394/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-24, 1394/09/03
Registrant information
Name
Nayereh Asadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
asadi-nayereh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
research and technology department of Shahid Beheshti University of Medical Sciences, Tehran
Expected recruitment start date
2015-08-17, 1394/05/26
Expected recruitment end date
2015-12-18, 1394/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure among visited breast feeding women in health centers of Shahid Beheshti university of Sciences in 1394
Public title
the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria: Mothers suffering from nipple pain and nipple fissure who; get at least grade 3 through Storr scale; more than 18 years old; Iranian and live in Tehran; literate; singleton birth; term and healthy infant and exclusively breast fed; infant weight 2500 to 4000 grams; infant without any mouth or palate or jaw or face anomaly; mother without any identified mental disease; mother without any nipple malformation (flat or inverted nipples or any nipple malformation which is followed by burning or any history of nipple and areola operation in childhood); mothers don't suffer from known background diseases such as diabetes or any kind of internal_surgical diseases; mothers who do not have any allergy to Pistacia Atlantica ointment.
Excluding Criteria: During the study, the infant uses a pacifier or feeding bottle;The mother makes use of milking machine or plastic nipple; During the study, the infant gets infected to a disease; During the study, allergy to Pistacia Atlantica occurs; During the study the mother uses antibiotic;The mother gets infected to mastitis, breast abscesses or fungal infection of the breast; The mother does not desire to continue cooperation; Use of the proposed treatment less than three times a day; Use of the other treatments by the mother.
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Institutional Ethics Committee of the Faculty of Pharmacy and Nursing Midwifery of Shahid Beheshti U
Street address
Vali-Asr Avenue, Cross of Vali-Asr and Niayesh Highway, opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2015-07-21, 1394/04/30
Ethics committee reference number
SBMU2.REC.1394.10
Health conditions studied
1
Description of health condition studied
nipple fissure
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
reduction of nipple pain
Timepoint
before intervention, day 3 and day 7 after intervention
Method of measurement
using Numerical Rating Scale for measuring pain intensity
2
Description
improvement of nipple fissure
Timepoint
before intervention, day 3 and day 7 after intervention
Method of measurement
Storr scale to measure nipple fissure
Secondary outcomes
1
Description
side effects of Pistacia Atlantica ointment
Timepoint
before intervention, day 3 and day 7 after intervention
Method of measurement
examining and interviewing the patient
Intervention groups
1
Description
1 gram of Pistacia Atlantica ointment (in 24 gram cans) will be rubbed to the nipple and areola three times a day for 7 days.
Category
Treatment - Drugs
2
Description
In the control group 2-3 drops of expressed breast milk will be rubbed to the nipple and areola after each feeding and then allow to air dry for seven days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Sciences, health center of the North of Tehran (Nader)
Full name of responsible person
Nayereh Asadi
Street address
NO. 57, Shahid Esfandany street, Jashnvareh street, second square of Tehranpars, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Shahid Beheshti University of Sciences, health center of the North of Tehran (Samarghandi)
Full name of responsible person
Nayereh Asadi
Street address
No. 175, between 206 and 212 street, Ordibehesht square, Farjam street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research and technology department of Shahid Beheshti University of Medical Sciences, Tehran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research and technology department of Shahid Beheshti University of Medical Sciences, Tehran
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
Shahid Beheshti University of Sciences, Tehran
Full name of responsible person
Nayereh Asadi
Position
Master of Science university student of Midwifery
Other areas of specialty/work
Street address
Tehran - Shahid Chamran Highway Yemen street , A'rabi Street, near Shahid Ayatollah Taleghani hospital,Shahid Beheshti University of Medical Sciences, Tehran