the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure

Phase 3

• Conditions: nipple fissure.; Fissure and fistula of nipple

• Registration Number: IRCT2015080723535N1
• Lead Sponsor: research and technology department of Shahid Beheshti University of Medical Sciences, Tehran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 100

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Improvement of nipple fissure. Timepoint: before intervention, day 3 and day 7 after intervention. Method of measurement: Storr scale to measure nipple fissure.

Secondary Outcome Measures

Name	Time	Method
Side effects of Pistacia Atlantica ointment. Timepoint: before intervention, day 3 and day 7 after intervention. Method of measurement: examining and interviewing the patient.