Clinical trial NCT01723995: Laser Therapy in Nipples Injured During Breastfeeding
Official title: Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nipple Trauma
Keywords: nipple/injure
breastfeeding
pain
laser
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in mothers with nipple trauma during breastfeeding, compared to a control group.

Detailed description: The selection was made through the search of women hospitalized in Accommodation beds with nipple trauma, lifting of stipulated criteria, and inclusion of women in the study upon acceptance and signing of the consent form. To collect the data, a group was formed with people trained as evaluators, responsible for election, randomization, filling of First Assessment and Subsequent Assessment forms, recording of photo images and pain evaluation before and after treatment with laser; and applicators, responsible for laser handling and irradiation. Data collection followed the following order: filling of the first instrument, breast image capture, suckling observation, identification of pain during the child's breast sucking, laser irradiation and re-identification of pain during the child's breast sucking after laser treatment. The collection of data of this form occurred continuously every twelve hours until repair of the nipple trauma or patient discharge. A minimum of two and a maximum of six assessments were carried out, from the inclusion of the patient in the study (taken as zero hour) to 60 hours postpartum. Irradiation, in turn, was performed every 24 hours during the same period, including one to three irradiations per patient in each of the breasts.

Eligibility criteria: Inclusion Criteria:

Women hospitalized in the Accommodation System with their children, feeding exclusively directly from the breast and presenting unilateral or bilateral nipple trauma.

Exclusion Criteria:

Women who were using any other form of treatment for nipple trauma; use of any topical substance in the nipple-areola region; presence of inverted and pseudo-inverted nipple; presence of mastitis; previous history or presence of malignancies; presence of photosensitivity or any adverse reactions to exposure to sunlight; discharge planned for the first day of data collection; women under unfavorable psycho-affective and cognitive situations which prevented assessment of the analog pain scale, photo image record. and observation of breastfeeding; women who had twins, children with gestational age less than 37 weeks, or birth weight less than 2500 grams.

Primary outcomes:
measure: Reduction of nipple pain during breastfeeding
timeFrame: Time - between 12 and 60 hours
Secondary outcomes:
measure: Tissue repair in nipples during breastfeeding
timeFrame: Between 12 and 60 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo - Sao Paulo School of Nursing
Study officials:
affiliation: Student - Federal University of Sao Paulo
name: Kelly P. Coca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Ana CV Abrão, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Monica A. Gamba, PHD
role: PRINCIPAL_INVESTIGATOR
References: