Pain
Conditions
Interventions
This is a randomized, controlled, triple-blind, three-arm clinical trial. The intervention includes three laser applications at 6-hour intervals and again 24 hours later. The randomization groups are
Sponsors
Escola Paulista de Enfermagem
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo (EERP-USP)
Universidade Estadual de Feira de Santana
Universidade Estadual Paulista Júlio de Mesquita Filho
Universidade Federal de Sergipe
Instituto de Pesquisas Energéticas e Nucleares
Hospital Sofia Feldman
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women with age equal to or greater than 18 years; Who are breastfeeding the child; Who present unilateral or bilateral nipple lesion; Who report three or more points of nipple pain during breastfeeding according to the Numeric Rating Scale (NRS 0 to 10); With a single full-term newborn (equal to or greater than 37 weeks of gestation); With newborn weight equal to or greater than 2500 grams; Speak and read Portuguese
Exclusion criteria
Exclusion criteria: Women with photosensitivity or any adverse reactions to laser light exposure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low-level laser is expected to be effective for analgesia in women with nipple pain, with an average difference of 2 points on the pain scale (VNS) between before and after the intervention in the first 7 and 30 days and its repercussions in the medium term | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to accelerate complete tissue repair of nipple injuries by directly measuring the nipple injury three times during a 24-hour period and completing a form after 5-7 days and 30 days after discharge;It is expected to observe the same pattern of breastfeeding technique, with no differences between the groups, through the observation instrument and breastfeeding three times during the 24-hour period;It is expected to identify and monitor the presence of secondary effects of photobiomodulation in women with different types of coloration of the nipple-areolar region observed directly during breast evaluation three times in a 24-hour period;It is expected to estimate and analyze the incidence of lactational mastitis by having the participant complete forms 30, 60 and 90 days postpartum, in addition to comparing this incidence according to the types of treatments proposed by the photobiomodulation protocol;It is expected to explore the satisfaction of the participants and the perception of the health professionals who work in the joint accommodation regarding the proposed intervention through a qualitative interview carried out at the end with the respective participants | — |
Countries
Brazil
Contacts
Public ContactKelly Coca
Universidade Federal de São Paulo
Outcome results
None listed