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Low-level Laser in breastfeeding Pain: a randomized clinical trial

Effectiveness of Photobiomodulation Therapy on Pain during breastfeeding: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5zk8ycg
Enrollment
Unknown
Registered
2022-11-16
Start date
2022-07-27
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastodynia

Interventions

This is a randomized, controlled, double-blind clinical trial. Participants will be divided into three groups: Intervention group 1: application of photobiomodulation therapy in 20 women, irradiating
Intervention group 2: application of photobiomodulation therapy in 20 women, irradiating red light, in contact with the nipple, distributed in two distinct points (north and south), one joule at each
Intervention group 3 (placebo): application of photobiomodulation therapy with placebo effect in 20 women, using light blocking, without compromising the equipment's functioning in relation to the dis
E02.594.540

Sponsors

Escola de Enfermagem de Ribeirão Preto - Universidade de São Paulo
Lead Sponsor
Centro de Referência da Saúde da Mulher
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women over 18 years of age who present unilateral and/or bilateral nipple trauma with pain complaints during the postpartum hospitalization period.

Exclusion criteria

Exclusion criteria: Pain level below 4; using some topical treatment for nipple trauma other than breast milk, with complications or breast surgeries and women with difficulty understanding; newborns with short frenulum; twins; premature infants (less than 36 weeks and 5 days) and those using neonatal phototherapy.

Design outcomes

Primary

MeasureTime frame
Assess the degree of pain 2 hours after the intervention using the Visual Analogue Scale (VAS), applied before (baseline), immediately after the intervention (time 1) and two hours after the intervention (time 2).

Secondary

MeasureTime frame
Evaluate breastfeeding before and after the intervention using the breastfeeding observation assessment form, adapted from the WHO to portuguese.

Countries

Brazil

Contacts

Public ContactBeatriz Fernandes

Escola de Enfermagem de Ribeirão Preto

bboletaf@usp.br+55 (016) 3315-3381

Outcome results

None listed

Source: REBEC (via WHO ICTRP)