aser for pain relief in Nipple and Perineal Trauma in postpartum

Not Applicable

Recruiting

• Conditions: Mastitis; Episiotomy; Lacerations; Pain; C12.050.703.844

• Registration Number: RBR-2qm8jrp
• Lead Sponsor: Centro de Atenção Integral à Saúde da Mulher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-13
• Last Update Posted: 13 November 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for the Nipple Trauma group: Older than 18 years; Who are breastfeeding and have nipple trauma; Present understanding of the Portuguese language and cognitive ability to consent; Reporting nipple pain of at least 4 (four) on the visual analogue scale (VAS) at the time of approach.

Inclusion criteria for the Perineal Trauma group: Older than 18 years; Who have perineal injuries resulting from childbirth (episiotomy or 2nd-degree laceration, at least); Reporting perineal pain of at least 4 (four) on the visual analogue scale (VAS) at the time of the approach; Present understanding of the Portuguese language and cognitive ability to consent.

Exclusion Criteria

Exclusion criteria for the Nipple Trauma group: Mastitis or neoplasm; Photosensitivity to exposure to sunlight; Breast malformation, breast implant, or breast reduction surgery.
Exclusion criteria for the Perineal Trauma group: Active gynecological infections; Unresolved puerperal hemorrhage.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In the perineal trauma arm: With the application of photobiomodulation, a significant reduction in mean pain is expected in the experimental group compared to the sham group, using the Short Form McGill Pain Questionnaire (observing a minimum reduction of 5 points in the Pain Index). Pain Rating; 1 point on the Present Pain Intensity Scale; and 1.37 cm on the Visual Analogue Scale) and the Numerical Pain Assessment Scale (observing a minimum reduction of 2 points).<br><br>In the nipple trauma arm: With the application of photobiomodulation, a significant reduction in mean pain is expected in the experimental group compared to the sham group, using the Visual Analogue Scale (observing a minimum reduction of 1.37 cm) and the Numerical Scale of Pain Assessment (observing a minimum reduction of 2 points).

Secondary Outcome Measures

Name	Time	Method
In both arms, healing and satisfaction will be evaluated through a telephone interview, using a Likert scale, presenting the percentile of improvement in healing and satisfaction.