Effect of Laser Therapy to Reduce Pain and Scarring in Postpartum Wome

Not Applicable

Recruiting

• Conditions: Fissure and fistula of nipple; O92.1

• Registration Number: RBR-2bxfbk8
• Lead Sponsor: niversidade de Pernambuco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-05
• Last Update Posted: 5 March 2024
• Study Completion: 2024-12-20

Recruitment & Eligibility

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

Inclusion Criteria

Women; age from 18 years until 41 years; primiparous or multiparous; postpartum women up to 15 days postpartum; with some degree of nipple injury resulting from breastfeeding; babies born weighing at least 2500g; single pregnancy; in exclusive breastfeeding; no history of interventions with laser therapy in the previous 15 days; able to speak and understand the Portuguese language; who show interest in the project; be able to attend the Women's Health Research Laboratory (LAPESM); who can receive calls and messages via Whatsapp within 48 hours of the intervention; who sign the Free and Informed Consent Form (TCLE);

Exclusion Criteria

Women with inverted or pseudo-inverted nipples; who have mastitis during the intervention period; to start using antibiotic anti-inflammatory analgesics or any topical substance on the nipple (except breast milk); with photosensitivity or any adverse reaction to exposure to sunlight;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study will evaluate the acute effect of photobiomodulation in the red and infrared range, on changes in the perception of pain intensity, in relation to nipple injury, through the numeric pain scale (0-10 points) and the Short Form questionnaire McGill (for descriptive pain data), all assessments will occur before and after each intervention.

Secondary Outcome Measures

Name	Time	Method
The study will evaluate the acute effect of photobiomodulation in the red (660nm) and infrared (880nm) range, on the healing of the nipple lesion and on the signs of inflammation, using measurements in millimeters with a measuring tape for each lesion and a checklist of the five signs of inflammation, all assessments will occur before and after each intervention. The patients' global perception of change with photobiomodulation after 24 hours of the second intervention, the degree of satisfaction of the participants, immediately after the second intervention, with regard to the physiotherapeutic intervention, as well as any side effects arising from the applied intervention will also be evaluated.