Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 2:06 PM
Study NCT ID:
NCT01723995
Status:
COMPLETED
Last Update Posted:
2018-02-26
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy in Nipples Injured During Breastfeeding
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
Official Title:
Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTNIBF
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: