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Effect of Laser on maternal complications during the Postpartum period

Effect of Photobiomodulation therapy on complications maternal during the Postpartum

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3t8pw38
Enrollment
Unknown
Registered
2024-08-10
Start date
2024-09-20
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

Episiotomy, Laceration of perineum during childbirth, unspecified,

Interventions

This is a two-arm, double-blind, randomized controlled clinical study. After being randomized, women will receive Photobiomodulation Therapy (TFB) in the photobiomodulation intervention group (G_TFB)
E02.779
E02.594

Sponsors

Universidade Federal de Alfenas- Campus Santa Clara
Lead Sponsor
Universidade Federal de Alfenas- Campus Santa Clara
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years; primiparous or multiparous; women after vaginal delivery with grade two, three, or four perineal laceration; women after vaginal delivery with episiotomy; approximation of the edges of the lesion by means of suturing (healing by first intention); pain graded in at least two, by the numerical scale of pain; ability to understand

Exclusion criteria

Exclusion criteria: Refusal to receive the protocol; presence of systemic or lesion-site infectious process; Birth of twins; hemodynamic instability; postpartum complications (hemorrhages); Use of medicines for associated diseases; Smoker; Diabetes mellitus or diabetes Gestational; neurological diseases; cancer

Design outcomes

Primary

MeasureTime frame
Pain assessed by numerical scale and observation of the need to use analgesics through prescriptions. The assessments will take place between the 6th and 12th hour after birth, the 6th hour after the first assessment and the 12th hour after the first assessment. Assessments will take place before the application of photobiomodulation (laser). Totaling three evaluations and two applications. After 7 to 10 days after giving birth, the researcher will make a telephone call to question the woman about her pain. The analogue pain scale (0-10) will be used.

Secondary

MeasureTime frame
Assessment of the healing process using the REEDA scale, which also They will take place between the 6th and 12th hour after birth, the 6th hour after the first assessment and the 12th hour after the first assessment and before the application of photobiomodulation (laser). Totaling three evaluations and 2 applications. After 7 to 10 days after giving birth, the researcher will make a telephone call to question the woman regarding wound healing. A Likert scale will be used (it has improved a lot or it has improved a little or it is the same or it has gotten a little worse or it has gotten a lot worse). Finally, 7 to 10 days after giving birth, via telephone call, the woman will be asked about her satisfaction with the treatment using a Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).

Countries

Brazil

Contacts

Public ContactThais Santos

Universidade Federal de Alfenas- Campus Santa Clara

thaisdecastro856@gmail.com+55 (35) 984566617

Outcome results

None listed

Source: REBEC (via WHO ICTRP)