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Effects of Laser on pain and return of sexual function after postpartum Perineal Trauma: a feasibility study

Effects of Photobiomodulation on pain and return of sexual function after obstetric spontaneous Perineal Laceration: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-536hkwg
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-05-01
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

Laceration of perineum during childbirth, unspecified

Interventions

This is a feasibility study through a two-arm randomized controlled clinical trial, blinded to the evaluator. The sample will consist of volunteer women from the Maternity Ward of the Cassiano Antônio
E02.594.540

Sponsors

Hospital Universitário Cassiano Antonio Moraes (HUCAM) da Universidade Federal do Espírito Santo
Lead Sponsor
Universidade Federal do Espírito Santo
Collaborator

Eligibility

Sex/Gender
Female
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: Postpartum women treated at the Maternity of Hospital Antônio Cassiano de Moraes (HUCAM); normal birth with spontaneous perineal laceration of any degree; Singleton pregnancy; aged 16 or over; completion of the free and informed consent form

Exclusion criteria

Exclusion criteria: Infectious disease; hemorrhoid; bruise or varicose veins in the perineum

Design outcomes

Primary

MeasureTime frame
It is expected that the single-blind randomized controlled clinical trial is feasible, assessed by calculating the recruitment rate, adherence rate, acceptability of the intervention, safety of the intervention, and collection of outcomes. Data will be collected during the intervention days, 15, 30, and 60 days postpartum.—

Secondary

MeasureTime frame
A recruitment rate of 50% is expected by calculating the percentage of eligible women who will be recruited to participate in the study during the data collection period.;A 90% adherence rate is expected by calculating the percentage of eligible and recruited women who adhered to the proposed intervention throughout the data collection period.;An intervention acceptability rate of 80% is expected by calculating the percentage of eligible and recruited women who will agree to participate in the study during the data collection period.;The intervention is expected to be safe, with 20% of participants reporting some type of discomfort caused by the intervention and 90% satisfaction with the intervention during the data collection period.—

Countries

Brazil

Contacts

Public ContactFernanda Liberato

Universidade Federal do Espírito Santo

nandamayrink@yahoo.com.br+55(27)98135-8610

Outcome results

None listed

Source: REBEC (via WHO ICTRP)