edema pain
Conditions
Interventions
This is a randomized, controlled, double-blind clinical trial with two parallel groups, comprising 68 participants, with 34 participants allocated to the photobiomodulation group and 34 participants a
one assessment at 40 days postpartum
and one assessment at three months postpartum. Pain intensity and threshold, vulvar edema, satisfaction, global perceived change, functionality, urinary incontinence, and sexual function will be asses
Sponsors
Faculdade de Ciências da Saúde do Trairí
Hospital Universitário Ana Bezerra
Eligibility
Sex/Gender
Female
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: Age greater than 15 years; pain score greater than or equal to 3 on the Numerical Pain Rating Scale; presence of first degree and or second degree perineal trauma and or vulvar edema; immediate postpartum period up to 12 hours
Exclusion criteria
Exclusion criteria: Presence of vaginal wounds; Signs or examination that proves vaginal infection; Vulvar hematoma;Difficulty in understanding that makes it impossible to continue the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect a reduction in pain complaints, which will be assessed using the Numerical Rating Scale (NRS) and algometry;Reduction in vulvar edema size, which will be assessed through imaging;Improvement in immediate postpartum functionality assessed using a Likert scale, evaluating the difficulty in standing up, sitting, walking, and baby care, graded from 1 to 5: No difficulty; Mild difficulty; Moderate difficulty; Significant difficulty; Extreme difficulty | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in the duration of pain and edema is expected, which will be measured in hours;We expect an improvement in satisfaction and motivation with the treatment, which will be assessed using the Visual Analogue Scale (VAS), where zero represents a complete absence of satisfaction and ten represents the highest perceived level of satisfaction;Improvement in functionality during the late and remote postpartum periods will be assessed using the WHODAS 2.0 questionnaire;Urinary incontinence in the late postpartum period will be assessed using the ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form), which is a tool used to evaluate the impact of urinary incontinence (UI) on quality of life;Sexual function will be evaluated at 3 months postpartum using the Female Sexual Function Index (FSFI) questionnaire | — |
Countries
BR
Contacts
Public ContactAlianny Raphaely Pereira
Faculdade de Ciências da Saúde do Trairí
Outcome results
None listed