Pain
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial that will include women aged 18 to 40 years within the first 12 hours after a cesarean section. Patients will be randomized 1:1 on
Sponsors
Faculdade de Ciências da Saúde do Trairi
Hospital Universitário Ana Bezerra
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Women who have undergone a cesarean section; aged between 18 and 40 years; in the first 12 hours after delivery of a single fetus; with or without a history of diabetes; and systemic arterial hypertension of previous origin or acquired during the gestational period; who agree to participate in the research, agreeing to sign the Free and Informed Consent Form (FICF)
Exclusion criteria
Exclusion criteria: Women who do not complete all assessments; those who present any complication such as hemorrhage; post-cesarean wound dehiscence; or sepsis; women with ineffective communication during the research period that compromises understanding and responses to assessments; presence of cancer or suspicion of cancer; skin hypersensitivity; use of photosensitizing medications, in case of epilepsy; and changes in sensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess pain; We hope to determine the level of pain reported by women undergoing cesarean sections 12 hours after delivery and identify whether there is a difference in this pain before and after photobiomodulation. Using the self-reported assessment method using the Numerical Pain Rating Scale (NPS), we can then identify whether there is a significant reduction in this outcome after the first and second treatment sessions, respectively 12 hours postpartum and 24 hours after the first application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess healing; We hope to determine whether there is a difference in the cesarean section scarring process between women who received photobiomodulation and those who received the placebo. The Patient Scar Assessment Questionnaire (PSAQ) will be used as an assessment method. It consists of 39 questions divided into five subscales: appearance, symptoms, perception, satisfaction with appearance and symptoms. This validated scale was translated into Portuguese and adapted to Brazilian culture. This assessment will occur twice: in the first month (day 15 and 30 after the cesarean section), and in the second and third months after the cesarean section, to identify whether cesarean section healing during this period was different between the group that received photobiomodulation and those that received the placebo treatment.;Assess function; We expect to find the level of difficulty with which participants are able to perform daily activities, taking into account the limitation imposed by changes in body structure (ICF: s7601, s7602) and body functions related to pain (ICF: b280) and movement (ICF: b7602, b7603), and how these may affect the activities of standing up (ICF: d4201; d4104), sitting down (ICF: d4103; d4200), walking (ICF: d4500) and caring for the baby (ICF: d6600; d6601; d6604; d6605); Verified by the method of applying a Likert-type scale, where participants will assign a score from 1 to 5 (1 - No difficulty, 2 - Mild difficulty, 3 - Moderate difficulty, 4 - Significant difficulty and 5 - Extreme difficulty), according to the degree of difficulty perceived to perform each of these activities, and thus identify whether the degree of difficulty reported by them will be changed after the application of photobiomodulation, and whether there is a difference in relation to those who received only the placebo treatment | — |
Countries
Brazil
Contacts
Public ContactMagdalena Brilhante
Faculdade de Ciências da Saúde do Trairi
Outcome results
None listed