Pain, Perineal Healing
Conditions
Brief summary
This randomized clinical trial aims to evaluate the effectiveness of low-level laser therapy compared with sham treatment on pain intensity and perineal wound healing quality in the immediate postpartum period. The study seeks to determine whether low-level laser therapy can reduce perineal pain and improve healing outcomes in women with perineal trauma after vaginal birth.
Interventions
DEVICElow-level laser therapy
Low-level laser therapy will be applied to the perineal region of postpartum women with perineal trauma after vaginal birth. The intervention will be performed using a low-level laser device applied directly to the perineal wound area in the immediate postpartum period. The laser will be administered according to predefined parameters (wavelength, energy density, and application time) to promote analgesia and enhance tissue repair.
DEVICESham treatment
Participants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.
Sponsors
Instituto Materno Infantil Prof. Fernando Figueira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Postpartum women/multiparous women aged 18 years or older; Postpartum women/multiparous women in the immediate postpartum period after vaginal birth; Postpartum women/multiparous women with spontaneous perineal laceration (Grade II, III, or IV); Postpartum women/multiparous women with an average pain score of at least 3 on the Visual Analog Scale (VAS); Labor duration up to 18 hours.
Exclusion criteria
Postpartum women/multiparous women classified as high-risk during pregnancy due to a diagnosis of gestational diabetes mellitus; type 1 or type 2 diabetes mellitus; chronic or pregnancy-specific hypertension; smoking; alcohol use; use of psychoactive substances, among others; Postpartum women/multiparous women who present postpartum complications (such as hemorrhage, difficulty in verbal communication, or sepsis); Postpartum women/multiparous women who develop clinical or hemodynamic complications after childbirth; Postpartum women/multiparous women whose newborns died or were admitted to a Neonatal Intensive Care Unit (NICU); Women with communication difficulties (impaired understanding or mental disorders).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal pain intensity (VAS) (immediate) | 30 minutes | Perineal pain intensity will be assessed using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest. The assessment will be performed in the immediate postpartum period following the intervention. |
| Perineal Pain Intensity (VAS) - 24 hours | 24 hours | Perineal pain intensity will be assessed 24 hours postpartum using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest at 24 hours after delivery. |
| Perineal Pain Intensity (VAS) - 48 Hours | 48 Hours | Perineal pain intensity will be assessed 48 hours postpartum using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest 48 hours after delivery. |
| Assessment of wound healing (REEDA) - immediate | 30 minutes | Perineal wound healing will be assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, and Approximation), a validated instrument used to evaluate the healing process of perineal trauma. Each item is scored from 0 to 3, with total scores ranging from 0 to 15, where lower scores indicate better healing. The assessment will be performed in the immediate postpartum period following the intervention. |
| Assessment of Wound Healing (REEDA) - 24 Hours | 24 Hours | Perineal wound healing will be assessed 24 hours postpartum using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, and Approximation), a validated instrument used to evaluate the healing process of perineal trauma. Each item is scored from 0 to 3, with total scores ranging from 0 to 15, where lower scores indicate better healing. The assessment will be performed 24 hours after delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Pharmacological Analgesia | 48 hours | The need for pharmacological analgesia will be recorded during the postpartum period. This outcome will assess whether participants required analgesic medication for perineal pain management after the intervention. |
| Global Change Perception Scale (GCPS) Assessment | 48 Hours | Participants' perceived overall change in their clinical condition will be evaluated using the Global Change Perception Scale (GCPS). This scale measures the participant's subjective perception of improvement or worsening of symptoms after the intervention. Participants will be asked to rate their perceived change compared with their initial condition. |
| Maternal Satisfaction Level | 48 Hours | Maternal satisfaction with the intervention will be assessed using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 represents "not satisfied at all" and 10 represents "completely satisfied." Participants will be asked to rate their level of satisfaction with the care received during the immediate postpartum period. |
| Adherence to the Intervention | 48 Hours | Adherence to the intervention will be evaluated by recording participants' compliance with the assigned treatment protocol. This outcome will assess whether participants received and completed the intervention as planned during the study period. |
| Adverse Effects of Laser Therapy | 48 Hours | Adverse effects associated with laser therapy will be monitored and recorded throughout the study period. Participants will be assessed for the presence of potential adverse events, including itching (pruritus), tingling sensation (paresthesia), and blister formation at the application site. |
| Complications of Perineal Laceration | 48 Hours | Complications related to perineal laceration will be monitored and recorded during the postpartum period. These complications include suture dehiscence, surgical site infection, need for surgical reintervention, and postpartum wound bleeding. |
Countries
Brazil
Contacts
CONTACTLeila Katz, PhD
Outcome results
None listed