Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07480083

Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial.

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife, Pernambuco, 50070-550, Brazil

Location contact

Alexandre M Delgado, PhD

CONTACT

[email protected]

+5581996184843

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low-Level Laser Therapy

Device

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.

Other names: photobiomodulation

Sham treatment

Device

Participants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.

Primary outcomes

  1. Perineal pain intensity (VAS) (immediate)

    Time frame: 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.

  2. Perineal Pain Intensity (VAS) - 24 hours

    Time frame: 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.

  3. Perineal Pain Intensity (VAS) - 48 Hours

    Time frame: 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.

  4. Assessment of wound healing (REEDA) - immediate

    Time frame: 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.

  5. Assessment of Wound Healing (REEDA) - 24 Hours

    Time frame: 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 outcomes

  1. Need for Pharmacological Analgesia

    Time frame: 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.

  2. Global Change Perception Scale (GCPS) Assessment

    Time frame: 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.

  3. Maternal Satisfaction Level

    Time frame: 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.

  4. Adherence to the Intervention

    Time frame: 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.

  5. Adverse Effects of Laser Therapy

    Time frame: 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.

  6. Complications of Perineal Laceration

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leila Katz, PhD

CONTACT

[email protected]

+5581988585977

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

Effectiveness of Low-Level Laser Therapy Compared to Sham Treatment on Pain Intensity and Perineal Wound Healing Quality in the Immediate Postpartum Period: A Randomized Clinical Trial

Acronym: LaserPerineal

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.