PainLaserPerinealNCT07480083
Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial.
A study testing low-level laser therapy in people with Pain and Perineal Healing, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Perineal Healing
- What is being tested?
- low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife, Pernambuco, 50070-550
Alexandre M Delgado, PhD, +5581996184843, alexmagno_d@hotmail.com
About this study
Official 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
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.
- Conditions
- Pain, Perineal Healing
- Being tested
- low-level laser therapy, Sham treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser therapyDevice
Also called photobiomodulation
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.
Sham treatmentDevice
Participants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | low-level laser therapy Receives: Device: low-level laser therapy |
| Control | Sham comparator | sham treatment Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal pain intensity (VAS) (immediate)
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.
Measured: 30 minutes
Perineal Pain Intensity (VAS) - 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.
Measured: 24 hours
Perineal Pain Intensity (VAS) - 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.
Measured: 48 Hours
Assessment of wound healing (REEDA) - immediate
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.
Measured: 30 minutes
Assessment of Wound Healing (REEDA) - 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.
Measured: 24 Hours
Secondary outcomes (6)
Need for Pharmacological Analgesia
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.
Measured: 48 hours
Global Change Perception Scale (GCPS) Assessment
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.
Measured: 48 Hours
Maternal Satisfaction Level
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.
Measured: 48 Hours
Adherence to the Intervention
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.
Measured: 48 Hours
Adverse Effects of Laser Therapy
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.
Measured: 48 Hours
Complications of Perineal Laceration
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.
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480083
- Sponsor's protocol ID
- LaserPerineal
- Other IDs
- 92318425.0.0000.5201
- Acronym
- LaserPerineal
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07480083
- Acronym / sponsor ID
- LaserPerineal / LaserPerineal
- Conditions
- Pain, Perineal Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: low-level laser therapylow-level laser therapy |
| Control | Sham comparator | Device: Sham treatmentsham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level laser therapyAlso: photobiomodulationLow-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. | Device | Experimental group |
| Sham treatmentParticipants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive. | Device | Control |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
Need for Pharmacological Analgesia
Time frame: 48 hours
Global Change Perception Scale (GCPS) Assessment
Time frame: 48 Hours
Maternal Satisfaction Level
Time frame: 48 Hours
Adherence to the Intervention
Time frame: 48 Hours
Adverse Effects of Laser Therapy
Time frame: 48 Hours
Complications of Perineal Laceration
Time frame: 48 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser therapy in people with Pain and Perineal Healing, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Katz, PhD (+5581988585977, leilakatz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal pain intensity (VAS) (immediate) (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.