Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction

NCT06370910 | Completed

• 1 other identifier: CAAE 58569421.5.0000.5327
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery. Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies. Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies. Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery.

Conditions

Episiotomy; Complications; Laceration

Keywords

Cryotherapy; Low level Laser Therapy;

Outcome Measures

Primary Outcomes (1)

• To compare two techniques: Low-level laser and cryotherapy

  The use of low-level laser therapy or cryotherapy to alleviate pain. Cryotherapy was performed using a glove containing crushed ice, applied to the perineal region for 20 minutes, initiated within 12 hours postpartum. Patients were evaluated before the application, immediately after the application, and 24 hours after the application. Low-level laser therapy, as well as cryotherapy, was applied within 12 hours after delivery, targeting the site of the injury with red radiation. The applied dose was 3 joules, administered in a punctual manner, using a non-contact technique, with a distance of 2 cm between each point. Subsequently, infrared laser therapy was applied using conventional contact technique around the extent of the injury, with a punctual application of 6 joules, also maintaining a distance of 2 cm between each point.

  24 horas

Secondary Outcomes (3)

• Pain reduction assessed by the Visual Analog Scale (VAS).

  24 hours

• Pain reduction assessed by McGill Pain Scale

  24 hours

• Evaluate reduction of swelling using the REEDA scale.

  24 hours

Study Arms (2)

Cryotherapy

ACTIVE COMPARATOR

Cryotherapy will be performed using a glove containing crushed ice applied to the perineum region for 20 minutes, starting within 12 hours postpartum. The patients will be evaluated before the application, immediately after the application, immediately after the application and in 24 hours after the application. A glove containing crushed ice will be used because it is more anatomical and extends throughout the perineum region. The indicates that ice on the surface has the ability to decrease the temperature of the skin and intramuscular tissue. Compared to other cryotherapy techniques like gel and frozen pea pack, ice pack is the most adopted technique for perineal pain relief. The application time depends on the study, which indicates that 20 minutes is enough time to cause a reduction and relief of pain in the participants of their study.

Other: Low-Level Laser Therapy

Low-Level Laser Therapy

ACTIVE COMPARATOR

Within 12 hours postpartum, red light radiation will be applied at the site of the injury, with 3 joules applied promptly. The non-contact technique will be used, maintaining a distance of 2 cm between each point. Subsequently, infrared laser will be applied using conventional contact technique, around the extent of the injury. 6 joules will be applied punctually, also with a distance of 2 cm between each point. The LLLT device used will be the DMC brand Therapy EC, portable, with a lithium-ion battery. The red laser will have a wavelength of 660nm (+- 10 nm), with an emitter power of 100 mw (+- 20%). The infrared laser will have a wavelength of 808 nm (+- 10), with an emitter power of 100 mw (+- 20%).

Other: Low-Level Laser Therapy

Interventions

Low-Level Laser Therapy OTHER

The patient will be submitted to evaluation through a questionnaire, which will be the patient's evaluation form, which will be elaborated by the researcher (Appendix A). Next, pain and edema will be evaluated, using the VAS scales, Mc Gill scale and REEDA scale, after this process, the therapy will be applied, and the patient will be randomly selected for cryotherapy or LLLT. After application, the patient will be evaluated immediately and the scales applied again and after 24 hours.

Also known as: Cryotherapy

Cryotherapy; Low-Level Laser Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient who underwent vaginal delivery;
• Had a grade 1 or grade 2 laceration;
• Have undergone episiotomy;

You may not qualify if:

• Patient who underwent cesarean section;
• With Help Syndrome;
• They presented immediate postpartum hemorrhage;
• They had unstable vital signs in the immediate postpartum period;

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, RS, Brazil

Location

MeSH Terms

Conditions

Lacerations

Interventions

Low-Level Light Therapy; Cryotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Principal

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 17, 2024
• Study Start: August 1, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 10, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)