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

Not Applicable

Completed

• Conditions: Laceration; Episiotomy; Complications
• Interventions: Other: Low-Level Laser Therapy

• Registration Number: NCT06370910
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Detailed Description

Faced with the scarcity of evidence indicating the best approach to reducing edema and relieving pain in the postpartum period, there is a need to evaluate new methods for pain relief during this time to ensure better well-being for women in the postpartum period.

Lacerations and episiotomies, which can occur during vaginal delivery, exacerbate this pain, making it even more necessary to utilize resources to alleviate discomfort and perineal and vulvar edema, which can consequently worsen pain.

The postpartum period is challenging, with numerous adjustments, and pain can be debilitating, making this period particularly challenging. However, it is possible to minimize it with non-pharmacological interventions.

Cryotherapy has proven to be a valuable resource already utilized in the immediate postpartum period, and low-intensity laser therapy has also demonstrated effectiveness in pain relief, both with low associated risks and costs.

Therefore, it is crucial to compare which therapeutic approach is most effective during the immediate postpartum period.

While vaginal delivery offers many benefits, such as rapid recovery, it can be associated with perineal trauma, leading to pain, breastfeeding difficulties, and discomfort, which directly interfere with activities of daily living The use of an ice pack is inexpensive and effective in relieving pain in the immediate postpartum period, whereas low-level laser therapy (LLLT) promotes tissue repair, enhances wound healing, reduces inflammatory responses, and alleviates pain.

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-10
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

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

Exclusion Criteria

1. Patient who underwent cesarean section;
2. With Help Syndrome;
3. They presented immediate postpartum hemorrhage;
4. They had unstable vital signs in the immediate postpartum period;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Low-Level Laser Therapy	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.
Low-Level Laser Therapy	Low-Level Laser Therapy	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%).

Primary Outcome Measures

Name	Time	Method
To compare two techniques: Low-level laser and cryotherapy	24 horas	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate reduction of swelling using the REEDA scale.	24 hours	The REEDA scale was applied before the intervention was administered and again 24 hours after the intervention was performed.
Pain reduction assessed by McGill Pain Scale	24 hours	The McGill Pain Scale was applied before the technique was performed and again after 24 hours.
Pain reduction assessed by the Visual Analog Scale (VAS).	24 hours	The Visual Analog Scale (VAS) was applied before the intervention was performed, immediately after its implementation, and 24 hours later.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Brazil