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

Laceration Clinical Trial

— CL  

Official title:

Comparison of Low-Level Laser Therapy With Cryotherapy in Postpartum Women With Laceration and/or Episiotomy on Perineal and Vulvar Pain Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06370910
• Other study ID #: CAAE 58569421.5.0000.5327
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: April 2024
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 10, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Episiotomy; Complications
• Laceration
• Lacerations

Intervention

Other:
• Low-Level Laser Therapy
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain reduction assessed by the Visual Analog Scale (VAS).	The Visual Analog Scale (VAS) was applied before the intervention was performed, immediately after its implementation, and 24 hours later.	24 hours
Secondary	Pain reduction assessed by McGill Pain Scale	The McGill Pain Scale was applied before the technique was performed and again after 24 hours.	24 hours
Secondary	Evaluate reduction of swelling using the REEDA scale.	The REEDA scale was applied before the intervention was administered and again 24 hours after the intervention was performed.	24 hours