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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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%). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain reduction assessed by McGill Pain Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | RS | Brazil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2024 | Apr 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | Apr 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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randomized clinical trial
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The McGill Pain Scale was applied before the technique was performed and again after 24 hours. |
| 24 hours |
| 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 |