Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06370910 |
Other study ID # |
CAAE 58569421.5.0000.5327 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.