Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370910
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-01
Brief Title:
Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration andor Episiotomy on Pain Reduction
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Federal University of Rio Grande do Sul
Study Overview
Official Title:
Comparison of Low-Level Laser Therapy With Cryotherapy in Postpartum Women With Laceration andor Episiotomy on Perineal and Vulvar Pain Reduction
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CL
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 andor 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
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None