Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-25 @ 4:03 PM
Study NCT ID:
NCT03496857
Status:
UNKNOWN
Last Update Posted:
2018-04-12
First Post:
2018-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of LED Photobiomodulation on Analgesia During Labor
Sponsor:
University of Nove de Julho
Organization:
Study Overview
Official Title:
Effect of LED Photobiomodulation on Analgesia During Labor: a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
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:
EPAL
Brief Summary:
The aim of this study is to valuate the effects of LED photobiomodulation on analgesia during labor.ight-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.n total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into two groups: intervention group \[analgesia with LED therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\].
Detailed Description:
Background: Labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. Pharmacological and nonpharmacological analgesia methods are used to control labor pain. Epidural analgesia is the most commonly used pharmacological analgesia method. However, it may have side effects on the fetus and the mother. Light-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.
Objectives: To evaluate the effects of LED photobiomodulation on analgesia during labor.
Methods: In total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into two groups: intervention group \[analgesia with LED therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\]. The perception of pain will be assessed using the visual analogue scale (VAS), with a score from 0 to 10 at baseline, i.e., before the intervention. In both the groups, the procedures will last 10 min and will be performed at three time points during labor: during cervical dilation of (1) 4-5 cm, (2) 6-7 cm, and (3) 8-9 cm. At all three time points, pain perception will be evaluated using VAS shortly after the intervention. In addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points.
Expected outcomes: The use of LED photobiomodulation will have an analgesic effect superior to that of the bath therapy.
Objectives: To evaluate the effects of LED photobiomodulation on analgesia during labor.
Methods: In total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into two groups: intervention group \[analgesia with LED therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\]. The perception of pain will be assessed using the visual analogue scale (VAS), with a score from 0 to 10 at baseline, i.e., before the intervention. In both the groups, the procedures will last 10 min and will be performed at three time points during labor: during cervical dilation of (1) 4-5 cm, (2) 6-7 cm, and (3) 8-9 cm. At all three time points, pain perception will be evaluated using VAS shortly after the intervention. In addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points.
Expected outcomes: The use of LED photobiomodulation will have an analgesic effect superior to that of the bath therapy.
Study Oversight
Has Oversight DMC:
False
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?: