Clinical trial NCT03496857: Effect of LED Photobiomodulation on Analgesia During Labor
Official title: Effect of LED Photobiomodulation on Analgesia During Labor: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Keywords: labor pain
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CLINICAL TRIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* women who request analgesia during labor
* nulliparous and multiparous
* women with term gestation
* women without previous diseases, including diabetes, neurological diseases.

Exclusion Criteria:T

* women whose labor is induced with medications;
* women who request drug analgesia during labor;
* women who undergo cesarean delivery

Primary outcomes:
measure: Labor pain
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Lara Motta
state: Sao Paulo
Study officials:
affiliation: Nove de Julho University
name: Lara Motta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Traverzim MA, Sobral APT, Fernandes KPS, de Fatima Teixeira Silva D, Pavani C, Mesquita-Ferrari RA, Horliana ACRT, Gomes AO, Bussadori SK, Motta LJ. The Effect of Photobiomodulation on Analgesia During Childbirth: A Controlled and Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2021 Apr;39(4):265-271. doi: 10.1089/photob.2020.4976. Epub 2021 Mar 23.