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Effect of LED Photobiomodulation on Analgesia During Labor

Effect of LED Photobiomodulation on Analgesia During Labor: a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03496857
Acronym
EPAL
Enrollment
60
Registered
2018-04-12
Start date
2018-03-28
Completion date
2018-11-20
Last updated
2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

labor pain

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.

Interventions

Three 10-min LED applications will be performed when the patient has a cervical dilatation of 4-5, 6-7, and 8-9 cm. Data on the level of pain, characteristics of the membrane (intact or damaged), heart rate, cardiotocography, and uterine dynamics will be collected after each intervention.

OTHERBath Therapy

The method of analgesia with the bath therapy will be performed using a hot shower at 37°C for 10 min. After showering the entire body or the back for 5 min, the participants will be allowed to direct the water flow to any area of the body that feels the most comfortable and to adjust the temperature themselves for improved comfort. Bath therapy will be performed at three time points during labor: at cervical dilatation of 4-5 cm, 6-7 cm, and 8-9 cm. Data on the level of pain, membrane characteristics (intact or damaged), heart rate, cardiotocography, and uterine dynamics will be collected after the bath therapy by performing the same measurements used in the intervention group.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Statistic evaluation

Intervention model description

RANDOMIZED CLINICAL TRIAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Labor pain20 minutesVisual Analogue Scale Pain

Countries

Brazil

Contacts

Primary ContactLara Motta, PhD
larajmotta@terra.com.br55119998829511
Backup ContactLara Motta, PhD
larajmotta@terra.com.br11998829511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026