Effect of LED Photobiomodulation on Analgesia During Labor

Labor Pain Clinical Trial

— EPAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03496857
• Other study ID #: PhotobioLabor01
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2018
• Last updated: April 5, 2018
• Start date: March 28, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: April 2018
• Source: University of Nove de Julho
• Contact: Lara Motta, PhD
• Phone: 55119998829511
• Email: larajmotta[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 20, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Light emitting diode
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.

Other:
• Bath 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.

Locations

Country	Name	City	State
Brazil	Lara Motta	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Labor pain	Visual Analogue Scale Pain	20 minutes