Effect of LED Photobiomodulation on Analgesia During Labor (EPAL)

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

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)].

Study Overview

• Status: Unknown
• Conditions: Labor Pain
• Intervention / Treatment: Device: Light emitting diode; Other: Bath Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 18130430
      • Recruiting
      • Lara Motta
      • Contact: Lara Motta, PhD; Phone Number: 11998829511; Email: larajmotta@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation analgesia; LED therapy sessions will be held in the pre-labor room. The patient who will undergo analgesia and the professional responsible for placing the LED plate on the patient's back, between T10 and L2, will be present at the time of the intervention. The LED plate will be covered with clear disposable plastic (PVC) to avoid cross-contamination and ensure hygiene. During the interventions, the patient will be allowed to choose the position that is the most comfortable for her. 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor pain	Visual Analogue Scale Pain	20 minutes

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Lara Motta, PhD, Nove de Julho University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): November 20, 2018

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: labor pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: PhotobioLabor01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No