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Effect of LED Photobiomodulation on Analgesia During Labor (EPAL)

Primary Purpose

Labor Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Light emitting diode
Bath Therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lara MottaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Photobiomodulation analgesia

bath therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Labor pain
Visual Analogue Scale Pain

Secondary Outcome Measures

Full Information

First Posted
March 28, 2018
Last Updated
April 5, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03496857
Brief Title
Effect of LED Photobiomodulation on Analgesia During Labor
Acronym
EPAL
Official Title
Effect of LED Photobiomodulation on Analgesia During Labor: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
November 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CLINICAL TRIAL
Masking
Outcomes Assessor
Masking Description
Statistic evaluation
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
bath therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Light emitting diode
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bath Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Labor pain
Description
Visual Analogue Scale Pain
Time Frame
20 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Motta, PhD
Phone
55119998829511
Email
larajmotta@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Motta, PhD
Phone
11998829511
Email
larajmotta@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Motta, PhD
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lara Motta
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
18130430
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Motta, PhD
Phone
11998829511
Email
larajmotta@terra.com.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
33760671
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.
Results Reference
derived

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Effect of LED Photobiomodulation on Analgesia During Labor

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