Labor PainEPALNCT03496857
Effect of LED Photobiomodulation on Analgesia During Labor
A study testing Light emitting diode and Bath Therapy in people with Labor Pain, run by University of Nove de Julho at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Light emitting diode and Bath Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Mar 2018to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women who request analgesia during labor
- nulliparous and multiparous
- women with term gestation
- women without previous diseases, including diabetes, neurological diseases.
Who cannot join
- women whose labor is induced with medications;
- women who request drug analgesia during labor;
- women who undergo cesarean delivery
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lara Motta
São Paulo, São Paulo, 18130430
Lara Motta, PhD, 11998829511, larajmotta@terra.com.br
About this study
Official title: 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)].
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Light emitting diode, Bath Therapy
- Keywords
- labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light emitting diodeDevice
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.
Bath TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation analgesia | Experimental | 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. Receives: Device: Light emitting diode |
| bath therapy | Active comparator | 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. Receives: Other: Bath Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor pain
Visual Analogue Scale Pain
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start28 Mar 2018
- Primary completion31 Aug 2018 (estimated)
- Study completion20 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMIZED CLINICAL TRIAL
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
- Investigators
- Lara Motta, PhD, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496857
- Sponsor's protocol ID
- PhotobioLabor01
- Acronym
- EPAL
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33760671
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of LED Photobiomodulation on Analgesia During Labor: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03496857
- Acronym / sponsor ID
- EPAL / PhotobioLabor01
- Conditions
- Labor Pain
- Keywords
- labor pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 20 Nov 2018 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RANDOMIZED CLINICAL TRIAL
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation analgesia | Experimental | Device: Light emitting diodeLED 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. |
| bath therapy | Active comparator | Other: Bath TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women who request analgesia during labor
- nulliparous and multiparous
- women with term gestation
- women without previous diseases, including diabetes, neurological diseases.
Key exclusion criteria (3 listed)
- women whose labor is induced with medications;
- women who request drug analgesia during labor;
- women who undergo cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light emitting diodeThree 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 | Photobiomodulation analgesia |
| Bath TherapyThe 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 |
Primary outcome
Labor pain
Time frame: 20 minutes
Visual Analogue Scale Pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 33760671Traverzim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Motta, PhD principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light emitting diode and Bath Therapy in people with Labor Pain, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Motta, PhD (55119998829511, larajmotta@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor pain (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03496857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.