Effect of LED Photobiomodulation on Analgesia During Labor
NCT ID: NCT03496857
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-03-28
2018-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Dim Light During Labor on Pain, Anxiety, and Labor Progress
NCT07310602
Aromatherapy for Reducing Labor Pain
NCT03098212
The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
NCT05411289
Massage for Pain Relief During the Active Phase of Labor
NCT01392053
Effectiveness of Aromatherapy in Reducing Anxiety and Pain Perception in Women During Childbirth
NCT06849297
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* nulliparous and multiparous
* women with term gestation
* women without previous diseases, including diabetes, neurological diseases.
Exclusion Criteria
* women who request drug analgesia during labor;
* women who undergo cesarean delivery
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nove de Julho
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lara Jansiski Motta
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lara Motta, PhD
Role: PRINCIPAL_INVESTIGATOR
Nove de Julho University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lara Motta
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PhotobioLabor01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.