Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation (NCT04896034) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation
France480 participantsStarted 2021-05-06
Plain-language summary
Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, alternative, soft technology, based on a cross action of LED light emission, a low intensity nanopulsed laser and a magnetic tunnel. The sessions last 10 minutes each, in total in the study two sessions will be delivered.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman aged 18 years or older
* Primi or multiparous patient
* Natural childbirth, regardless of the method of extraction (spontaneous, vacuum, forceps), and damage to the perineum (simple tear, episiotomy, obstetric anal sphincter injury)
* Patients affiliated to a health insurance plan
* Agreeing to participate in the study and having signed an informed consent
Exclusion Criteria:
* Immediate complications related to the childbirth and requiring management in the continuing care unit (delivery haemorrhage, eclampsia, etc.)
* Severe neonatal complications requiring reanimation.
* Patient with a cardiac pacemaker
* Presence of a disease and/or taking photo-sensitising treatment
* Patient under legal protection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients
Timeframe: 30 minutes after first PBM session for the experimental and control 1 groups
2
Evaluation of the effectiveness of photobiomodulation on pain in immediate postpartum patients
Timeframe: 30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2