Radiofrequency Technic's Impact on Perineal Postpartum Pain
Study Details
Study Description
Brief Summary
A study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery.
Severe pain that is not taken into account can become chronic pain. It has physical and psychological consequences. It is therefore essential to prevent these risks in young mothers.
The main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions.
A double-blind randomized prospective single-center study will be conducted on patients delivering at Marseille's north hospital.
Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study.
Patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency.
The duration of inclusion is provided over 6 months. Each topic will be followed over a period of 1 month. The total study duration is 7 months.
The expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. Also an improvement in the quality of life of patients during the first days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patient treated with fake radiofrequencer
|
Device: Radiofrequencer
Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization
|
| Experimental: Patient treated with radiofrequencer
|
Device: Radiofrequencer
Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization
|
Outcome Measures
Primary Outcome Measures
- Pain score using analogical pain scale [30 minutes]
Pain score will be assessed before and after the radiofrequencing cession
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps
-
Patients presenting perineal lesions
Exclusion Criteria:
- Patients who delivered through cesarean section
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique Hôpitaux de Masreille | Marseille | France | 13014 |
Sponsors and Collaborators
- Assistance Publique Hopitaux De Marseille
Investigators
- Study Director: Urielle DESALBRES, Assistance Publique Hôpitaux de Marseille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-43
- 2016-A01499-42