Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Recruiting
Phase 2
Interventional Study
Pelvic Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Instituto Sexológico Murciano · Other
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About This Trial
GA34.01 postpartum, a randomized design with a parallel group structure will be applied, randomly assigning participants into two groups. The first group will receive the traditional perineal massage therapy, while the second group will use the intravaginal device "Crescendo 2." In this study, a pre- and post-intervention evaluation will be conducted, using the Visual Analog Scale (VAS) as the pri…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women aged 18 years or older.
* Residing in the Region of Murcia.
* Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
* Presenting postpartum perineal pain, coded in ICD-11 as GA34.01.
* Have not received any prior treatment for this condition.
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Contacts