Actively Recruiting
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Led by Instituto Sexológico Murciano · Updated on 2025-04-10
140
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
Sponsors
I
Instituto Sexológico Murciano
Lead Sponsor
C
CIAGO - Center for Comprehensive Gynecology and Obstetrics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 primary outcome measure and the Clinical Global Impression Scale as the secondary outcome measure.
CONDITIONS
Official Title
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Living in the Region of Murcia
- Had a vaginal delivery between 6 weeks and 12 months ago
- Experiencing postpartum perineal pain coded as GA34.01
- Have not received previous treatment for this condition
You will not qualify if you...
- Severe conditions such as excessive postpartum bleeding, serious infections, respiratory or circulatory problems, or neurological disorders requiring intensive care
- Currently taking medication for pelvic pain
- Active vaginal infections
- Refusal to participate or inability to follow the study procedures
- Women with episiotomy only if no complications like severe infection or bleeding occurred after the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Instituto Sexológico Murciano
Murcia, Murcia, Spain, 30007
Actively Recruiting
Research Team
J
Jesús Eugenio Dr. Rodríguez Martínez, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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