NCT06921174

Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Instituto Sexológico Murciano · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Pelvic Pain

Interventions

Type	Name	Description
DEVICE	Use of the "Crescendo 2" Intravaginal Device	Self-administered perineal massage at home with Crescendo device. Three times per week, 10 minutes each session, over a 12-week period.
PROCEDURE	Classical Perineal Massage Therapy	Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.

Timeline

• Start date: 2025-03-27
• Primary completion: 2025-06-01
• Completion: 2025-08-31
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

1 site across 1 country: Spain