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RECRUITING
NCT06921174
PHASE2

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

Sponsor: Instituto Sexológico Murciano

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-03-27

Completion Date

2025-08-31

Last Updated

2025-04-10

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Instituto Sexológico Murciano

Murcia, Murcia, Spain