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

NCT06921174 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-04-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CIAGO - Center for Comprehensive Gynecology and Obstetrics

    collaborator UNKNOWN

  • Carmen Parra Pilates Center

    collaborator UNKNOWN

  • Instituto Sexológico Murciano

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2025-06-01
Completion
2025-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921174 on ClinicalTrials.gov