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

Last updated: April 3, 2025
Sponsor: Instituto Sexológico Murciano
Overall Status: Active - Recruiting

Phase

2

Condition

Dysmenorrhea (Painful Periods)

Treatment

Use of the "Crescendo 2" Intravaginal Device

Classical Perineal Massage Therapy

Clinical Study ID

NCT06921174
C.P. ISM-CRE-2024-01
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

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.

Exclusion

Exclusion Criteria:

  • Presence of severe conditions such as:

  • Excessive postpartum hemorrhage

  • Serious infections

  • Respiratory or circulatory complications

  • Neurological disorders requiring intensive medical intervention

  • Currently under pharmacological treatment for pelvic pain.

  • Active vaginal infections.

  • Expressed refusal to participate or inability to comply with study procedures.

  • Women with episiotomy may participate only if there were no complications such assevere infection or hemorrhage following the procedure.

Willingness to participate and to follow the study protocol.

Exclusion Criteria:

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Use of the "Crescendo 2" Intravaginal Device
Phase: 2
Study Start date:
March 27, 2025
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Instituto Sexológico Murciano

    Murcia, 30007
    Spain

    Active - Recruiting

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