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

Instituto Sexológico Murciano

Status and phase: Enrolling; Phase 2

Conditions: Pelvic Pain

Treatments: Device: Use of the "Crescendo 2" Intravaginal Device; Procedure: Classical Perineal Massage Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06921174

C.P. ISM-CRE-2024-01

Details and patient eligibility

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 as severe infection or hemorrhage following the procedure.

Willingness to participate and to follow the study protocol.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Classical Perineal Massage Therapy

Active Comparator group

Description:

Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.

Treatment:

Procedure: Classical Perineal Massage Therapy

Use of the "Crescendo 2" Intravaginal Device

Experimental group

Description:

Self-administered perineal massage at home. Three times per week, 10 minutes each session, over a 12-week period.

Treatment:

Device: Use of the "Crescendo 2" Intravaginal Device