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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Type: Randomized Controlled Trial (RCT)

Structure: Two parallel groups (random assignment)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Classical Perineal Massage Therapy

Performed manually by a pelvic floor physiotherapist.

One 30-minute session per week for 12 weeks.

Group Type ACTIVE_COMPARATOR

Classical Perineal Massage Therapy

Intervention Type PROCEDURE

Performed manually by a pelvic floor physiotherapist.

One 30-minute session per week for 12 weeks.

Use of the "Crescendo 2" Intravaginal Device

Self-administered perineal massage at home.

Three times per week, 10 minutes each session, over a 12-week period.

Group Type EXPERIMENTAL

Use of the "Crescendo 2" Intravaginal Device

Intervention Type DEVICE

Self-administered perineal massage at home with Crescendo device.

Three times per week, 10 minutes each session, over a 12-week period.

Interventions

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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.

Intervention Type DEVICE

Classical Perineal Massage Therapy

Performed manually by a pelvic floor physiotherapist.

One 30-minute session per week for 12 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No