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

Phase 2RecruitingNCT06921174

Instituto Sexológico Murciano140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Pelvic Pain

Interventions

Use of the "Crescendo 2" Intravaginal Device

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS) - to assess pain intensity

The \*\*Visual Analogue Scale (VAS)\*\* will be used as the \*\*primary outcome measure\*\*. It consists of a horizontal line approximately 10 centimeters long. At each end of the line are the extreme expressions of pain: on the left, "no pain," and on the right, "worst imaginable pain." This tool allows us to measure the intensity of pain with high reproducibility between observers. Visual Analogue Scale (VAS): The Visual Analogue Scale is a psychometric response scale used to measure pain intensity. It typically consists of a 10-centimeter horizontal line anchored by two verbal descriptors: "no pain" (score = 0) and "worst imaginable pain" (score = 10). Minimum score: 0 (no pain) Maximum score: 10 (worst imaginable pain) Interpretation: Higher scores indicate worse outcomes (i.e., more intense pain).

Time frame: First measure week 1 and Last measure week 12

Secondary Outcomes

Clinical Global Impression (CGI) - for overall health status

The Clinical Global Impression Scale (CGI) will be used as the secondary outcome measure. The Global Impression Scale (GIC) is a subjective tool used to assess the overall perceived change in a patient's health status, particularly in clinical studies involving various conditions and treatments. Clinical Global Impression - Change (CGI-C) Scale: The Clinical Global Impression - Change scale is a clinician-rated tool used to assess changes in a patient's condition over time, relative to baseline. Minimum score: 1 (very much improved) Maximum score: 7 (very much worse) Interpretation: Lower scores indicate better outcomes (i.e., greater clinical improvement), while higher scores indicate worsening.

Time frame: At the end of the treatment week 12