Instituto Sexológico Murciano
Murcia, 30007, Spain
Location status: Recruiting
NCT Number: NCT06921174
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
Murcia, 30007, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Willingness to participate and to follow the study protocol.
Exclusion criteria
-
Self-administered perineal massage at home with Crescendo device.
Three times per week, 10 minutes each session, over a 12-week period.
Performed manually by a pelvic floor physiotherapist.
One 30-minute session per week for 12 weeks.
Time frame: First measure week 1 and Last measure week 12
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: At the end of the treatment week 12
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.
Contact information is provided by the study sponsor or research team.
Instituto Sexológico Murciano
Other
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