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| Name | Class |
|---|---|
| CIAGO - Center for Comprehensive Gynecology and Obstetrics | UNKNOWN |
| Carmen Parra Pilates Center | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classical Perineal Massage Therapy | Active Comparator | Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks. |
|
| Use of the "Crescendo 2" Intravaginal Device | Experimental | Self-administered perineal massage at home. Three times per week, 10 minutes each session, over a 12-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of the "Crescendo 2" Intravaginal Device | Device | Self-administered perineal massage at home with Crescendo device. Three times per week, 10 minutes each session, over a 12-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | First measure week 1 and Last measure week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Willingness to participate and to follow the study protocol.
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesús Eugenio Dr. RodrÃguez MartÃnez, Phd | Contact | +34639238413 | jesuseugenio@isemu.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Sexológico Murciano | Recruiting | Murcia | Murcia | 30007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11853818 | Result | Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002 Feb 9;359(9305):515-9. doi: 10.1016/S0140-6736(02)07683-3. | |
| 16437520 | Result | Beckmann MM, Garrett AJ. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005123. doi: 10.1002/14651858.CD005123.pub2. |
| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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Type: Randomized Controlled Trial (RCT)
Structure: Two parallel groups (random assignment)
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| Classical Perineal Massage Therapy | Procedure | Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks. |
|
| At the end of the treatment week 12 |
| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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