Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of the "Crescendo 2" Intravaginal Device, Classical Perineal Massage Therapy.
- Who it may be relevant to
- Registry conditions: Pelvic Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device 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. - Procedure Classical Perineal Massage Therapy
Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.
Primary outcome measures
- Visual Analogue Scale (VAS) - to assess pain intensity [Time frame: First measure week 1 and Last measure week 12]
Secondary outcome measures (1)
- Clinical Global Impression (CGI) - for overall health status [Time frame: At the end of the treatment week 12]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Instituto Sexológico Murciano — Murcia
Publications
- 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. PMID 11853818
- 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. PMID 16437520
Identifiers
NCT: NCT06921174 · C.P. ISM-CRE-2024-01