NCT06921174 Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
| NCT ID | NCT06921174 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto Sexológico Murciano |
| Condition | Pelvic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-03-27 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06921174 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06921174 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06921174 currently recruiting?
Yes, NCT06921174 is actively recruiting participants. Contact the research team at jesuseugenio@isemu.es for enrollment information.
Where is the NCT06921174 trial being conducted?
This trial is being conducted at Murcia, Spain.
Who is sponsoring the NCT06921174 clinical trial?
NCT06921174 is sponsored by Instituto Sexológico Murciano. The trial plans to enroll 140 participants.