Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intrav… (NCT06921174) | Clinical Trial Compass
RecruitingPhase 2
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Spain140 participantsStarted 2025-03-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale (VAS) - to assess pain intensity
Timeframe: First measure week 1 and Last measure week 12