Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Recruiting now · Phase 2
Conditions studied: Pelvic Pain
In brief
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.
Key facts
- Study ID
- NCT06921174
- Run by
- Instituto Sexológico Murciano
- People needed
- 140
- Starts
- 2025-03-27
- Expected to finish
- 2025-08-31
- Last updated by the study team
- 2025-04-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
Where it is running
- Instituto Sexológico Murciano — Murcia, Murcia, Spain (enrolling)
Full record on ClinicalTrials.gov
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