Status:
RECRUITING
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Lead Sponsor:
Instituto Sexológico Murciano
Collaborating Sponsors:
CIAGO - Center for Comprehensive Gynecology and Obstetrics
Carmen Parra Pilates Center
Conditions:
Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06921174
Start Date
March 27 2025
End Date
August 31 2025
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Sexológico Murciano
Murcia, Murcia, Spain, 30007