Clinical trial NCT06921174: Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Official title: Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pelvic Pain
Keywords: postpartum pelvic pain
Lead sponsor: Instituto Sexológico Murciano
Sponsor class: OTHER
Collaborators: name: CIAGO - Center for Comprehensive Gynecology and Obstetrics
name: Carmen Parra Pilates Center
First posted: 2025-04-10
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type: Randomized Controlled Trial (RCT)

Structure: Two parallel groups (random assignment)
Primary purpose: TREATMENT

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:

-

Primary outcomes:
measure: Visual Analogue Scale (VAS) - to assess pain intensity
timeFrame: First measure week 1 and Last measure week 12
Secondary outcomes:
measure: Clinical Global Impression (CGI) - for overall health status
timeFrame: At the end of the treatment week 12
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Instituto Sexológico Murciano
Study officials:
References:
citation: 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.
citation: 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.