Comparing perineal massage therapy and an intravaginal device for postpartum pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of classical perineal massage therapy against the use of an intravaginal device called 'Crescendo 2' in reducing postpartum perineal pain. Participants will be randomly assigned to one of two groups, with one receiving traditional massage therapy and the other using the intravaginal device. The primary outcome will be measured using the Visual Analog Scale (VAS), while the Clinical Global Impression Scale will serve as a secondary measure. The study aims to provide insights into the best approach for alleviating pelvic pain in postpartum women.

Why it matters

Who can join: the full rules

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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Where it's running

• Instituto Sexológico Murciano
  Murcia, Murcia, Spain Recruiting

Study contacts

• Study coordinator: Jesús Eugenio Dr. Rodríguez Martínez, Phd
• Email: jesuseugenio@isemu.es
• Phone: +34639238413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.