Comparing perineal massage therapy and an intravaginal device for postpartum pain relief
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
This study is testing whether perineal massage or a special intravaginal device can help new mothers feel less pain after giving birth.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Instituto Sexológico Murciano Academic / other |
| Locations | 1 site (Murcia, Murcia) |
| Trial ID | NCT06921174 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 years or older who have experienced vaginal delivery within the last 6 to 12 months and are suffering from postpartum perineal pain.
Not a fit: Patients with severe complications from childbirth, active infections, or those currently receiving treatment for pelvic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for women suffering from postpartum perineal pain.
How similar studies have performed: While similar approaches have been explored, this specific comparison of perineal massage therapy and an intravaginal device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Murcia, Murcia
- Instituto Sexológico Murciano — Murcia, Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Jesús Eugenio Dr. Rodríguez Martínez, Phd
- Email: jesuseugenio@isemu.es
- Phone: +34639238413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.