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Search / Trial NCT06921174

Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain

Launched by INSTITUTO SEXOLÓGICO MURCIANO · Apr 3, 2025

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Postpartum Pelvic Pain

ClinConnect Summary

This clinical trial is studying two different methods to help reduce pain in women who have experienced perineal pain after childbirth. The trial compares traditional perineal massage therapy with the use of a device called “Crescendo 2” that is placed inside the vagina. Women who take part in this study will be randomly assigned to one of the two groups and will have their pain measured before and after treatment using a simple scale.

To be eligible for the trial, women need to be at least 18 years old, live in the Region of Murcia, and have given birth vaginally within the last 6 to 12 months. They should also be experiencing postpartum perineal pain and have not yet received any treatment for it. It's important for participants to be willing to follow the study guidelines. Women with certain serious health conditions or infections will not be able to join. Overall, this study aims to find out which method is more effective in helping to ease the discomfort some women face after giving birth.

Gender

FEMALE

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:
  • -

About Instituto Sexológico Murciano

Instituto Sexológico Murciano is a leading clinical research organization dedicated to advancing the field of sexual health and wellness. With a focus on innovative research methodologies, the institute conducts clinical trials aimed at evaluating new treatments and therapies related to sexual function and reproductive health. Committed to ethical standards and patient-centered care, Instituto Sexológico Murciano collaborates with healthcare professionals and academic institutions to ensure the highest quality of research outcomes. Through its rigorous studies, the institute aims to enhance understanding and improve interventions in sexual health, ultimately contributing to better patient care and quality of life.

Locations

Murcia, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported