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NCT Number: NCT06921174

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Sexológico Murciano

Murcia, 30007, Spain

Location status: Recruiting

Location contact

Monica Sosa Cabrera, MSc

CONTACT

[email protected]

+34685131637

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Use of the "Crescendo 2" Intravaginal Device

Device

Self-administered perineal massage at home with Crescendo device.

Three times per week, 10 minutes each session, over a 12-week period.

Classical Perineal Massage Therapy

Procedure

Performed manually by a pelvic floor physiotherapist.

One 30-minute session per week for 12 weeks.

Primary outcomes

  1. Visual Analogue Scale (VAS) - to assess pain intensity

    Time frame: First measure week 1 and Last measure week 12

    The **Visual Analogue Scale (VAS)** will be used as the **primary outcome measure**. It consists of a horizontal line approximately 10 centimeters long. At each end of the line are the extreme expressions of pain: on the left, "no pain," and on the right, "worst imaginable pain." This tool allows us to measure the intensity of pain with high reproducibility between observers.

    Visual Analogue Scale (VAS):

    The Visual Analogue Scale is a psychometric response scale used to measure pain intensity. It typically consists of a 10-centimeter horizontal line anchored by two verbal descriptors: "no pain" (score = 0) and "worst imaginable pain" (score = 10).

    Minimum score: 0 (no pain) Maximum score: 10 (worst imaginable pain) Interpretation: Higher scores indicate worse outcomes (i.e., more intense pain).

Secondary outcomes

  1. Clinical Global Impression (CGI) - for overall health status

    Time frame: At the end of the treatment week 12

    The Clinical Global Impression Scale (CGI) will be used as the secondary outcome measure.

    The Global Impression Scale (GIC) is a subjective tool used to assess the overall perceived change in a patient's health status, particularly in clinical studies involving various conditions and treatments.

    Clinical Global Impression - Change (CGI-C) Scale:

    The Clinical Global Impression - Change scale is a clinician-rated tool used to assess changes in a patient's condition over time, relative to baseline.

    Minimum score: 1 (very much improved) Maximum score: 7 (very much worse) Interpretation: Lower scores indicate better outcomes (i.e., greater clinical improvement), while higher scores indicate worsening.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesús Eugenio Dr. Rodríguez Martínez, Phd

CONTACT

[email protected]

+34639238413

Sponsors and collaborators

Lead sponsor

Instituto Sexológico Murciano

Other

Collaborators

  • CIAGO - Center for Comprehensive Gynecology and Obstetrics
  • Carmen Parra Pilates Center

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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