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Vaginal Massage by Hand or Device to Treat Women with Pain During Sex

Manual or Instrumental Perineal Massage to treat women with Sexual Pain: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2k3zczn
Enrollment
Unknown
Registered
2024-10-02
Start date
2024-12-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

muscle hypertonia

Interventions

This is a randomized, controlled, parallel double-blind clinical trial. 84 women will be randomized into 03 groups with 28 individuals, namely: G1 manual perineal massage which will be the control gro
G2 instrumental perineal massage that will use the Peridell® Therapeutic Massager device
G3 manual perineal massage associated with instrumental perineal massage, where first half of the intervention will be performed with the device and the rest of the service will be done using the hand
E02.190.599

Sponsors

Universidade Federal de Uberlândia
Lead Sponsor
Universidade Federal de Uberlândia
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 18 years; who has already experienced sexual intercourse with vaginal penetration; meets the Diagnostic and Statistical Manual of Mental Disorders criteria for genitopelvic on penetration pain disorder; and has pelvic floor muscles hypertonia verified by vaginal palpation

Exclusion criteria

Exclusion criteria: Women with diagnosed neuromuscular disease will be excluded; pregnant; symptoms of urinary tract infection at the time of assessment; pain triggered after a surgical procedure; already menopausal women; women who cannot tolerate perineal and intravaginal touch; previous trauma or fracture in the pelvic area; neurological or cognitive diseases that hinder or prevent a full understanding of the procedures

Design outcomes

Primary

MeasureTime frame
Assess the intensity of pain reported in two specific situations: a) during attempted vaginal penetration during sexual intercourse, which will be assessed through the participant's self-report and b) pain on palpation in specific points located on the perineal body and vulva ( external regions), which will be evaluated through palpation of the vulva and vagina and the visual analogue scale. It is expected to find a reduction in pain intensity during sexual intercourse, as well as a reduction of at least two points on the visual analogue scale.

Secondary

MeasureTime frame
To evaluate the quality of sexual life using the validated questionnaires Female Sexual Function Index (FSFI) and Sexual Quotient - Female Version (QS-F). We also hope to find a reduction in the tone of the participants' pelvic floor muscles, which will be assessed through digital palpation according to the Tone Scale.

Countries

Brazil

Contacts

Public ContactVanessa Pereira - Baldon

Universidade Federal de Uberlândia

vanessabaldon@ufu.br+553432182901

Outcome results

None listed

Source: REBEC (via WHO ICTRP)