Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Perineal massage
- Conditions
- Cancer Pain
- Sponsor
- University of Alcala
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Pain (Visual Analoge Scale)
- Status
- Completed
- Last Updated
- yesterday
Overview
Brief Summary
The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis.
The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.
Investigators
Prof. Dr. Daniel Pecos Martín
Professor
University of Alcala
Eligibility Criteria
Inclusion Criteria
- •Women between 18 and 52 years old
- •Oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments.
- •Patients with QT/RT/BT treatment who have a diagnosis of dyspareunia and vaginal stenosis.
- •Patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis.
Exclusion Criteria
- •Patients who do not accept intracavitary treatment.
- •Patients with abdominopelvic surgical treatment prior to oncological process.
- •Patients with a diagnosis of dyspareunia prior to cancer.
- •Patients with vaginal narrowing prior to cancer.
- •Patients with menopause at the time of cancer diagnosis
Arms & Interventions
Perineal massage
Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program.
Intervention: Perineal massage
Treatment with dilators
A health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment.
Intervention: Standard treatment
Outcomes
Primary Outcomes
Pain (Visual Analoge Scale)
Time Frame: Change from baseline at six months
Visual Analogical Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left "0" (worst) to the right "10"(best)
Secondary Outcomes
- Female sexual function index(Change from baseline at six months)
- Criteria for Adverse Events (CTCAE)(Change from baseline at six months)
- Quality of life (EORCT QLQ-C30)(Change from baseline at six months)
- Likert questionnaire by sexual dysfunction(Change from baseline at six months)