Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2024-05-31
2025-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Perineal massage
Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program.
Perineal massage
The technique will be applied for approximately twenty minutes and will be carried out as follows: the vaginal dilator is introduced progressively using crescent-shaped movements. Once the dilator is fully inserted, movements will be made from bottom to top and from one side to the other, and then continue with the crescent-shaped movements.
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.
Standard treatment
The treatment will consist of the use of vaginal dilators according to the gold standard proposed in the literature. It will consist of introducing the same dilators as for the experimental group, with the same time schedule, but without massage, only introducing the dilator and keeping it in the vagina for 20 minutes.
Interventions
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Perineal massage
The technique will be applied for approximately twenty minutes and will be carried out as follows: the vaginal dilator is introduced progressively using crescent-shaped movements. Once the dilator is fully inserted, movements will be made from bottom to top and from one side to the other, and then continue with the crescent-shaped movements.
Standard treatment
The treatment will consist of the use of vaginal dilators according to the gold standard proposed in the literature. It will consist of introducing the same dilators as for the experimental group, with the same time schedule, but without massage, only introducing the dilator and keeping it in the vagina for 20 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
52 Years
FEMALE
No
Sponsors
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University of Alcala
OTHER
Responsible Party
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Prof. Dr. Daniel Pecos Martín
Professor
Principal Investigators
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Raquel Perez-García
Role: PRINCIPAL_INVESTIGATOR
Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
Locations
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Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
Santa Cruz de Tenerife, Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUNSC_2023_104
Identifier Type: -
Identifier Source: org_study_id
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