Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain (Visual Analoge Scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Perineal massage
Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program.
干预措施: Perineal massage (Other)
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.
干预措施: Standard treatment (Other)
结局指标
主要结局
Pain (Visual Analoge Scale)
时间窗: 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)
次要结局
- 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)
研究者
Prof. Dr. Daniel Pecos Martín
Professor
University of Alcala