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Trial Title:
Perineal Massage in Women With Gynecological Cancer
NCT ID:
NCT06432998
Condition:
Cancer Pain
Neck Cancer
Conditions: Official terms:
Cancer Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Perineal massage
Description:
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.
Arm group label:
Perineal massage
Intervention type:
Other
Intervention name:
Standard treatment
Description:
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.
Arm group label:
Treatment with dilators
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Women diagnosed with vaginal stenosis and dyspareunia due to cancer
Minimum age:
18 Years
Maximum age:
52 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
Address:
City:
Santa cruz de Tenerife.
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Raquel Perez-Garcia
Phone:
+34 922276912
Email:
tenerife@contraelcancer.es
Start date:
May 31, 2024
Completion date:
December 3, 2024
Lead sponsor:
Agency:
University of Alcala
Agency class:
Other
Source:
University of Alcala
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06432998
