Perineal Massage in Women With Gynecological Cancer

NCT ID: NCT06432998

Last Updated: 2025-06-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Pain Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type EXPERIMENTAL

Perineal massage

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Standard treatment

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Daniel Pecos Martín

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Raquel Perez-Garcia

Role: CONTACT

+34 922276912

Facility Contacts

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Raquel Perez-Garcia

Role: primary

+34 922276912

Other Identifiers

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CHUNSC_2023_104

Identifier Type: -

Identifier Source: org_study_id

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