Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer

NCT ID: NCT03415230

Last Updated: 2019-01-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-01-09

Brief Summary

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This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.

Detailed Description

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The period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. This can often trigger increased anxiety levels and sleep disturbances. This trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.

Conditions

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Sleep Disturbance Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
therapeutic massage vs sham massage

Study Groups

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Therapeutic massage

Women will undertake sessions of therapeutic massage

Group Type EXPERIMENTAL

Therapeutic massage

Intervention Type OTHER

Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.

Sham massage

Women will undertake sessions of sham massage

Group Type SHAM_COMPARATOR

Sham massage

Intervention Type OTHER

Sham massage involves only light touch massage in a non systematic way

Interventions

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Therapeutic massage

Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.

Intervention Type OTHER

Sham massage

Sham massage involves only light touch massage in a non systematic way

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women that completed their treatment
* women experiencing insomnia
* women experiencing anxiety
* women that speak and understand Greek

Exclusion Criteria

* allergy to essential oils
* use of anticoagulants
* presence of edema
* presence of Varicose veins
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cyprus Anticancer Society

UNKNOWN

Sponsor Role collaborator

Cyprus University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andreas Charalambous

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Charalambous, PhD

Role: PRINCIPAL_INVESTIGATOR

Cyprus University of Technology

Locations

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Oncology Centre

Nicosia, , Cyprus

Site Status

Countries

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Cyprus

Other Identifiers

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AC-TMSQ-2018

Identifier Type: -

Identifier Source: org_study_id

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