Preoperative Massage in Breast Surgery Patients

NCT ID: NCT01667328

Last Updated: 2018-05-03

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

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-03-19

Brief Summary

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This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.

Detailed Description

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Conditions

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Anxiety Presurgical Anxiety Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Massage therapy

This group will received presurgical massage

Group Type EXPERIMENTAL

Massage therapy

Intervention Type PROCEDURE

Presurgical 15 minute massage performed by a licensed massage therapist

Control

Standard of care with no massage

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type PROCEDURE

Control group will receive standard of care with no massage therapy

Interventions

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Massage therapy

Presurgical 15 minute massage performed by a licensed massage therapist

Intervention Type PROCEDURE

Standard of care

Control group will receive standard of care with no massage therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Must speak English
* Able to give consent
* 18 years of age or older
* Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers Medical Center

Exclusion Criteria

* Anxiolytics or antidepressants medications during the previous 24 hours
* Any condition that would prohibit receiving a massage
* IV medications prior to presurgical holding VAS assessment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Quest Systems

UNKNOWN

Sponsor Role collaborator

Dyson Center for Cancer Care

UNKNOWN

Sponsor Role collaborator

Vassar Brothers Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Keleher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vassar Brothers Medical Center

Locations

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Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2012-2

Identifier Type: -

Identifier Source: org_study_id

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