Preoperative Massage in Breast Surgery Patients

April 30, 2018 updated by: Vassar Brothers Medical Center

Utility of Preoperative Massage in Breast Surgery Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Vassar Brothers Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage therapy
This group will received presurgical massage
Procedure: Massage therapy
Presurgical 15 minute massage performed by a licensed massage therapist
Placebo Comparator: Control
Standard of care with no massage
Procedure: Standard of care
Control group will receive standard of care with no massage therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.
Assessments will be done immediately post registration and immediately prior to surgery
Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vassar Brothers Medical Center

Collaborators

Health Quest Systems
Dyson Center for Cancer Care

Investigators

  • Principal Investigator: Angela Keleher, M.D., Vassar Brothers Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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