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Preoperative Massage in Breast Surgery Patients

This study is currently recruiting participants.
Verified August 2012 by Vassar Brothers Medical Center
Sponsor:
Collaborators:
Health Quest Systems
Dyson Center for Cancer Care
Information provided by (Responsible Party):
Vassar Brothers Medical Center
ClinicalTrials.gov Identifier:
NCT01667328
First received: June 14, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Anxiety
Presurgical Anxiety
Breast Cancer
 Procedure: Massage therapy
Procedure: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Utility of Preoperative Massage in Breast Surgery Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vassar Brothers Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Assessments will be done immediately post registration and immediately prior to surgery


Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667328

Contacts
Contact: Erika Mednick 845-483-6456 emednick@health-quest.org
Contact: Kiama Guimaraes 845-483-6304 kguimara@health-quest.org

Locations
United States, New York
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Erika Mednick     845-483-6456     emednick@health-quest.org    
Contact: Kiama Guimaraes     845-483-6304     kguimara@health-quest.org    
Principal Investigator: Angela Keleher, M.D.            
Sub-Investigator: Gregory Zanieski, M.D.            
Sub-Investigator: Sara Winterleitner, N.P.            
Sponsors and Collaborators
Vassar Brothers Medical Center
Health Quest Systems
Dyson Center for Cancer Care
Investigators
Principal Investigator: Angela Keleher, M.D. Vassar Brothers Medical Center
  More Information

Additional Information:
Vassar Brothers Medical Center's Dyson Center for Cancer Care  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vassar Brothers Medical Center
ClinicalTrials.gov Identifier: NCT01667328     History of Changes
Other Study ID Numbers: 2012-2
Study First Received: June 14, 2012
Last Updated: August 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vassar Brothers Medical Center:
Anxiety
Presurgical anxiety
Breast Cancer

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Mental Disorders
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013