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Preoperative Massage in Breast Surgery Patients

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ClinicalTrials.gov Identifier: NCT01667328
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Health Quest Systems
Dyson Center for Cancer Care
Information provided by (Responsible Party):
Vassar Brothers Medical Center

Brief Summary:
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 or disease Intervention/treatment
Anxiety Presurgical Anxiety Breast Cancer Procedure: Massage therapy Procedure: Standard of care

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Utility of Preoperative Massage in Breast Surgery Patients
Study Start Date : June 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667328


Contacts
Contact: Carissa Sharp 845-483-6825 csharp1@health-quest.org
Contact: Division of Clinical Research research@health-quest.org

Locations
United States, New York
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Carissa Sharp    845-483-6825    csharp1@health-quest.org   
Contact: Division Of Clinical Research       research@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

Responsible Party: Vassar Brothers Medical Center
ClinicalTrials.gov Identifier: NCT01667328     History of Changes
Other Study ID Numbers: 2012-2
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2016

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders