We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Massage in Breast Surgery Patients

This study is currently recruiting participants.
Verified May 2016 by Vassar Brothers Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667328
First Posted: August 17, 2012
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Health Quest Systems
Dyson Center for Cancer Care
Information provided by (Responsible Party):
Vassar Brothers Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Utility of Preoperative Massage in Breast Surgery Patients

Resource links provided by NLM:


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. ]
    Assessments will be done immediately post registration and immediately prior to surgery


Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Vassar Brothers Medical Center
ClinicalTrials.gov Identifier: NCT01667328     History of Changes
Other Study ID Numbers: 2012-2
First Submitted: June 14, 2012
First Posted: August 17, 2012
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