Back to resultsPreoperative Massage in Breast Surgery Patients
Primary Purpose
Anxiety, Presurgical Anxiety, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage therapy
Standard of care
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring Anxiety, Presurgical anxiety, Breast Cancer
Eligibility 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
Sites / Locations
- Vassar Brothers Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Massage therapy
Control
Arm Description
This group will received presurgical massage
Standard of care with no massage
Outcomes
Primary Outcome Measures
Anxiety level
Assessments will be done immediately post registration and immediately prior to surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT01667328
First Posted
June 14, 2012
Last Updated
April 30, 2018
Sponsor
Vassar Brothers Medical Center
Collaborators
Health Quest Systems, Dyson Center for Cancer Care
1. Study Identification
Unique Protocol Identification Number
NCT01667328
Brief Title
Preoperative Massage in Breast Surgery Patients
Official Title
Utility of Preoperative Massage in Breast Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vassar Brothers Medical Center
Collaborators
Health Quest Systems, Dyson Center for Cancer Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Presurgical Anxiety, Breast Cancer
Keywords
Anxiety, Presurgical anxiety, Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage therapy
Arm Type
Experimental
Arm Description
This group will received presurgical massage
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Standard of care with no massage
Intervention Type
Procedure
Intervention Name(s)
Massage therapy
Intervention Description
Presurgical 15 minute massage performed by a licensed massage therapist
Intervention Type
Procedure
Intervention Name(s)
Standard of care
Intervention Description
Control group will receive standard of care with no massage therapy
Primary Outcome Measure Information:
Title
Anxiety level
Description
Assessments will be done immediately post registration and immediately prior to surgery
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Keleher, M.D.
Organizational Affiliation
Vassar Brothers Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preoperative Massage in Breast Surgery Patients
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