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Clinical Trials/NCT01667328
NCT01667328
Completed
Not Applicable

Utility of Preoperative Massage in Breast Surgery Patients

Vassar Brothers Medical Center1 site in 1 country299 target enrollmentStarted: June 2012Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
299
Locations
1
Primary Endpoint
Anxiety level

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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