Preoperative Massage in Breast Surgery Patients

Breast Cancer Clinical Trial

Official title:

Utility of Preoperative Massage in Breast Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667328
• Other study ID #: 2012-2
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 19, 2018

Study information

• Verified date: April 2018
• Source: Vassar Brothers Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: March 19, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Breast Cancer
• Presurgical Anxiety

Intervention

Procedure:
• Massage therapy
Presurgical 15 minute massage performed by a licensed massage therapist
• Standard of care
Control group will receive standard of care with no massage therapy

Locations

Country	Name	City	State
United States	Vassar Brothers Medical Center	Poughkeepsie	New York

Sponsors (3)

Lead Sponsor	Collaborator
Vassar Brothers Medical Center	Dyson Center for Cancer Care, Health Quest Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level	Assessments will be done immediately post registration and immediately prior to surgery	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.

External Links

•   Vassar Brothers Medical Center's Dyson Center for Cancer Care