A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope

Allina Health System

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02122796

S121301

Details and patient eligibility

About

The purpose of the study is to compare the effect of acupuncture to the standard of care (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay in post-mastectomy patients at Abbott Northwestern Hospital.

Full description

About 40 subjects will be participating in this study. Following qualification for the study, participants will be randomly assigned by chance to receive either acupuncture or to receive the standard of care without an integrative medicine session.

• One group will receive acupuncture after surgery. Acupuncture involves inserting thin, sterile needles at certain points on your body.
• The other group will receive the standard of care without an acupuncture session.

Before surgery participants will complete a demographics questionnaire. After surgery, participants will be visited in their hospital room by either an acupuncturist or another member of the research team. For those assigned to the acupuncture group, participants will receive up to two sessions of acupuncture, at least twelve hours apart. For those assigned to the control group, a research team member will visit the participant in their room up to two times, at least twelve hours apart. During those visits, participants will be asked about pain, nausea, anxiety, and ability to cope at the beginning and end of each treatment or visit.

Additional information will be gathered from participants hospital charts, such as the type of surgery that was performed, length of hospital stay, and the costs associated with the hospital stay.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women
• 18 years or older
• Undergoing mastectomy surgery

Exclusion criteria

• Non-English speaking
• Pregnant
• Also undergoing an oophorectomy, TRAM or Latissimus flap surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.

Treatment:

Other: Acupuncture

Standard of Care

No Intervention group

Description:

Standard of care post-mastectomy.