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

NCT ID: NCT02122796

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.

Standard of Care

Standard of care post-mastectomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

S121301

Identifier Type: -

Identifier Source: org_study_id