Clinical trial NCT02122796: A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope
Official title: A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Mastectomy
Acupuncture
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients Eligible Compared to the Number Approached and Enrolled
timeFrame: One year
Secondary outcomes:
measure: Change in Pain Post Intervention
timeFrame: Participants will be followed on post operations day 1 and 2 of their hospital stay
measure: Change in Anxiety Post Intervention
timeFrame: Participants will be followed on post operations day 1 and 2 of their hospital stay
measure: Change in Nausea Post Intervention
timeFrame: Participants will be followed on post operations day 1 and 2 of their hospital stay
measure: Change in Ability to Cope Post Intervention
timeFrame: Participants will be followed on post operations day 1 and 2 of their hospital stay
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
References: