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

• ClinicalTrials.gov Identifier: NCT02122796
• Recruitment Status: Completed
• First Posted: April 25, 2014
• Results First Posted: April 2, 2018
• Last Update Posted: April 2, 2018
• Sponsor: Allina Health System
• Information provided by (Responsible Party): Allina Health System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Other: Acupuncture	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope.
• Study Start Date: June 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture; Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.	Other: Acupuncture; Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.
No Intervention: Standard of Care; Standard of care post-mastectomy.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Eligible Compared to the Number Approached and Enrolled [ Time Frame: One year ]
   Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.

Secondary Outcome Measures :

1. Change in Pain Post Intervention [ Time Frame: Participants will be followed on post operations day 1 and 2 of their hospital stay ]
   Change in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
2. Change in Anxiety Post Intervention [ Time Frame: Participants will be followed on post operations day 1 and 2 of their hospital stay ]
   Change in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
3. Change in Nausea Post Intervention [ Time Frame: Participants will be followed on post operations day 1 and 2 of their hospital stay ]
   Change in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
4. Change in Ability to Cope Post Intervention [ Time Frame: Participants will be followed on post operations day 1 and 2 of their hospital stay ]
   Change in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Sponsors and Collaborators

Allina Health System

More Information

• Responsible Party: Allina Health System
• ClinicalTrials.gov Identifier: NCT02122796
• Other Study ID Numbers: S121301
• First Posted: April 25, 2014
• Results First Posted: April 2, 2018
• Last Update Posted: April 2, 2018
• Last Verified: September 2017

Keywords provided by Allina Health System:

Breast Cancer; Mastectomy; Acupuncture

Additional relevant MeSH terms:

Breast Neoplasms; Nausea; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Signs and Symptoms, Digestive