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Completed

NCT Number: NCT02122796

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Apr 25, 2014
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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