Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy. Methods: This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain). A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications. Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Treatment of disease by inserting needles along specific pathways or meridians. The placement varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.
Post-intervention pain at 12 hours after surgery
Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.
Time frame: 12 hours after surgery (before the acupuncture treatment)
Post-intervention pain at 48 hours after surgery
Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.
Time frame: 48 hours after surgery (after the acupuncture treatment)
Post-intervention pain at first out-patient visit
Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.
Time frame: In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session)
Analgesic compsumption during hospital stay
Amount of analgesic medication administered (ex: mg)
Time frame: During the hospital stay
Analgesic compsumption at home
Amount of analgesic medication administered (ex: mg)
Time frame: From discharge until day 15 after surgery.
Anxiety at 12 hours
Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition.
Time frame: Evaluations will be made 12 hours after the intervention
Anxiety at 48 hours
Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition.
Time frame: Evaluations will be made 48 hours after the intervention
Anxiety at first visit
Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition
Time frame: Evaluations will be made at first visit, between 10 and 12 days after the intervention.
Anxiety at one month
Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition.
Time frame: Evaluations will be made at one month after surgery.
Postoperative nausea after surgery
The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)
Time frame: At 12 hours after surgery
Postoperative nausea at 24-48 hours
The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)
Time frame: At 24-48 hours after surgery
Post-operative complications
Post-operative complications such as seroma, infection and wound healing will be recorded.
Time frame: Up to one month.
Acupuncture adverse events
Adverse events possibly linked to acupuncture such as pain, hematomas etc. will be recorded.
Time frame: Up to one month.
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