The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery
- Conditions
- Acupuncture TherapyBreast Neoplasms
- Interventions
- Other: Acupuncture
- Registration Number
- NCT04608175
- Lead Sponsor
- University Ramon Llull
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- Diagnosis of breast cancer
- Primary breast cancer patient
- Candidate for breast cancer surgery (mastectomy)
- Aged between 20 and 70 years old
- Consenting to participate in the study and signing the informed consent form.
- Have a previous history of breast cancer
- Have a previous diagnosis of a severe psychiatric disorder
- Present risk factors associated with breast cancer
- Do not speak Spanish or Catalan
- Are currently participating in another trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture group Acupuncture The experimental group will receive the standard treatment administered in these cases (analgesic regimen and nursing care procedures), in addition to the following acupuncture therapy. In the first visit (preoperative), the anamnesis and energy diagnosis of each patient will be carried out following the practices of Traditional Chinese Medicine (TCM) to design a personalized treatment based on the patient's medical history. A treatment of approximately 10 to 12 acupuncture points will be designed considering the TCM diagnosis and medical history of each patient. Both TCM diagnosis and the points used will be reassessed in each session. The points belonging to the upper extremity of the affected breast will be treated on the contralateral side, taking care not to insert any needle in the limb on the affected side. No points in the operated region will be used.
- Primary Outcome Measures
Name Time Method Post-intervention pain at 12 hours after surgery 12 hours after surgery (before the acupuncture treatment) 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.
Analgesic compsumption at home From discharge until day 15 after surgery. Amount of analgesic medication administered (ex: mg)
Analgesic compsumption during hospital stay During the hospital stay Amount of analgesic medication administered (ex: mg)
Post-intervention pain at first out-patient visit In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session) 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.
Post-intervention pain at 48 hours after surgery 48 hours after surgery (after the acupuncture treatment) 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.
- Secondary Outcome Measures
Name Time Method Post-operative complications Up to one month. Post-operative complications such as seroma, infection and wound healing will be recorded.
Postoperative nausea after surgery At 12 hours after surgery The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)
Postoperative nausea at 24-48 hours At 24-48 hours after surgery The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)
Acupuncture adverse events Up to one month. Adverse events possibly linked to acupuncture such as pain, hematomas etc. will be recorded.
Anxiety at 12 hours Evaluations will be made 12 hours after the intervention 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.
Anxiety at 48 hours Evaluations will be made 48 hours after the intervention 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.
Anxiety at one month Evaluations will be made at one month after surgery. 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.
Anxiety at first visit Evaluations will be made at first visit, between 10 and 12 days after the intervention. 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