Preoperative anxiety is common among women undergoing surgery for breast cancer and is associated with reduced subjective well-being and adverse perioperative outcomes. Reported sequelae linked to preoperative anxiety include increased postoperative pain, greater incidence of nausea and vomiting, and higher analgesic requirements. Nonpharmacological interventions have shown preliminary promise for stress and symptom reduction, but robust perioperative evaluations in oncology are limited.
The National Acupuncture Detoxification Association (NADA) protocol is a standardized five-point auricular approach that has been investigated for stress-regulating effects in other clinical contexts. However, the NADA protocol has not previously been systematically evaluated in the setting of perioperative therapeutic breast surgery. This trial aims to address that gap by testing whether adding NADA auricular acupressure to routine preoperative care reduces perioperative anxiety and pain in women with a first diagnosis of breast cancer.
The primary objective is to assess the effect of NADA auricular acupressure, administered in addition to standard preoperative care, on preoperative state anxiety prior to therapeutic breast surgery. Secondary objectives include evaluation of postoperative anxiety, perioperative pain (preoperative and postoperative), postoperative nausea and vomiting, analgesic and antiemetic medication use, and postoperative complications. An exploratory objective is to determine whether the intervention influences patients’ initiation or use of other complementary and integrative medicine (CIM) therapies within the first 3 months after surgery.
This is a prospective, two-arm, parallel randomized controlled trial. Sixty-six adult women with a new diagnosis of breast cancer scheduled for therapeutic breast surgery will be enrolled and randomized in a 1:1 ratio to either the experimental arm (NADA auricular acupressure plus standard preoperative care) or the control arm (standard preoperative care alone). The trial is conducted under routine clinical conditions to reflect a real-world perioperative oncology setting.
Eligible participants are adult women with a first diagnosis of breast cancer who are scheduled for therapeutic breast surgery. Recruitment for the trial began in March 2026. At the time the protocol manuscript was submitted, eight participants had been recruited. The authors expect to reach the planned sample size of 66 by April 2027, complete data collection by July 2027, and report results in September 2027.
Participants randomized to the experimental arm will receive the standardized five-point NADA auricular acupressure protocol in addition to the usual preoperative care provided at the study centers. The control arm will receive standard preoperative care alone. The protocol document emphasizes the standardized application of the NADA approach as a methodological strength. Specific details of the exact acupoints, duration, practitioner qualifications, and frequency of application were described in the full protocol publication; those procedural specifics are not restated here beyond the characterization of the intervention as the NADA five-point auricular protocol.
The primary outcome is preoperative state anxiety, measured immediately prior to surgery (timepoint T1) using the State-Trait Anxiety Inventory-State (STAI-S). Secondary outcomes encompass postoperative anxiety, preoperative and postoperative pain, postoperative nausea and vomiting, use of analgesic and antiemetic medications, and postoperative complications. The trial will also capture exploratory data on subsequent CIM use at a 3-month follow-up.
Outcome assessments will be analyzed according to the intention-to-treat principle. The protocol lists planned statistical methods including analysis of covariance for the primary outcome and a combination of linear mixed-effects models, linear regression, and logistic regression for secondary and exploratory outcomes, as appropriate to each endpoint.
The planned sample size is 66 participants randomized 1:1 between intervention and control groups. Randomization procedures are incorporated into the trial design, and analyses will follow an intention-to-treat approach. The primary analysis for preoperative state anxiety will use analysis of covariance. Secondary and longitudinal outcomes will be addressed using linear mixed-effects models or regression methods as appropriate. The protocol indicates appropriate modeling choices but does not report numerical assumptions or power calculations in this abstract; readers should consult the full protocol text for those details.
Recruitment commenced in March 2026. At manuscript submission, eight participants had been enrolled. The authors projected reaching the target sample by April 2027, completing data collection by July 2027, and disseminating results in September 2027.
Key methodological strengths highlighted include the randomized design and the use of a standardized NADA intervention protocol performed in routine clinical conditions, which supports external validity. Important limitations acknowledged by the authors are the absence of participant or provider blinding and the lack of a sham control group, both of which may introduce bias or placebo effects. The trial seeks to generate evidence to inform perioperative supportive care in breast oncology and to guide future research on auricular acupressure interventions in surgical oncology settings.
Keywords associated with the study include NADA protocol, acupressure, acupuncture, anxiety, breast cancer, breast surgery, pain, and randomized clinical trial. The trial is registered and reported as a clinical trial protocol published in JMIR Research Protocols; full protocol details including procedural specifics and statistical assumptions should be consulted in the original publication for implementation or replication purposes.