The Effect of Auricular Acupressure on Some Physical and Psychological Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery Admitted to the Cardiac Intensive Care Unit: A Randomized Single-Blind Clinical Trial

To evaluate auricular acupressure versus sham acupressure or control on anxiety, pain, depression, physiological parameters (blood pressure, heart rate, respiratory rate), fatigue, sleep quality and delirium in elective coronary artery bypass grafting patients admitted to cardiac intensive care unit.

Randomized single-blind sham-controlled three-arm parallel trial. N=96 (32/group). Stratified block randomization (age/gender/pre-op anxiety). Single-center.

Patients undergoing coronary artery bypass graft surgery admitted to the cardiac intensive care unit of Shahid Madani Hospital, Tabriz, who meet the inclusion criteria and provide informed consent, will be randomly assigned (1:1:1) to intervention (auricular acupressure), placebo, or control groups. This single-blind study will be conducted by an independent blinded analyst.

Inclusion: Age between 18 and 70 years, No prior history of coronary artery bypass surgery, Undergoing non-emergency coronary artery bypass surgery, Healthy external ear structure without abnormalities, Not concurrently participating in a similar study. Exclusion: Impaired consciousness (GCS score less than 15), Inability to communicate or understand instructions, Patient's statement of unwillingness to participate in the intervention.

Intervention: Magnetic seeds at 10 auricular points; applied twice daily × 6 days (post-op day 2 onward). Sham: Identical non-magnetic seeds at non-acupoint sites; same frequency/duration. Control: Routine care only.

Anxiety, depression, Pain intensity, Physiological parameters (blood pressure, heart rate, respiratory rate), Fatigue, Sleep quality, delirium

Due to the fact that a significant proportion of patients undergoing non-emergency coronary artery bypass graft (CABG) surgery at Shahid Madani Hospital in Tabriz are over 65 years old, the age inclusion criterion was changed from 18–65 years to 18–70 years. Furthermore, considering their greater clinical importance, the primary outcomes of the study were focused on pain, anxiety, and depression. This change resulted in the adjustment of the required sample size to 96 participants. In the measurement tools section, in addition to the Pittsburgh Sleep Quality Index (PSQI) which evaluates sleep changes over the past month, the Richards-Campbell Sleep Questionnaire was also added. This allows for the assessment of sleep changes in patients during their ICU stay and enables evaluation of both the short-term and long-term effects of the intervention on sleep outcomes. With the expansion of the age range, the secondary outcomes of the study were also broadened, and delirium was added to the secondary outcomes. In addition, the description of the sham group intervention was modified so that the magnetic beads are removed from the center of the patches to increase similarity to the placebo.

Block randomization with a block size of 6 and 3 (to ensure balanced group allocation: 2 intervention, 2 placebo, 2 control per block or 1 intervention, 1 placebo, 1 control per block). Unit of Randomization: Individual patients. Randomization Strata: Stratification by: Age (≤60 years vs. >60 years) Gender (male vs. female) Preoperative anxiety score (HADS score ≤10 vs. >10). Tools Used: Random sequence generation: Random Allocation Software (RAS) version 2.0. Allocation concealment: Sequentially numbered, opaque, sealed envelopes (SNOSE). Random Sequence Building: An independent researcher generated the random sequence using RAS with a 1:1:1 allocation ratio. The sequence accounted for stratification factors (age, gender, anxiety). Assignments were printed, sealed in envelopes, and stored securely. Allocation Concealment: Yes, implemented via SNOSE. Envelopes were opened after patient enrollment and baseline assessments by a research nurse uninvolved in recruitment.

1. Participants Blinded: Yes Method: Identical procedures for Intervention (real acupressure seeds on specific points) and Placebo (patches without magnetic seeds on non-specific ear areas). Both groups receive "ear seed application" with identical appearance/duration (10 mins/session). Control group receives no ear contact to avoid inadvertent unblinding. 2. Intervention Providers Blinded: No Reason: Providers must apply seeds to specific vs. non-specific points, making blinding impossible. 3. Outcome Assessors Blinded: Yes Method: Assessors (data collectors) are separate from intervention providers. Use coded IDs (e.g., Group A/B/C) during data collection (anxiety, pain, physiological parameters). Prohibited from entering ICU during intervention sessions. 4. Principal Investigator (PI) Blinded: Partially Method: PI oversees trial but does not perform randomization, interventions, or outcome assessments. Unblinded only for adverse event monitoring. 5. Healthcare Providers Blinded: No Reason: Routine care may involve observing ear seeds, but they are instructed not to discuss group allocation with patients/assessors. 6. Data Analysts Blinded: Yes Method: Analyze anonymized datasets labeled as "Group A/B/C" without decoding until final analysis. 7. Data Safety Monitoring Board (DSMB) Blinded: No Reason: DSMB requires unblinded data for safety oversight. 8. Manuscript Writers Blinded: Yes until analysis completion Method: Writers receive blinded results initially; unblinding occurs during interpretation.

Deidentified Individual Participant Data (IPD): The shared dataset will include all collected deidentified IPD for each participant, covering demographic and clinical baseline characteristics, group allocation, and all primary and secondary outcome variables (HADS, VAS, MFI, PSQI, and physiological parameters) at all measurement timepoints as described in the protocol. Study Protocol: The final version of the study protocol as approved by the ethics committee. Statistical Analysis Plan (SAP): The detailed plan for the statistical analysis of the study data.

The data will become available 6 months after the publication of the main trial results and will remain available for a period of 5 years.

Data will be made available to qualified researchers affiliated with academic and research institutions.

Access to the data will be granted for the purpose of re-analysis, meta-analysis, or other methodologically sound research. Requesters must submit a formal research proposal detailing the study's objectives, methodology, and analysis plan. All requests will be reviewed by the principal investigator to ensure the scientific validity and ethical soundness of the proposed use. Upon approval, the requester will be required to sign a data access agreement committing to protect participant confidentiality and use the data only for the approved purpose.

Interested researchers can obtain the data by sending a formal request via email to the principal investigator: * Contact Person: Atefeh Allah Bakhshian * Email: atefehbakhshian@gmail.com

The process for accessing the data involves the following steps: * The applicant must submit a formal request via email to the principal investigator, including a detailed research proposal. * The request and proposal will be reviewed by the principal investigator and the research team, a process which may take up to 30 days. * If the request is approved, a data access agreement will be sent to the applicant. * The applicant must sign and return the data access agreement. * Upon receipt of the signed agreement, the deidentified individual participant dataset and relevant documents will be securely transferred to the applicant.