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IRCT20160110025937N9 IRCT 2025-09-04 Tabriz University of Medical Sciences Effect of Ear Acupressure on Recovery After Heart Surgery in Intensive Care Patients 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 2026-06-20 anticipated 96 Recruiting https://irct.ir/trial/84266 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 1. Participants Blinded: Yes Method: Identical procedures for Intervention (magnetic seeds on specific points) and Placebo (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. N/A Condition 1: anxiety following coronary artery bypass graft (CABG) surgery. Condition 2: acute pain following coronary artery bypass graft (CABG) surgery. Condition 3: Hemodynamic instability following coronary artery bypass graft (CABG) surgery. Condition 4: fatigue following coronary artery bypass graft (CABG) surgery. Condition 5: sleep disturbances following coronary artery bypass graft (CABG) surgery. Condition 6: depression following coronary artery bypass graft (CABG) surgery. Condition 7: delirium following coronary artery bypass graft (CABG) surgery. Intervention 1: Intervention group 1: Participants in this group will receive auricular acupressure. The procedure begins on the second postoperative day. After disinfecting the ear with 70% alcohol, patches containing magnetic seeds will be applied to specific auricular acupressure points (Shenmen, Spleen_c, Small Intestine, Kidney_c, Vagus nerve, Heart_c, Insomnia, San Jiao, and Liver). The researcher will then massage each point with the index finger using circular pressure for 1 minute, aiming to elicit the "Qi" sensation, for a total intervention time of 10 minutes per session. The intervention will be administered twice daily (morning and afternoon) for six consecutive days. To minimize skin irritation, the procedure will be performed on alternating ears each day. Intervention 2: Intervention group 2: Participants in this group will receive a sham acupressure procedure. After disinfecting the ear, magnetic seeds will be applied to non-specific points on the outer part of the ear, away from the true acupressure points. The researcher will then massage each point with the index finger using circular pressure for 1 minute, aiming to elicit the "Qi" sensation, for a total intervention time of 10 minutes per session. The intervention will be administered twice daily (morning and afternoon) for six consecutive days. To minimize skin irritation, the procedure will be performed on alternating ears each day. Intervention 3: Control group: Participants in this group will receive only the standard routine care provided to patients after coronary artery bypass graft surgery. No auricular acupressure or sham procedure will be administered. To ensure temporal consistency with the other groups, participants in the control group will be attended to for a 10-minute period at the same scheduled times, but no intervention will be performed. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: Data will be made available to qualified researchers affiliated with academic and research institutions. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Aefeh Allahbakhshian
Tabriz University of Medical Sciences, Golgasht Avenue
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 atefehbakhshian@gmail.com Tabriz University of Medical Sciences scientific Aefeh Allahbakhshian
Tabriz University of Medical Sciences, Golgasht Avenue
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 atefehbakhshian@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 years. No prior history of coronary artery bypass surgery. Undergoing non-emergency coronary artery bypass surgery. Uniform anesthesiologist and anesthesia conditions for the patient. Surgery performed using a heart-lung machine. No history of psychological disorders (e.g., depression or major anxiety disorder) and no use of psychotropic medications No auricular acupressure received in at least the past 5 months. No intra-aortic balloon pump or pacemaker. No addiction to alcohol or drugs. No history of chronic pain (e.g., severe arthritis). Healthy external ear structure without abnormalities. Not concurrently participating in a similar study. 18 years 70 years Both Impaired consciousness (GCS score less than 15). Inability to communicate or understand instructions. Patient's statement of unwillingness to participate in the intervention. F06.4 G89.18 F51 F05 Anxiety disorder due to known physiological condition Other acute postprocedural pain FATIGUE Sleep disorders not due to a substance or known physiological condition Delirium due to known physiological condition Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Participants in this group will receive auricular acupressure. The procedure begins on the second postoperative day. After disinfecting the ear with 70% alcohol, patches containing magnetic seeds will be applied to specific auricular acupressure points (Shenmen, Spleen_c, Small Intestine, Kidney_c, Vagus nerve, Heart_c, Insomnia, San Jiao, and Liver). The researcher will then massage each point with the index finger using circular pressure for 1 minute, aiming to elicit the "Qi" sensation, for a total intervention time of 10 minutes per session. The intervention will be administered twice daily (morning and afternoon) for six consecutive days. To minimize skin irritation, the procedure will be performed on alternating ears each day. Intervention group 2: Participants in this group will receive a sham acupressure procedure. After disinfecting the ear, magnetic seeds will be applied to non-specific points on the outer part of the ear, away from the true acupressure points. The researcher will then massage each point with the index finger using circular pressure for 1 minute, aiming to elicit the "Qi" sensation, for a total intervention time of 10 minutes per session. The intervention will be administered twice daily (morning and afternoon) for six consecutive days. To minimize skin irritation, the procedure will be performed on alternating ears each day. Control group: Participants in this group will receive only the standard routine care provided to patients after coronary artery bypass graft surgery. No auricular acupressure or sham procedure will be administered. To ensure temporal consistency with the other groups, participants in the control group will be attended to for a 10-minute period at the same scheduled times, but no intervention will be performed. Level of anxiety. Timepoint: Before surgery (baseline), at the time of transfer from the intensive care unit to the general surgical ward (the third day after surgery and the second day of receiving the intervention), at the time of hospital discharge (the seventh day after surgery and the sixth day of receiving the intervention), and one month after discharge (one month after the completion of the intervention). Method of measurement: The Hospital Anxiety and Depression Scale (HADS) questionnaire. Pain intensity. Timepoint: From the second postoperative day, measurements will be taken before and immediately after each intervention session (twice daily for 6 days). Method of measurement: Visual Analogue Scale (VAS). Depression level. Timepoint: Before surgery (baseline), at the time of transfer from the intensive care unit to the general surgical ward (the third day after surgery and the second day of receiving the intervention), at the time of hospital discharge (the seventh day after surgery and the sixth day of receiving the intervention), and one month after discharge (one month after the completion of the intervention). Method of measurement: The Hospital Anxiety and Depression Scale (HADS) questionnaire. Severity of fatigue. Timepoint: Before surgery (baseline), at the time of transfer from the intensive care unit to the general surgical ward (the third day after surgery and the second day of receiving the intervention), at the time of hospital discharge (the seventh day after surgery and the sixth day of receiving the intervention), and one month after discharge (one month after the completion of the intervention). Method of measurement: Multidimensional Fatigue Inventory (MFI) questionnaire. Sleep quality. Timepoint: Before surgery (baseline), at the time of transfer from the intensive care unit to the general surgical ward (the third day after surgery and the second day of receiving the intervention), at the time of hospital discharge (the seventh day after surgery and the sixth day of receiving the intervention), and one month after discharge (one month after the completion of the intervention). Method of measurement: Richards-Campbell Sleep Questionnaire in ICU and Pittsburgh Sleep Quality Index (PSQI) questionnaire. Heart rate. Timepoint: From the second postoperative day, measurements will be taken before and immediately after each intervention session (twice daily for 6 days). Method of measurement: Cardiac monitoring device. Respiratory rate. Timepoint: From the second postoperative day, measurements will be taken before and immediately after each intervention session (twice daily for 6 days). Method of measurement: direct observation. Body temperature. Timepoint: From the second postoperative day, measurements will be taken before and immediately after each intervention session (twice daily for 6 days). Method of measurement: Standard clinical thermometer. Systolic blood pressure. Timepoint: From the second postoperative day, measurements will be taken before and immediately after each intervention session (twice daily for 6 days). Method of measurement: Cardiac monitoring device. Diastolic blood pressure. Timepoint: From the second postoperative day, measurements will be taken before and immediately after each intervention session (twice daily for 6 days). Method of measurement: Cardiac monitoring device. Delirium. Timepoint: Before surgery (baseline), at the time of transfer from the intensive care unit to the general surgical ward (the third day after surgery and the second day of receiving the intervention), at the time of hospital discharge (the seventh day after surgery and the sixth day of receiving the intervention), and one month after discharge (one month after the completion of the intervention). Method of measurement: Confusion Assessment Method (CAM)-ICU-7 delirium severity scale. Tabriz University of Medical Sciences Approved 2025-06-02 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht ave., Tabriz, Iran tabriz East Azarbaijan Iran (Islamic Republic of)