The effect of auriculotherapy on the level of situational anxiety and heart-focused anxiety of candidates for angiography

Evaluating the efficacy of auriculotherapy on situational and heart-focused anxiety in angiography candidates

Phase III double-blind randomized sham-controlled trial with parallel groups on 138 patients, randomization performed using a randomization table generated by the Random Allocation software

This study will be performed on 138 angiography candidates admitted to the CCU and post-CCU wards of Shahid Mohammadi hospital, BandarAbbas. Patients will be randomized into two groups based on a randomization table. In the intervention group, one hour before angiography, auriculotherapy will be performed with thumb and a plastic bead using mild pressure for 10 min on the Shenmen point in the non-dominant ear, and in the control group, one hour before angiography, acupressure will be performed on a false point and not the main point for 10 min in the non-dominant ear. The main outcome (anxiety) evaluation is done by patients, and the physiological indicators by the resrearcher, who are blinded to groupings, resulting in a double-blind research.

Inclusion criteria: Age of 18 years or older, literacy, candidacy for coronary angiography Exclusion criteria: Simultaneous participation in other interventional research projects, having participated in anxiety management educational courses, drug or alcohol abuse, taking anti-psychotic medications, structural disorders of the external ear, previous angiography, cognitive or psychiatric disorders

Intervention group: One hour before angiography, auriculotherapy with thumb and a plastic bead using mild pressure for 10 min on the Shenmen point in the non-dominant ear Control group: One hour before angiography, acupressure on a false point and not the main point for 10 min in the non-dominant ear

Anxiety

Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. An individual uninvolved in the study will write A or B on a card and put it in an opaque envelope. Then the associated number in the randomization table will be written on the back of the envelope. One envelope will be allocated to each patient in order of entrance to the study. Allocation concealment will be done using opaque envelopes.

In the control group, the pressure will be on the false points and the patients will receive the interventions independently of each other and in the order of entering the study. The evaluation of the main outcome, i.e. anxiety, is done by the patient himself, who will be unaware of the grouping, and the evaluation of the physiological indicators is done by the researcher, who is not aware of the grouping of the patients. Therefore, both the participants and the evaluator will be blinded and the study will be conducted in a double-blind manner.

There is no further information.