]>
IRCT20100913004736N28 IRCT 2023-12-19 Kermanshah University of Medical Sciences The effect of acupressure on anxiety induced by angiography Investigating the effect of auricular acupressure on anxiety levels and physiological indices of candidates for coronary angiography 2023-12-22 anticipated 120 Complete https://irct.ir/trial/71251 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants will be allocated to two intervention and control groups using random block allocation. Randomization unit: individual Randomization tool: statistical software The blocks will be generated using the software. Allocation concealment: This is a single-blind study, and the participants are unaware of their allocation to the intervention and control groups, Blinding description: To conceal the randomization process, each generated random sequence will be written on a separate card and placed inside opaque envelopes. The order of the sequences will be written on the envelopes. For example, envelope number one may contain the sequence (AABB), and the envelopes will be opened in numerical order. Each envelope will be used until the patients from that particular sequence have been assigned, and then the next envelope will be utilized. N/A Condition 1: Anxiety. Condition 2: Physiologic indexes. Intervention 1: In the intervention group, 30 minutes before angiography, the Shen Men point located in the upper wall of the ear cavity is stimulated bilaterally using a specialized acupressure pen called "Picsor" manufactured in China for a duration of 10 minutes. Intervention 2: In the control group, a sham point located at the outer corner of the ear cavity is used. 30 minutes before angiography, this point is stimulated bilaterally using a specialized acupressure pen called "Picsor" manufactured in China for a duration of 10 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Alireza Khatony
Shahid Beheshti Blvd.,
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3827 9394 akhatony@gmail.com Kermanshah University of Medical Sciences scientific Alireza Khatony
Shahid Beheshti Blvd.,
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3827 9394 akhatony@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Angiography candidate Willingness to participate in the study Having anxiety No history of using acupressure No history of angiography 18 years no limit Both History of psychiatric diseases History of thyroid disease Smoking Cancellation of angiography F41 Other anxiety disorders Treatment - Other Placebo In the intervention group, 30 minutes before angiography, the Shen Men point located in the upper wall of the ear cavity is stimulated bilaterally using a specialized acupressure pen called "Picsor" manufactured in China for a duration of 10 minutes. In the control group, a sham point located at the outer corner of the ear cavity is used. 30 minutes before angiography, this point is stimulated bilaterally using a specialized acupressure pen called "Picsor" manufactured in China for a duration of 10 minutes. Situational anxiety. Timepoint: Thirty minutes before and immediately after the intervention. Method of measurement: To measure anxiety, the State Anxiety Inventory (STAI) questionnaire is used. Blood pressure. Timepoint: Thirty minutes prior to and immediately after the intervention. Method of measurement: The blood pressure measurement is carried out using the Exacta 1350 analog sphygmomanometer made in Germany and the Duplex-4001 medical stethoscope also made in Germany. Prior to blood pressure measurement, the patient should refrain from consuming caffeine (coffee and tea) and smoking for at least thirty minutes. The patient is asked not to speak five minutes before the blood pressure measurement. Then, the patient is positioned in a lying position on their back, comfortably on the bed, with their right arm extended along the side of their body and their palm facing upward. The blood pressure cuff of the mercury sphygmomanometer is then closed approximately 3-2 centimeters above the antecubital fossa of the right arm, and using the stethoscope, the systolic and diastolic blood pressure are measured. This is done by feeling the radial pulse while simultaneously inflating the cuff using the hand pump of the sphygmomanometer. When the pulse is no longer felt, the pressure in the manometer continues to rise until it reaches around 30 millimeters of mercury above the point of pulse disappearance. Then, the cuff is slowly deflated at a rate of 3-2 millimeters of mercury per second, while listening for Korotkoff sounds. The first sound corresponds to the systolic blood pressure. The point at which the sound becomes indistinct or gradually disappears completely represents the diastolic blood pressure. Pulse rate. Timepoint: Thirty minutes prior to and immediately after the intervention. Method of measurement: To measure the pulse rate, the radial artery pulse is counted for one minute. Arterial blood oxygen saturation (SpO2). Timepoint: Thirty minutes prior to and immediately after the intervention. Method of measurement: To measure arterial blood oxygen saturation, the Beurer PO30 fingertip pulse oximeter, made in Germany, is used. For this purpose, the probe of the device is placed on the right index finger for a duration of 10 seconds, and then the value displayed on the monitor is recorded as the arterial blood oxygen saturation level. Respiratory rate. Timepoint: Thirty minutes prior to and immediately after the intervention. Method of measurement: To measure the respiratory rate and chest movements, the number of chest wall movements is counted for one minute simultaneously with the pulse rate measurement. Kermanshah University of Medical Sciences Approved 2023-11-21 Ethics committee of Kermanshah University of Medical Sciences Shahid Beheshti Blvd., Kermanshah Kermanshah Iran (Islamic Republic of)