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IRCT20220406054435N1 IRCT 2022-06-26 Shiraz University of Medical Sciences The effect of Benson relaxation and back massage on anxiety in angiography patients Investigation the comparative effect of Bensons Relaxation and Back Massage on Anxiety in patients undergoing Coronary Angiography 2022-09-23 anticipated 105 Complete https://irct.ir/trial/62913 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Simple block randomization with block size 6 will be used to place patients in the three groups (massage by the a professional, Benson relaxation technique, and control group). For this purpose, in each block of 6, 2 items will be randomly assigned to the Benson intervention group, 2 items to the massage group and 2 items to the control group. Then, for the next 6 patients, it will be decided randomly in the next block that each patient should be assigned into which group. This process will be proceeded for the next 6 patients until the required number of participants are sampled for the study, Blinding description: Codes assigned to patients in three groups will be kept in sealed envelopes and provided to the ward secretary. Patients will not know about these codes. Moreover, the statistician won't be aware of the participants' group. N/A Cardiac angiography. Intervention 1: Intervention group: Benson relaxation: In this group, before the intervention, vital signs including blood pressure, pulse rate and respiration are measured using the equipment in the ward, the correctness of which has already been checked. The patient is then placed in a quiet, supine position and closed his eyes when the patient's private environment is provided. The patient receives non-verbal music with headphones and tries to relax his muscles from the toes to the head and then relax, and the patient is instructed to try to do this piece by piece and While tightening and relaxing the muscles, visualize them in your mind and breathe through your nose, and while breathing, listen to the breathing sounds and repeat a word. This takes 15 to 20 minutes. Intervention 2: Intervention group: Back massage: Participants will be asked to lie on their backs and unveiled around the bed for patient privacy during the intervention. Also, for male patients, massage will be performed by a male massager and for female patients by a female massager. During the massage, sheets will be stretched on the patient and he will be stripped step by step. The massager, who has already received the necessary training, first warms his hands and soaks them in almond oil. Then massage the back for 20 minutes for the patient. Massage is done by static massage, superficial stretching technique, stretching massage, lymphatic surface emptying technique, transverse rubbing technique, and myofascial release technique, which is performed with efflux (gentle pressure and immersion of the body in oil). Study outcome variables are vital signs (respiration rate, pulse rate and blood pressure) and anxiety, which will be assessed using calibrated devices and the Spielberger Anxiety Inventory. Intervention 3: Control group: No intervention: They will not receive any intervention and will only be provided with routine nursing training. 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 More time to decide
public Seyed Saeid Najafi
Shiraz University of Medical Sciences, Hazrat Fatemeh School of Nursing and Midwifery, Department of Internal Medicine, Surgery and Emergency Medicine
Shiraz Iran (Islamic Republic of) 1978-71345 +98 74 3254 3071 najafisa@yahoo.com Shiraz University of Medical Sciences scientific Seyed Saeid Najafi
Shiraz University of Medical Sciences, Hazrat Fatemeh School of Nursing and Midwifery, Department of Internal Medicine, Surgery and Emergency Medicine
Shiraz Iran (Islamic Republic of) 1978-71345 +98 74 3254 3071 najafisa@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The patient's ability to communicate Be at least 18 years old or older Absence in acute conditions of the disease Do not prohibit touching with a doctor's opinion Only undergo an angiographic plan Do not take drugs, sedatives and alcohol before angiography without a doctor's prescription 18 years no limit Both Hearing problems and muscle paralysis Cognitive and mental disorders Behavior Treatment - Devices N/A Intervention group: Benson relaxation: In this group, before the intervention, vital signs including blood pressure, pulse rate and respiration are measured using the equipment in the ward, the correctness of which has already been checked. The patient is then placed in a quiet, supine position and closed his eyes when the patient's private environment is provided. The patient receives non-verbal music with headphones and tries to relax his muscles from the toes to the head and then relax, and the patient is instructed to try to do this piece by piece and While tightening and relaxing the muscles, visualize them in your mind and breathe through your nose, and while breathing, listen to the breathing sounds and repeat a word. This takes 15 to 20 minutes. Intervention group: Back massage: Participants will be asked to lie on their backs and unveiled around the bed for patient privacy during the intervention. Also, for male patients, massage will be performed by a male massager and for female patients by a female massager. During the massage, sheets will be stretched on the patient and he will be stripped step by step. The massager, who has already received the necessary training, first warms his hands and soaks them in almond oil. Then massage the back for 20 minutes for the patient. Massage is done by static massage, superficial stretching technique, stretching massage, lymphatic surface emptying technique, transverse rubbing technique, and myofascial release technique, which is performed with efflux (gentle pressure and immersion of the body in oil). Study outcome variables are vital signs (respiration rate, pulse rate and blood pressure) and anxiety, which will be assessed using calibrated devices and the Spielberger Anxiety Inventory. Control group: No intervention: They will not receive any intervention and will only be provided with routine nursing training. Anxiety score in Spielberger questionnaire. Timepoint: Measurement of anxiety before the intervention and half an hour after the intervention. Method of measurement: Spielberger Anxiety Questionnaire. Shiraz University of Medical Sciences Approved 2021-12-20 Ethics committee of Shiraz University of Medical Sciences Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)