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IRCT20190328043132N1 IRCT 2019-04-23 Mazandaran University of Medical Sciences Comparing the effect of eye mask and self selected music on the level of anxietyand hemodynamic indices in patients undergoing cardiac angiography Comparing the effect of eye mask and self selected music on the level of anxietyand hemodynamic indices in patients undergoing cardiac angiography 2018-12-21 anticipated 360 Complete https://irct.ir/trial/38661 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples are selected by random method and will be randomly divided into four groups.Group A (eye mask ),Group B (self selected music) Group C (Receiver of self Selected Music and eye mask at the same time) And group D (control group).The design of this research is in the form of parallel groups, In this case, a comparison is made between the two randomly assigned groups.One group faces certain treatment and the other group is not faced.Participants in the study period remain in the examined and control groups.The necessity of the third group in this study (Receiver of self Selected Music and eye mask at the same time) is based on a clinical trial with factorial designs.So that they compare the two therapies simultaneously with the control group, and the third group will receive both treatments to examine the interference effects of the two treatments.The random allocation of patients in each of the four groups is performed using random block and all random variables are used to create the block.The random allocation of patients in each of the four groups is performed using random block and all random variables are used to create the block. Each block is assigned a number from 1 to 24 and These numbers are placed in the pieces of the cases for selection, and according to the sample size, N times randomly selected a nut, and again the vertebrae is returned to the lottery cycle to complete the number of members of the groups To make, Blinding description: Blinding in this study is as follows: An assessment that completes the anxiety questionnaire before and after the intervention, and the statistician who studies the results is unaware of the process of doing the research (blinded) This knowledge, while the researcher is aware of the type of intervention devoted to the participants in the research, does not affect the analysis of the data. N/A Coronary artery disease. Intervention 1: Intervention group: A(eye mask). Intervention 2: Intervention group: B( self selected music). Intervention 3: Intervention group: C( eye mask and self selected music at the same time). Intervention 4: Control group: whit out intervention. 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 After the end of the study, the conclusion and the final analysis will be published.
public Jafary Hedayat
Nasibe Faculty of Nursing and Midwifery,Vesal Street,Amir Mazandarani Blvd
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7342 hjafari@mazums.com Mazandaran University of Medical Sciences scientific Sanaz Esfandiary
Nassibe Faculty of Nursing and Midwifery, Vesal Street, Amir Mazandarani Blvd
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 8916 esfandiary_sanaz69@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 and above. Patient is alert and able to verbal communication and eye contact, Candidate for coronary artery angiography, Earning score above 32 after responding to the Spielberger state-trait anxiety inventory, willingness to participate in the study, Desire to hear music, Allow physician to play music,Tendency to close the eye. No drug consuming for four hours and soothing at least one hour before the intervention, Non-use of antipsychotics, Lack of cognitive impairment,  The absence of significant visual and auditory problems 18 years no limit Both Pregnancy. The presence of acute pain in the part of the body,  Uneducated and very low literacy patients, Patients with angiography history,  Get an anxiety score of 73 up, Emergency Angiography , Medical personnel. Other Other Other Other Intervention group: A(eye mask) Intervention group: B( self selected music) Intervention group: C( eye mask and self selected music at the same time) Control group: whit out intervention The percent of people who have a Spielberger anxiety scores above 32. Timepoint: Anxiety levels 10 minutes before intervention and 20 minutes after intervention. Method of measurement: Spielberger State Trait Anxiety Inventory. Hemodynamic indices(blood pressure, hear rate, respiratory rate). Timepoint: Immediately before, immediately after placement on the angiographic bed and 5 minutes after the intervention and immediately after the doctor completes the work, and 20 minutes after the end of the intervention. Method of measurement: Poyandegan Rah Saadat monitor digital and cuff pressure meter to it. Mazandaran University of Medical Sciences Approved 2018-12-11 Ethics Committee of Mazandaran University of Medical Sciences Nasibeh Nursing College, Vesal street,Amir Mazandarani Blv sari Mazandaran Iran (Islamic Republic of)