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IRCT20190908044729N1 IRCT 2019-09-21 Tehran University of Medical Sciences effect of nature phonics and voice of patient acquaintances on pain and vital criteria in patients with decreased consciousness Comparison the effect of natural voice and family voice on pain and physiological indices in unconscious patients 2019-10-12 anticipated 105 Complete https://irct.ir/trial/42107 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is done in two stages. In the first step, the samples will be included in the study based on inclusion criteria in a continuous method. The second step, namely assigning the samples to the three groups, will be randomized as starting from letter A for the nature sound group, and letter B for the familiar voice group and letter c for the control group. Then write all the permutations of the letters A, B, and C, which are 6 different combinations, on the six cards: 1- ABC 2- ACB 3- BAC 4- BCA 5- CAB 6- CBA Then we ask the nurse number 1 to randomly select a card. For example, if card number 2 is selected, the concept is that the first one is assigned to the voice of nature, the second to the control group, and the third to the familiar voice, and this is continued. Allow the sample size to reach quota, Blinding description: The participants themselves are not randomly assigned to randomization due to reduced level of consciousness. Clinical caregivers (nurses, physicians, physiotherapists, etc.) are not in the process of being randomized. N/A unconscious patients. Intervention 1: Intervention group: family voice, in this intervention, physiological indices such as respiratory rate, heart rate, blood pressure and arterial blood oxygenation were measured using a monitoring device, and the patient's pain level was calculated using the CPOT instrument, and then the familiarity sound A patient who has a closer and more intimate relationship with the voice of a family member (the person whose voice is recorded by family members and chosen by the principal's opinion) and its content including (the individual (family member) after Introduce yourself to the patient, talk about the patient and the patient's location and the reason for their hospitalization. It starts by defining a memory that the patient is expected to be interested in) via the mp3 plyer, using a headphone for 15 minutes, and immediately afterwards physiological indices including respiratory rate, number Heart rate, blood pressure, and arterial blood oxygen are measured using a monitoring device and the patient's pain level is calculated using the CPOT tool. This is done twice in the morning and in the evening for 2 weeks. That is, pain levels and physiological indices were measured daily for 2 weeks before the intervention and also after the intervention in the morning and evening. Intervention 2: Intervention group: natural voice, he Voice of Nature group first measured physiological indices including respiratory rate, heart rate, blood pressure, and arterial blood oxygen level using a monitoring device, and the patient's pain score was calculated using the CPOT instrument. And then the sound of nature (one of the sounds of the Divine) is transmitted to the patient via mp3 plyer using headphones for 15 minutes and immediately thereafter the physiological indices including respiratory rate, heart rate, blood pressure and arterial blood oxygen level. It is measured using a monitoring device and the patient's pain score is calculated using the CPOT tool. This is done twice in the morning and in the evening for 2 weeks. That is, pain levels and physiological indices were measured daily for 2 weeks before the intervention and also after the intervention in the morning and evening. Intervention 3: Control group: Does not receive any 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 No more information
public Kaveh Ebadi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 k-ebadi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mojdeh Navidhamidi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4307 m-navid@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Minimum enrollment age is 18 years Patient with low level of consciousness (Glasgow coma score of 5-9) Lack of hearing (hearing loss) in the person No bandage or ear surgery Lack of paralysis in four organs of the body No hearing aids Pain in the patient based on CPOT instrument (minimum score of 1) 18 years no limit Both -fracture in diseased organs use of neuromuscular blockers high-dose painkillers and sedatives previous history of intensive care unit admission Unstable hemodynamic status R40.2 Coma Other Other Other Intervention group: family voice, in this intervention, physiological indices such as respiratory rate, heart rate, blood pressure and arterial blood oxygenation were measured using a monitoring device, and the patient's pain level was calculated using the CPOT instrument, and then the familiarity sound A patient who has a closer and more intimate relationship with the voice of a family member (the person whose voice is recorded by family members and chosen by the principal's opinion) and its content including (the individual (family member) after Introduce yourself to the patient, talk about the patient and the patient's location and the reason for their hospitalization. It starts by defining a memory that the patient is expected to be interested in) via the mp3 plyer, using a headphone for 15 minutes, and immediately afterwards physiological indices including respiratory rate, number Heart rate, blood pressure, and arterial blood oxygen are measured using a monitoring device and the patient's pain level is calculated using the CPOT tool. This is done twice in the morning and in the evening for 2 weeks. That is, pain levels and physiological indices were measured daily for 2 weeks before the intervention and also after the intervention in the morning and evening. Intervention group: natural voice, he Voice of Nature group first measured physiological indices including respiratory rate, heart rate, blood pressure, and arterial blood oxygen level using a monitoring device, and the patient's pain score was calculated using the CPOT instrument. And then the sound of nature (one of the sounds of the Divine) is transmitted to the patient via mp3 plyer using headphones for 15 minutes and immediately thereafter the physiological indices including respiratory rate, heart rate, blood pressure and arterial blood oxygen level. It is measured using a monitoring device and the patient's pain score is calculated using the CPOT tool. This is done twice in the morning and in the evening for 2 weeks. That is, pain levels and physiological indices were measured daily for 2 weeks before the intervention and also after the intervention in the morning and evening. Control group: Does not receive any intervention Pain: A pain score, which is measured by the CRITICAL-CARE PAIN OBSERVION TOOL criterion, ranging from 0 to 8. Its value is measured before and after the intervention. Timepoint: Immediately before and after the intervention for two weeks in the morning and evening. Method of measurement: CRITICAL-CARE PAIN OBSERVION TOOL Pain Assessment Tool. Physiological indices: Physiological indices in this study are systolic and diastolic blood pressure, mean arterial blood pressure, heart rate, respiratory rate and arterial blood oxygen level, measured by monitoring device before and after intervention in the experimental and control groups. Timepoint: Immediately before and after the intervention for two weeks in the morning and evening. Method of measurement: Cardiovascular Monitoring Machine. Tehran University of Medical Sciences Approved 2019-09-08 Organizational Committee of School of Nursing and Midwifery and Rehabilitation School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN Tehran Tehran Iran (Islamic Republic of)