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IRCT20220620055234N1 IRCT 2023-04-28 Kermanshah University of Medical Sciences Examining auditory distraction and virtual reality distraction on pain, comfort, anxiety and physiological parameters of burn patients Comparison of the effect of auditory distraction and virtual reality distraction on pain, comfort, anxiety and physiological parameters during dressing change in burn patients 2023-06-04 anticipated 60 Complete https://irct.ir/trial/69580 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be placed in two intervention groups and one control group by minimization method or matched randomization based on auxiliary variables. In this method, the first person will be randomly assigned to one of the groups, and the next people will be assigned to the group that has the least number of desired characteristics based on the degree of burn variable. This type of randomization method can be easily managed using minim software. The sequence of random allocation is done by the statistical consultant. Registration of people and their allocation to interventions will be done by the researcher. N/A Burn Patients. Intervention 1: The first intervention group: the auditory distraction group, in which the samples will listen to a combination of no lyric music and the sounds of nature with headphone while changing the dressing until the end, immediately after taking a shower. Intervention 2: The second intervention group: the virtual reality group, in which the samples will see images of the cosmos and nature during the dressing change until the end ,by using a virtual reality headset, immediately after taking a shower. Intervention 3: Control group: Dressing will be changed as usual without any intervention. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identification. When: The access period starts 3 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Analysis is allowed on the delivered data Where to obtain: Through the researcher's email address : khatere.soori@kums.ac.ir How to obtain: First, the reason for requesting the data and introducing your resume and a full explanation about the possible use of the data should be emailed. Then the email will be answered within 1 month. Comments:
public Khatere Soori
Dovlat abad
Kermanshah Iran (Islamic Republic of) 6714869914 +98 991 049 1951 khatere.soori@kums.ac.ir Kermanshah University of Medical Sciences scientific Khatere Soori
Dovlat abad
Kermanshah Iran (Islamic Republic of) 6714869914 +98 991 049 1951 khatere.soori@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age 15 to 60 years Not having speech, vision, hearing disorders Not having mental retardation Not having neurological defects such as (limb neuropathy, limb paralysis) Patient consent and willingness to cooperate The burn level is 5-50 percent in the body based on the doctor's diagnosis. Second and third degree burns based on doctor's diagnosis Hospitalization day 2-3 Not having pain before dressing change 15 years 60 years Both Unwillingness to participate in the study Emergency conditions such as cardiopulmonary resuscitation or seizures History of drug abuse Self-immolation patients who have psychiatric problems Burns in the eyes and ears Other Other Other The first intervention group: the auditory distraction group, in which the samples will listen to a combination of no lyric music and the sounds of nature with headphone while changing the dressing until the end, immediately after taking a shower. The second intervention group: the virtual reality group, in which the samples will see images of the cosmos and nature during the dressing change until the end ,by using a virtual reality headset, immediately after taking a shower. Control group: Dressing will be changed as usual without any intervention. Pain. Timepoint: 5 minutes before dressing change - during dressing change - 5 minutes after dressing change. Method of measurement: Numeric rating scale. Comfort. Timepoint: 5 minutes after changing the dressing. Method of measurement: Visual Analogue Scale. Anxiety. Timepoint: 5 minutes before changing the dressing - 5 minutes after changing the dressing. Method of measurement: Spielberger Situational Anxiety Questionnaire. Changes in physiological indicators. Timepoint: 5 minutes before dressing change - during dressing change - 5 minutes after dressing change. Method of measurement: Researcher's observations and pulse oximeter device. Kermanshah University of Medical Sciences Approved 2024-01-16 Ethics committee of Kermanshah University of Medical Sciences Karmandan sreet of station 8, Shahid Rajaei sector, district 69, first floor, right side Kermanshah Kermanshah Iran (Islamic Republic of)