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IRCT20120215009014N497 IRCT 2024-02-14 Hamedan University of Medical Sciences Effect of white noise versus control group on the pain and anxiety of patients undergoing extracorporeal shock wave lithotripsy Effect of white noise versus control group on the pain and anxiety of patients undergoing extracorporeal shock wave lithotripsy: a randomized clinical trial 2024-03-05 anticipated 60 Complete https://irct.ir/trial/75465 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group. 3 Condition 1: Anxiety. Condition 2: Pain. Intervention 1: Intervention group: Routine care during extracorporeal shock wave lithotripsy in addition to playing white noise (including the sound of nature such as the sound of birds and the sound of water) with a frequency lower than 85 dB for 45 minutes through headphones. Intervention 2: Control group: Just routine care during extracorporeal shock wave lithotripsy. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Zahra Karimi Vafa
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 zahrakarimivafa@gmail.com Hamedan University of Medical Sciences scientific Dr. Arezoo Karampoorian
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 karampor1@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 20 to 50 years Indications for extracorporeal shock wave lithotripsy Being literate 20 years 50 years Both Having colicky kidney pains before lithotripsy Auditory disorder History of anxiety or mental disorder F06.4 G89.1 Anxiety disorder due to known physiological condition Acute pain, not elsewhere classified Treatment - Devices N/A Intervention group: Routine care during extracorporeal shock wave lithotripsy in addition to playing white noise (including the sound of nature such as the sound of birds and the sound of water) with a frequency lower than 85 dB for 45 minutes through headphones Control group: Just routine care during extracorporeal shock wave lithotripsy Pain score. Timepoint: Before the intervention and immediately after that. Method of measurement: using the Visual Analog Scale (VAS). Anxiety score. Timepoint: Before the intervention and immediately after that. Method of measurement: Using the Spielberger Anxiety Questionnaire. Hamedan University of Medical Sciences Approved 2024-02-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)