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IRCT20250727066650N1 IRCT 2025-08-03 Semnan University of Medical Sciences The effect of virtual reality glasses on vital signs of patients with stone disease. Studying the effect of mind-bending technique through virtual reality glasses on physiological indicators of patients undergoing extracorporeal lithotripsy using shockwaves. 2025-09-23 anticipated 99 Recruiting https://irct.ir/trial/85162 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Sampling will be done randomly. Patients requiring extracorporeal lithotripsy at Kowsar Hospital who are eligible for inclusion in the study will be divided into two equal groups (50 people in each group) using sealed envelopes containing the letters (I) for intervention and (C) for control, after accepting and fully explaining the plan and obtaining informed consent. The envelope selection will be done by the patient before the intervention begins. Due to random sampling, the study subjects will have an equal chance of being selected into the two groups. N/A kidney stones. Intervention 1: Intervention group: After obtaining the ethics code and IRCT code, the researcher will refer to Kowsar Hospital in Semnan and take a sample from all patients who meet the conditions for inclusion in the study. Also, initially, an informed consent form is obtained from the patients, and then a demographic information questionnaire is presented to the patients and completed. Out of a total of 100 samples in the project, 50 people will be classified in this group. After sampling and the presence of patients in the intervention group, the method will be explained in detail to the patient by the researcher. The intervention includes performing lithotripsy (about thirty minutes to an hour, depending on the doctor's opinion) and using virtual reality glasses for patients from the beginning to the end of the process. In this intervention, virtual reality glasses will be placed over the patient's eyes, and clips of nature and relaxing landscapes will be used to distract and calm the patient And patients are asked to imagine themselves in the space related to the displayed scenes. It is obvious that during the intervention, the patient hears completely in order to establish compliance with the treatment and there is no need to stop the intervention when the doctor and technician give instructions. In this intervention, patients' physiological indicators such as blood pressure, heart rate, arterial oxygen saturation, and body temperature will be measured in four stages. The first stage is the measurement of physiological indicators 15 minutes before the start of the intervention, at which point the distraction technique has not yet been used. Then, the necessary coordination will be made with the relevant doctor and technician to start the therapeutic intervention and perform the thought diversion technique through virtual reality glasses. This technique will be used throughout the entire lithotripsy process. Also, to ensure that the clients adapt to the aforementioned device, virtual reality glasses will be provided to the patients in the intervention group ten minutes before the start of the intervention. After applying this technique, in addition to the first stage described above, the clients' physiological needs will be measured and recorded in three other stages (15 minutes after the start of the intervention, the end of the intervention, and 15 minutes after the end of the intervention). The intervention will be carried out individually in the lithotripsy ward of Kowsar Hospital, and the aforementioned forms will be completed by the researcher, and the intervention will be carried out from 8:00 AM to 12:00 PM, depending on the presence of the technician and the relevant doctor. A sphygmomanometer will be used to measure physiological indicators, and a finger pulse oximetry device available in the ward will be used to measure heart rate and oxygen saturation. Intervention 2: Control group: After obtaining the code of ethics, the researcher will refer to Kowsar Hospital in Semnan and take a sample from all patients who meet the conditions for inclusion in the study. Also, an informed consent form will be obtained from the patients first, and then a demographic information questionnaire will be presented to the patients and completed. The control group will receive routine lithotripsy care, and blood pressure, heart rate, arterial oxygen saturation, and temperature will be measured and recorded in four stages, just like the intervention group, to compare the two groups. At the end of the interventions, the control group will be provided with a pamphlet containing information about their disease so that they can benefit scientifically from the present project. The intervention will be carried out individually in the lithotripsy ward of Kowsar Hospital, and the aforementioned forms will be completed by the researcher, and the intervention will be carried out from 8:00 AM to 12:00 PM, depending on the presence of the technician and the relevant doctor. A sphygmomanometer will be used to measure physiological indicators, and a finger pulse oximetry device available in the ward will be used to measure heart rate and oxygen saturation. 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 There is no further information
public SeyedMahyar Peyman
No. 7 azarbayjab street, ajhide street , ebrahim Ave, tehran
Tehran Iran (Islamic Republic of) 1318847946 +98 21 6692 7956 mahyarpeyman1275@gmail.com Semnan University of Medical Sciences scientific SeyedMahyar Peyman
No. 7 azarbayjab street, ajhide street , ebrahim Ave, tehran
Tehran Iran (Islamic Republic of) 1318847946 +98 21 6692 7956 mahyarpeyman1275@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Minimum age 18 years Diagnosis of upper or lower urinary tract stones by a doctor and performing at least one lithotripsy procedure Ability to communicate and be alert and aware of the disease Complete client satisfaction and willingness to participate in the research 18 years no limit Both Having any type of high blood pressure (systolic blood pressure above 140 and diastolic blood pressure above 80) and any type of diabetes (HbA1C above 6.5) Types of mental illnesses Having diseases that affect hemodynamic indicators, according to the doctor's opinion Death of the client His unwillingness to continue cooperation. The presence of chronic kidney stones affecting physiological indicators N20.0 Calculus of kidney Rehabilitation N/A Intervention group: After obtaining the ethics code and IRCT code, the researcher will refer to Kowsar Hospital in Semnan and take a sample from all patients who meet the conditions for inclusion in the study. Also, initially, an informed consent form is obtained from the patients, and then a demographic information questionnaire is presented to the patients and completed. Out of a total of 100 samples in the project, 50 people will be classified in this group. After sampling and the presence of patients in the intervention group, the method will be explained in detail to the patient by the researcher. The intervention includes performing lithotripsy (about thirty minutes to an hour, depending on the doctor's opinion) and using virtual reality glasses for patients from the beginning to the end of the process. In this intervention, virtual reality glasses will be placed over the patient's eyes, and clips of nature and relaxing landscapes will be used to distract and calm the patient And patients are asked to imagine themselves in the space related to the displayed scenes. It is obvious that during the intervention, the patient hears completely in order to establish compliance with the treatment and there is no need to stop the intervention when the doctor and technician give instructions. In this intervention, patients' physiological indicators such as blood pressure, heart rate, arterial oxygen saturation, and body temperature will be measured in four stages. The first stage is the measurement of physiological indicators 15 minutes before the start of the intervention, at which point the distraction technique has not yet been used. Then, the necessary coordination will be made with the relevant doctor and technician to start the therapeutic intervention and perform the thought diversion technique through virtual reality glasses. This technique will be used throughout the entire lithotripsy process. Also, to ensure that the clients adapt to the aforementioned device, virtual reality glasses will be provided to the patients in the intervention group ten minutes before the start of the intervention. After applying this technique, in addition to the first stage described above, the clients' physiological needs will be measured and recorded in three other stages (15 minutes after the start of the intervention, the end of the intervention, and 15 minutes after the end of the intervention). The intervention will be carried out individually in the lithotripsy ward of Kowsar Hospital, and the aforementioned forms will be completed by the researcher, and the intervention will be carried out from 8:00 AM to 12:00 PM, depending on the presence of the technician and the relevant doctor. A sphygmomanometer will be used to measure physiological indicators, and a finger pulse oximetry device available in the ward will be used to measure heart rate and oxygen saturation. Control group: After obtaining the code of ethics, the researcher will refer to Kowsar Hospital in Semnan and take a sample from all patients who meet the conditions for inclusion in the study. Also, an informed consent form will be obtained from the patients first, and then a demographic information questionnaire will be presented to the patients and completed. The control group will receive routine lithotripsy care, and blood pressure, heart rate, arterial oxygen saturation, and temperature will be measured and recorded in four stages, just like the intervention group, to compare the two groups. At the end of the interventions, the control group will be provided with a pamphlet containing information about their disease so that they can benefit scientifically from the present project. The intervention will be carried out individually in the lithotripsy ward of Kowsar Hospital, and the aforementioned forms will be completed by the researcher, and the intervention will be carried out from 8:00 AM to 12:00 PM, depending on the presence of the technician and the relevant doctor. A sphygmomanometer will be used to measure physiological indicators, and a finger pulse oximetry device available in the ward will be used to measure heart rate and oxygen saturation. Blood pressure. Timepoint: From fifteen minutes before the start of the intervention to fifteen minutes after the end of the intervention. Method of measurement: A dial pressure gauge will be used to measure this variable, and then it will be recorded by the researcher in a researcher-made physiological index recording table. Arterial blood oxygen saturation. Timepoint: From fifteen minutes before the start of the intervention to fifteen minutes after the end of the intervention. Method of measurement: To measure this variable, a finger pulse oximetry device will be used, and after the measurement, the physiological data will be recorded by the researcher in a researcher-made table. Pulse rate. Timepoint: From fifteen minutes before the start of the intervention to fifteen minutes after the end of the intervention. Method of measurement: To measure this variable, a finger pulse oximetry device will be used, and after the measurement, the physiological data will be recorded by the researcher in a researcher-made table. Body temperature. Timepoint: From fifteen minutes before the start of the intervention to fifteen minutes after the end of the intervention. Method of measurement: A laser thermometer will be used to measure this variable, and after the measurement, the physiological data will be recorded by the researcher in a researcher-made table. Semnan University of Medical Sciences Approved 2025-07-12 Ethics committee of Semnan University of Medical Sciences headquarters of Semnan University of Medical Sciences and Health Services-Basij Blvd semnan Semnan Iran (Islamic Republic of)