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IRCT20190315043062N4 IRCT 2025-07-04 Rasht University of Medical Sciences Impact of Virtual Reality on Happiness and Quality of Life Among Elderly Hemodialysis Patients Investigating the Impact of Virtual Reality on Happiness and Quality of Life Among Elderly Hemodialysis Patients : A Randomized Controlled Trial 2025-09-01 anticipated 54 Complete https://irct.ir/trial/84489 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: In this study, In this study, participants will be randomly assigned to one of the following two intervention sequences: Group A: Intervention 1 → Washout Period → Intervention 2 Group B: Intervention 2 → Washout Period → Intervention 1 To ensure equal allocation of participants to each sequence, a block randomization method with a fixed block size of 6 will be used. In total, 9 blocks of 6 will be considered to allocate 54 participants (27 per sequence) equally. The allocation sequence will be generated via the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists Participants will be allocated to one of the two sequences based on the order of entry into the study, according to the generated randomization list. To reduce bias, the randomization sequence will be generated and implemented by an individual independent of the research team who has no role in the data collection, assessment, or analysis process. N/A End stage renal disease. Intervention 1: Intervention group: The first group will be exposed to watching 360-degree virtual reality 3D movies in the entertainment and entertainment axis (travel, tourism and pilgrimage) using a virtual reality headset. This intervention will be done for 10-15 minutes and 3 times a week. After observing a 2-week time interval to clear the effect of the intervention, during the next 4-week period, the content of the virtual reality movies will be switched between the two intervention groups. After the end of the intervention, the follow-up period will be conducted within 2 weeks. Intervention 2: Intervention group: The second group will be exposed to watching 360-degree virtual reality 3D movies in the relaxing and exciting axis using a virtual reality headset. This intervention will be done for 10-15 minutes and 3 times a week.After observing a 2-week time interval to clear the effect of the intervention, during the next 4-week period, the content of the virtual reality movies will be switched between the two intervention groups. After the end of the intervention, the follow-up period will be conducted within 2 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Azar Darvishpour
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
Langeroud Iran (Islamic Republic of) 44771-66595 +98 13 4253 6263 darvishpour@gums.ac.ir Rasht University of Medical Sciences scientific Azar Darvishpour
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
Langeroud Iran (Islamic Republic of) 44771-66595 +98 13 4253 6263 darvishpour@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Age 65 years and older diagnosis of end-stage renal disease (ESRD) having a minimum duration of hemodialysis of 3 months having at least 3 hemodialysis sessions per week, willingness and informed consent to participate in the research project having the ability to speak and communicate obtaining a score of 7 or higher on the AMT tool to assess normal cognitive status 65 years no limit Both Severe cognitive impairment Visual or hearing impairments that prevent the use of VR Previous experience with VR technology Severe vision and hearing problems Musculoskeletal problems in the head and neck area, a history of severe and frequent headaches and migraines Malignant diseases such as cancer and neurological and psychiatric diseases and epilepsy such that the patient is under treatment History of taking antidepressants Physical diseases other than diabetes and hypertension N18.6 End stage renal disease Other Other Intervention group: The first group will be exposed to watching 360-degree virtual reality 3D movies in the entertainment and entertainment axis (travel, tourism and pilgrimage) using a virtual reality headset. This intervention will be done for 10-15 minutes and 3 times a week. After observing a 2-week time interval to clear the effect of the intervention, during the next 4-week period, the content of the virtual reality movies will be switched between the two intervention groups. After the end of the intervention, the follow-up period will be conducted within 2 weeks. Intervention group: The second group will be exposed to watching 360-degree virtual reality 3D movies in the relaxing and exciting axis using a virtual reality headset. This intervention will be done for 10-15 minutes and 3 times a week.After observing a 2-week time interval to clear the effect of the intervention, during the next 4-week period, the content of the virtual reality movies will be switched between the two intervention groups. After the end of the intervention, the follow-up period will be conducted within 2 weeks. Happiness. Timepoint: Data will be collected in three stages: pre-test, post-test, and follow-up. Method of measurement: Oxford Happiness Questionnaire. Quality of Life. Timepoint: Data will be collected in three stages: pre-test, post-test, and follow-up. Method of measurement: Kidney Patients Quality of Life Questionnaire (KDQOL-SF). Rasht University of Medical Sciences Approved 2025-06-25 Ethics Committee of Guilan University of Medical Sciences Vice Chancellor for Research and Technology., in front of the 17 Shahrivar Hospital., Shahid Siadati Street., Namjo Street Rasht Guilan Iran (Islamic Republic of)