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IRCT20211123053152N1 IRCT 2021-11-25 Riphah International University VR and Informal Caregivers Effects of Virtual Reality on burden, quality of life and satisfaction in informal caregivers of stroke survivors. 2020-08-01 anticipated 66 Complete https://irct.ir/trial/60163 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Total sixty six envelops (twenty two for each group) has designed and after taking consent from the individual to enter in the trial, the one envelope is being drawn to allocate a treatment group. N/A Condition 1: . Condition 2: . Intervention 1: Intervention group: Virtual reality, The procedures will be explained to the subjects, and a demonstration of games will be given by the therapist before starting the intervention. Before the intervention, there will be a 5-minute warm-up time, and after the session there will also a 5-minute cool-down time. The Kinect training time will be 25 to 30 minutes periods interspersed with 5-minute rest, 3 days per week for 4 consecutive weeks. Intervention 2: Intervention group: Cognitive behavioral therapy, will be 25 to 30 minutes periods per day, 3 days per week, for 4 consecutive weeks. Intervention 3: Intervention group: Virtual reality and cognitive behavioral therapy, for 25 to 30minutes per day, 3 days per week for 4 consecutive weeks. Yes - There is a plan to make this available What will be shared: The data of participants who are undergone in the virtual realty group will be shared. When: The data will be available from March 2022 till December 2022. To whom: People working in academic, research institutes and clinical sites Conditions: Advance analysis of the data, future prospects of research and clinical in this area of interest Where to obtain: marriumbatool25@gmail.com How to obtain: Request through email and provided in response Comments:
public Research Ethical Committee, Riphah International University
Westridge Campus, Potohar Tower, Near Nisar Hospital, Lane 5,Peshawar Road, Rawalpindi
Islamabad Pakistan 46000 +92 51 5166813 obaid.baig@riphah.edu.pk Riphah International University scientific Mirza Obaid Baig
Westridge Campus, Peshawar Road
Rawalpindi Pakistan 46000 +92 51 5166813 dxo3@hotmail.com Riphah International University Pakistan Taking care of a stroke patient ≥ 3 months 20 years 40 years Both Caregivers taking care of more than one patient Caregivers who are suffering from a Neurological or Orthopedic disease. Included caregiver was no longer the primary caregiver Treatment - Other Treatment - Other Treatment - Other Intervention group: Virtual reality, The procedures will be explained to the subjects, and a demonstration of games will be given by the therapist before starting the intervention. Before the intervention, there will be a 5-minute warm-up time, and after the session there will also a 5-minute cool-down time. The Kinect training time will be 25 to 30 minutes periods interspersed with 5-minute rest, 3 days per week for 4 consecutive weeks. Intervention group: Cognitive behavioral therapy, will be 25 to 30 minutes periods per day, 3 days per week, for 4 consecutive weeks. Intervention group: Virtual reality and cognitive behavioral therapy, for 25 to 30minutes per day, 3 days per week for 4 consecutive weeks. The Caregiver Strain İndex (CSI) made up of 13 items was developed by Robinson (1983) and assesses the subjective care load of the caregiver. The CSI can be used to quickly identify families with potential caregiving concerns. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Positive responses to 7 or more items on the index indicate a greater level of strain. This instrument can be used to assess individuals of any age who have assumed the role of carer for an older adult. It was developed with a sample of 132 carers providing assistance to recently hospitalized older adults. Validity of the index was found to be 0.41 and test-retest reliability 0.75. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: subjective method by CSI. The 36-Item Short Form Health Survey (SF-36) is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public. And it includes eight domains. The aim of the study is to assess the psychometric properties of the 36-Item Short Form Health Survey (SF-36) in medical students in mainland of China. SF-36 questionnaire reliability was >0.7, Where as the validity of SF-36 is >0.5. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: subjectively by SF-36. Adult Carer-Quality of Life: A simple instrument for use with adult carers that measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction. The AC-QoL's internal consistency/reliability is 0.94, indicating that the AC-QoL is a useful tool to assess the QoL of adult caregivers whereas the validity is ranging from 0.78 to 0.89. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Subjectively through AC-QOL. Riphah International University Approved 2020-08-13 Research Ethical Committee, Riphah International University Westridge Campus, Potohar Tower, Near Nisar Hospital, Lane 5,Peshawar Road, Rawalpindi Islamabad Islamabad Pakistan