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IRCT20220813055673N1 IRCT 2022-12-11 Kerman University of Medical Sciences The effect of mindfulness on resilience ,quality of life and individual independence in patients with spinal cord injury MBSR یا Mindfulness based stress reduction Comparison of the effectiveness of mindfulness with routine care on resilience ,quality of life and individual independence in patients with spinal cord injury 2023-01-05 anticipated 62 Complete https://irct.ir/trial/65323 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: According to the availability of the list of patients referred to two support centers, the list will be given to the statistician. The statistician who is blinded to the allocation codes to the groups, divides the 62 people with the dropout rate, into either the control or intervention group which is provided by Excel software, Blinding description: The list is provided to the statistician, and he assigns people to each of the control and intervention groups according to the number of participants, which is 62 people including the dropout, using Excel software and without knowing the allocation of codes to the groups. In this study, statisticians, Data Safety and Monitoring Committee and patients will be blinded to the groups. N/A spinal cord injury. Intervention 1: Intervention group: In this research, the intervention is Mindfulness based stress reduction in the form of 8 weekly face-to-face sessions of 90 minutes in the format of groups of 5-16 people for patients who have the possibility to attend treatment centers and to conduct the same sessions individually with the presence of the researcher at the patients' homes. In between the sessions, the researcher accompanies the patients online and provides them with the educational content of each session in the form of an audio file on the day of the training and reminds them of the daily repetition of the previous sessions. Intervention 2: Control group: 31 people who answer the questionnaires at all three specified times are included in the control group, which will not receive any special training except routine care at home during the intervention period. If there will be positive effect of the training on outcome measures, the intervention will be conducted for control group too. 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 more information in this regard.
public Omsalimeh Roudi Rashtabadi
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5201 fatroody@yahoo.com Kerman University of Medical Sciences scientific Omsalimeh Roudi Rashtabadi
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 fatroody@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) At least 12 weeks have passed since the onset of the disease and up to a maximum of 5 years They must have the ability to use a mobile phone, so these people are selected from the 18-year-old age group without any age limit The ability to communicate in Farsi Having a mobile phone with an Android system and media applications The patient has not participated in similar research such as cognitive therapy or psychotherapy in the last 3 months 18 years no limit Both Withdrawal of cooperation Using psychotropic drugs, neuropsychiatric drugs and under the treatment of a psychiatrist Previous experience of a similar intervention on the patient Diseases associated with lesions in the studied sample, such as cognitive disorders and physical diseases such as cardiovascular disorders, diabetes, etc. S24.109S Unspecified injury at unspecified level of thoracic spinal cord, sequela Rehabilitation Rehabilitation Intervention group: In this research, the intervention is Mindfulness based stress reduction in the form of 8 weekly face-to-face sessions of 90 minutes in the format of groups of 5-16 people for patients who have the possibility to attend treatment centers and to conduct the same sessions individually with the presence of the researcher at the patients' homes. In between the sessions, the researcher accompanies the patients online and provides them with the educational content of each session in the form of an audio file on the day of the training and reminds them of the daily repetition of the previous sessions. Control group: 31 people who answer the questionnaires at all three specified times are included in the control group, which will not receive any special training except routine care at home during the intervention period. If there will be positive effect of the training on outcome measures, the intervention will be conducted for control group too. The score of Conner & Davidson resilience Questionnaire. Timepoint: At the point of recruitment day, 8weeks and 1 month later. Method of measurement: Conner & Davidson Resilience questionnaire. Spinal cord injury Quality of life. Timepoint: At the point of recruitment day, and 1 month later. Method of measurement: SCI QL23 (Spinal cord injury Quality of life questionnaire). Spinal cord Independence. Timepoint: At the point of recruitment day, 8weeks and 1 month later. Method of measurement: SCIM III(Spinal cord Independence Measure). Kerman University of Medical Sciences Approved 2022-11-13 Ethics committee of Kerman University of Medical Sciences No. 2, Ibn Sina Street, Deputy of research and technology Bldg. Kerman Kerman Iran (Islamic Republic of)