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IRCT20220520054936N1 IRCT 2022-09-07 University of social welfare and rehabilitation sciences Effect of Motivational Interview on Self-Efficacy in CVA Effectiveness of Motivational Interview on Self-Efficacy for CVA Survivors: A Randomized Controlled Trial 2022-09-23 anticipated 34 Complete https://irct.ir/trial/65157 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assigning participants to two intervention groups is done by simple randomization and lottery. After selecting all the eligible patients, two envelopes containing cards A (representative of the intervention group) or B (representative of the control group) are given to each patient by a therapist, who is not aware of the contents of the envelopes, to choose one envelope, Blinding description: After selecting all eligible patients, the initial evaluation and re-evaluation are done by a therapist who is not one of the study researchers and is unfamiliar with the grouping of patients. Assigning participants to two intervention groups is done by a therapist unaware of the contents of the envelopes. The usual occupational therapy interventions for both groups are performed by an occupational therapist unaware of the group allocation. Motivational Interview sessions for intervention group A will be held by the study researcher, who will be informed about the grouping of patients using envelopes after randomizing the patients. Data analysis is also done by an analyst unfamiliar with the grouping of patients. N/A Cerebral Vascular Accident (Stroke). Intervention 1: Intervention group (A): In addition to routine Occupational Therapy interventions, including programs to increase the level of independence in daily life activities, facilitate muscle tone, inhibit reflexes, and increase flexibility based on Brunnstrom and Bobath techniques, the recipient of 4 sessions of 30-60 minute individual Motivational Interview over four weeks by a trained therapist emphasizing the use of open-ended questions, giving feedback, counseling, validation, emphasis on control, reflection, reframing, and support conducted by the researcher in the interview room. The first session emphasizes familiarity with stroke, the causes of its occurrence, and progress, and the second session describes a day of daily life and emphasizes the examination of short-term and long-term problems, failure to observe adaptive behaviors, compensatory strategies, and increasing the quality of life. Third, with an emphasis on identifying the desired goals of the individual and the ways to achieve them to create internal motivation and also create changes to achieve favorable conditions, and the fourth session to review the talks made in the previous sessions, reminding the identified goals and Rewards are offered for achievements. It should be noted that three months before the start of the sessions, the researcher has received the necessary training under the supervision of a clinical psychologist and an Occupational Therapy specialist in the field of psychiatry who is in the research team and has obtained sufficient qualifications. Intervention 2: Control group (B): Receiving routine Occupational Therapy interventions, including programs to increase the level of independence in daily life activities, facilitate muscle tone, control reflexes and more flexibility based on Brunnstrom and Bobath techniques. Yes - There is a plan to make this available What will be shared: All data will be shared after de-identifying people in the form of participant data file, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in analysis and data dictionary. When: The access period starts 1 year after the results are published To whom: The data obtained from the current research can be sent to treatment centers and occupational therapy Departments if needed. Conditions: Apart from the analysis done by the research team on the data, no one is allowed to do any further analysis on the data. Where to obtain: Nazila AkbarFahimi: n-fahimi@uswr.ac.ir How to obtain: On average, to perform tasks related to sending files and considering the volume of files, a period of at least 2 weeks should be considered for sending data files. Comments:
public Sina Gholipour
Evin, Daneshjoo Blvd, Koodakyar Street
Tehran Iran (Islamic Republic of) 1985713871 +98 44 3346 8391 sinaghlpr@gmail.com University of social welfare and rehabilitation sciences scientific Nazila Akbar Fahimi
Evin, Daneshjoo Blvd, Koodakyar Street
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 n-fahimi@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Having informed consent to participate in the research People with history or diagnosis of Ischemic stroke by doctor's approval Scoring 5-18 in the Beck's Depression Inventory (Short Form) no limit no limit Both Inability to follow verbal commands Scoring less than 18 in the Mini-Mental State Examination I63.9 Cerebral infarction, unspecified Rehabilitation N/A Intervention group (A): In addition to routine Occupational Therapy interventions, including programs to increase the level of independence in daily life activities, facilitate muscle tone, inhibit reflexes, and increase flexibility based on Brunnstrom and Bobath techniques, the recipient of 4 sessions of 30-60 minute individual Motivational Interview over four weeks by a trained therapist emphasizing the use of open-ended questions, giving feedback, counseling, validation, emphasis on control, reflection, reframing, and support conducted by the researcher in the interview room. The first session emphasizes familiarity with stroke, the causes of its occurrence, and progress, and the second session describes a day of daily life and emphasizes the examination of short-term and long-term problems, failure to observe adaptive behaviors, compensatory strategies, and increasing the quality of life. Third, with an emphasis on identifying the desired goals of the individual and the ways to achieve them to create internal motivation and also create changes to achieve favorable conditions, and the fourth session to review the talks made in the previous sessions, reminding the identified goals and Rewards are offered for achievements. It should be noted that three months before the start of the sessions, the researcher has received the necessary training under the supervision of a clinical psychologist and an Occupational Therapy specialist in the field of psychiatry who is in the research team and has obtained sufficient qualifications. Control group (B): Receiving routine Occupational Therapy interventions, including programs to increase the level of independence in daily life activities, facilitate muscle tone, control reflexes and more flexibility based on Brunnstrom and Bobath techniques. Self-efficacy score in the General Self-efficacy Scale. Timepoint: Measuring Self-efficacy at the beginning of the study and 60 days after the start of motivational interview. Method of measurement: General Self-efficacy Scale. Quality of life score in the Quality of Life Scale. Timepoint: Measuring quality of life at the beginning of the study and 60 days after the start of the motivational interview. Method of measurement: Quality of Life Scale. Functional Independence Score in the Functional Independence Scale. Timepoint: Measuring functional independence at the beginning of the study and 60 days after the start of motivational interview. Method of measurement: Functional Independence Scale. Brunnestrom Recovery Level. Timepoint: Determining Brunnestrom recovery level at the beginning of the study and 60 days after the start of the motivational interview. Method of measurement: Brunnestrom Approach. University of social welfare and rehabilitation sciences Approved 2022-05-20 Ethics committee of University of social welfare and rehabilitation Evin, Daneshjoo Blvd, Koodakyar Street Tehran Tehran Iran (Islamic Republic of)