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IRCT20220614055170N1 IRCT 2023-11-11 Kerman University of Medical Sciences Effect of guided mental imagery on motor dysfunction and balance of patients with MS Investigating the effect of guided mental imagery on motor dysfunction and balance of patients with multiple sclerosis (MS) 2023-12-21 anticipated 60 Complete https://irct.ir/trial/73642 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: The intervention in this study is in the form of nature-based guided mental imagery through the playback of an audio recording by the researcher and its confirmation by the experts in this field, through the Anker Soundcore Life 2 Neo headset with the ability to produce powerful and high-quality sound for the patient. The maximum content playback time is 15 minutes. The theme of the broadcasted file is focused on depicting a view of nature in the form of natural landscapes with accompanying sounds, while the content of that landscape, smells, sounds, sensations, etc. is reported in it. The people present in both groups will perform the 6-minute walk test and the 25-foot walk test once, and their balance will be evaluated by the Berg balance scale by the researcher and under the supervision of the relevant doctor of the project. Then, the people in the intervention group will listen to the guided mental imagery audio file for 15 minutes, and then they will perform both tests again and their balance will be evaluated by the Berg scale. Patients are given a 15-minute rest between each test. People in the control group will do all three tests again after 15 minutes of rest without listening to any audio files. In order to avoid the collision of samples in the two control and intervention groups and the possibility of exchanging information, the two groups will be examined separately on different days but under the same conditions and at the same hours of the day. It should be noted that due to the possible influence of factors such as the duration of MS, the two intervention and control groups will be matched before the intervention, Randomization description: After preparing the list of patients with multiple sclerosis in the desired centers, who meet the inclusion criteria, each patient will be given a number and then the people will be divided into two intervention and control groups according to the table of random numbers by computer, Blinding description: In this study, the participants, after declaring their desire to participate in the research and obtaining informed consent, were blinded to their allocation in the intervention and control groups. Also, the statistician who will finally analyze the results would kept blind from the allocation of people in two groups. N/A Motor and balance dysfunction. Intervention 1: Intervention group: Includes 30 eligible patients, who will perform six-minute walk, 25-foot walk, and balance tests after listening to a guided mental imagery audio file. Intervention 2: Control group: Including 30 eligible patients, who will perform the six-minute walk, 25-foot walk and balance test without receiving any intervention. Yes - There is a plan to make this available What will be shared: The data results from the intervention performed in both the intervention and control groups, including the comparison of the amount of motor disorder and balance before and after, the possible impact of information and individual characteristics of people on data changes, as well as strategies for better implementation of such intervention and limiting factors during the research, has the possibility to share When: Access period starts 6 months after the results are published To whom: University faculty members, educational, therapeutic, research centers, general public Conditions: It is allowed to use the results of this research to educate nursing students, apply them in the clinical field, continuous training of nursing staff, and for managers of clinical departments and rehabilitation centers to make appropriate decisions. Where to obtain: Access through the site of TarjomanDanesh, assistence for Research and Technology of Kerman University of Medical Sciences: https://vresearch.kmu.ac.ir Or via the following email address: shojaie.atena79@gmail.com How to obtain: The research documents will be available six months after the publication of the results on the site of TarjomanDanesh or via the mentioned email Comments:
public Atena Shojaie
Razi College of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3252 0929 shojaie.atena79@gmail.com Kerman University of Medical Sciences scientific Atena Shojaie
Razi College of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 shojaie.atena79@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Suffering from Multiple Sclerosis such as Relapsing-Remitting MS (RRMS), Primary progressive MS and Secondary progressive MS with the confirmation and diagnosis of the relevant doctor Ability to communicate in Persian Acceptable speaking ability Acceptable listening ability to clearly hear the researcher's voice and the audio file Age range between 18 and 60 years The ability to walk at least 50 meters using the patient's usual mobility aids such as canes, walkers, etc. in a six-minute walking test before the intervention Not suffering from any primary neurological, psychological, cardiac, respiratory and other diseases such as osteoarthritis or rheumatoid arthritis, etc., which affect the patient's usual movement ability. Failure to participate in a rehabilitation program or physical activity that improves and helps the disease for at least the last two months, or changing treatment in a way that affects the patient's mobility (physiotherapy or drug therapy) No use of high doses of steroids in the past month, which is defined as high-dose steroid therapy according to the following protocol: steroid use of 50 mg/day intravenously (IV) for six days, 40 mg intramuscularly (IM) for For more than 15 days, 20 mg intramuscularly for more than 30 days Not experiencing any severe clinical relapse in the disease in the past month Getting a score between 1 and 6.5 on the Extended Disability Status Scale (EDSS) means mild to moderate disability. At least one year has passed since the diagnosis of MS 18 years 60 years Both pregnancy Treatment - Other Treatment - Other Intervention group: Includes 30 eligible patients, who will perform six-minute walk, 25-foot walk, and balance tests after listening to a guided mental imagery audio file Control group: Including 30 eligible patients, who will perform the six-minute walk, 25-foot walk and balance test without receiving any intervention. The degree of motor dysfunction of the patient. Timepoint: Measuring the severity of motor dysfunction before and after the intervention. Method of measurement: 6-minute walk test and 25-foot walk test. The degree of the patient's balance disorder. Timepoint: Measuring the severity of balance disorders before and after the intervention. Method of measurement: Berg Balance scale. The degree of motor dysfunction and balance of the patient. Timepoint: Measuring the severity of motor and balance dysfunction before and after the intervention. Method of measurement: Six-minute walk test, 25-foot walk test, Berg balance scale. Kerman University of Medical Sciences Approved 2023-10-29 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, The beginning of HaftBaghAlavi Highway, ImamKhomeini Highway Kerman Kerman Iran (Islamic Republic of)