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IRCT20190627044035N1 IRCT 2020-04-02 Iran University of Medical Sciences Desensitization of motion sickness in military pilot students: clinical and fMRI outcomes Desensitization of motion sickness in military pilot students: clinical and fMRI outcomes 2019-09-23 anticipated 12 Complete https://irct.ir/trial/45795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher allocate one number to each subject, using a computerized randomization software. Odd number put subject in intervention group one and even number locate him in intervention group two. Both participants and assessors are blinded to this grouping, Blinding description: The participants in each group, after being assigned, became aware of their group's intervention, so they were unaware of the other group's intervention so remained blind to type of the groups. Flight surgeon and flight teacher ( final assessor of efficiency of intervention in flight field) were not aware of the groups allocation. N/A motion sickness. Intervention 1: Intervention group one: only incremental coriolis stimulation therapy ( 20 sessions of cross-coupled coriolis stimulation is performed as follows: the subjects sit on Barany chair while turning in two directions around vertical axis, simultaneously with head motions in up and down, and right and left directions. Time, velocity, and acceleration of rotation are gradually increased until the subjects can tolerate 20 minutes rotation with velocity of 120 degree per seconds, without nausea. Intervention 2: Intervention group two: In addition to Intervention in group one, this group attend at 10 sessions of breathing and relaxation exercises using neurofeedback software, 3 to 5 sessions of consultation by aerospace-trained psychologist, and teaching of balance exercises to daily perform for two weeks. Yes - There is a plan to make this available What will be shared: All raw data will be shared after removing subject names, including brain images and their processed information, videonystagmography, video head impulse test, posturography, questionnaires, and coriolis test on Barany chair, and also study protocol, statistical tables and figures, and informed consent form. When: Available from June 2020 To whom: All addressed and related researchers or organizations Conditions: - Application from the referenced university, laboratory, or organization - Commitment to correctly reference this study Where to obtain: Researcher: Mehrnaz Hosseini E.mail: mehrnaz.hosseini@yahoo.com No. 11, Mouzeh alley, North Sohrevardi street, Seyyed khandan, Tehran, Iran. How to obtain: Application must send to researcher's E.mail and include formal requisition from the related organization. Then the data will be sent to the applicant After confirmation by supervisor at Iran University of Medical Sciences, Comments:
public Mehrnaz Hosseini
No. 11, Mouzeh Alley, North Sohrevardi street, Seyyed Khandan
Tehran Iran (Islamic Republic of) 1555817114 +98 21 8851 6204 Mehrnaz.Hosseini@yahoo.com Iran University of Medical Sciences scientific Mehrnaz Hosseini
No. 11, Mouzeh Alley, North Sohrevardi street, Seyyed Khandan
Tehran Iran (Islamic Republic of) 1555817114 +98 21 8851 6204 Mehrnaz.Hosseini@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) All pilot trainees with remained motion sickness symptoms ( diagnosed by flight surgeon) on three consecutive flights 21 years 24 years Male Existence of any pathology of gastrointestinal, neurotologic, psychiatry or psychology Possess any prohibition criteria for MRI, such as clastrophobia or any metal implant in body No willingness to participate in study T75.3 Motion sickness Rehabilitation Rehabilitation Intervention group one: only incremental coriolis stimulation therapy ( 20 sessions of cross-coupled coriolis stimulation is performed as follows: the subjects sit on Barany chair while turning in two directions around vertical axis, simultaneously with head motions in up and down, and right and left directions. Time, velocity, and acceleration of rotation are gradually increased until the subjects can tolerate 20 minutes rotation with velocity of 120 degree per seconds, without nausea. Intervention group two: In addition to Intervention in group one, this group attend at 10 sessions of breathing and relaxation exercises using neurofeedback software, 3 to 5 sessions of consultation by aerospace-trained psychologist, and teaching of balance exercises to daily perform for two weeks. Degree of activation of brain regions. Timepoint: one day before and after intervention period. Method of measurement: functional magnetic resonance imaging (fMRI). Eye movement response parameters. Timepoint: up to one week before and after intervention period. Method of measurement: videonystagmography (VNG) and video head impulse test (vHIT). Sensory adequacy and organization for postural control. Timepoint: up to one week before and after intervention period. Method of measurement: posturography. Improvement in subjective sense of symptoms. Timepoint: up to one week before and after intervention period. Method of measurement: filling motion sickness assessment questionnaire (MSAQ) and misery scale (MISC) after coriolis stimulation on barany chair. Functional improvement in real flight. Timepoint: up to two weeks after intervention. Method of measurement: report by flight surgeon. Iran University of Medical Sciences Approved 2019-07-20 Ethics committee of Iran University of Medical Sciences Hemmat highway Tehran Tehran Iran (Islamic Republic of)