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IRCT20210202050223N1 IRCT 2021-04-24 Shahroud University of Medical Sciences the effect of circadian rhythm disturbance on reward circuit and psychological functions Evaluation of the circadian rhythm disturbance impacts on the human reward system, impulsivity and cognitive performance 2021-05-13 anticipated 34 Complete https://irct.ir/trial/54084 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To equal the sample size in the two groups, the block method with a volume of 4 is used. For this purpose, 6 to four blocks will be created as follows 1- AABB 2- ABAB 3- ABBA 4- BBAA 5- BABA 6- BAAB Where A is for the intervention group and B is for the control group The random assignment will be done in such a way that a random number will be created in Excel from 0 to 9 first. Depending on which block the random number belongs to, the sequence of that block is used to assign the subjects to the control and intervention group.For example, if the random number generated is 6, the first person will be assigned to group B, the second person to group A, the third person to group A, and the fourth person to group B. To reach the calculated sample size, the random number creation will be repeated 9 times Because each time the task is assigned, four diseases are identified. It should be noted that if the random number generated is 7, 8, 9 and 0, it will be ignored. Envelopes in which the specified group is placed are used to conceal the allocation. Envelopes are numbered. After filling in the basic information of the people, an envelope is opened according to the word order of the people and the person is assigned to the desired group. To do this, 34 envelopes will be ready and individuals will be assigned to two groups. The methodology consultant determines the allocation sequence. The registration of participants and their entry according to the entry and exit criteria and obtaining informed consent is the responsibility of a trained psychologist. Then, if they are eligible, it assigns them to groups based on closed envelopes, Blinding description: n this study, participants and analysts will not be aware of the results of the study. Also, in all outcome assessments conducted by questionnaires or interviews by a psychologist colleague, the research colleagues are unaware of how the participants are placed in the groups. N/A circadian rhythm disorder (shift work type). Intervention 1: Intervention group: The intervention for participants lasts for 9 days, the first 3 days are related to getting used to the conditions of the study environment.from the fourth day, the circadian rhythm disturbance protocol will be applied In the first three days of the study, participants eat breakfast at seven in the morning, lunch at noon and dinner at seven in the evening. From the fourth day, the intervention is as follows: breakfast at seven in the morning, lunch at seven in the afternoon and dinner at twelve at night.Sleep patterns in this group are also planned in such a way that the participants of the intervention group are awake during the night with 450 lux light in the room and are allowed to sleep at eleven o'clock in the morning every day until seven o'clock in the evening with 90 lux light. And research assistants oversee the accurate implementation of this model. Intervention 2: Control group: Participants in the control group are also present on the experimental site for 9 days,The meal times in the control group in all 9 days of presence in the experimental site are as follows: they eat breakfast at seven in the morning, lunch at noon and dinner at seven in the evening, and the patterns of sleeping and waking up are as follows: During the night, between eleven o'clock at night and seven o'clock in the morning, with 0 lux light, they can have a complete and normal night's sleep. Yes - There is a plan to make this available What will be shared: All personal data of the participants will share without name and personal information (unidentified) When: the access period start 6 months after results publication To whom: researcher who are working in academic and scientific institutions Conditions: the use of all data or documents for researcher for using in their research with reference to the source is allowed Where to obtain: To researcher of this study,Mohammad Niroumand Sarvandani refer to email address: m.niroumand@shmu.ac.ir How to obtain: by sending an email to m.niroumand@shmu.ac.ir. all the demanded files will be provided to the applicant within 10 working days Comments:
public Mohammad Niroumand Sarvandani
No.108,Saman dormitory,Semnan,Shahroud,Iran
Shahroud Iran (Islamic Republic of) 3614773955 +98 34 3245 4926 m.niroumand@shmu.ac.ir Shahroud University of Medical Sciences scientific Mohammad Niroumand Sarvandani
No.108,Saman dormitory,Semnan,Shahroud,Iran
Shahroud Iran (Islamic Republic of) 3614773955 +98 34 3245 4926 m.niroumand@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Male gender right handed Age range between 18 and 25 years Regular rhythm of sleep and wakefulness in the past month (8 to 10) hours of sleep a night 18 years 25 years Male Having a history of psychiatric disorder Having a history of substance abuse Use of psychiatric drugs Having a general medical disorder that endangers participants health during the test Having a history of brain trauma Having a metal body in the body, including platinum, fragments or iron particles Having an irregular rhythm of sleeping and waking in the last month (8 to 10) hours of sleep at night (night shift work) Having body mass index higher than 30 G47.26 Circadian rhythm sleep disorder, shift work type Lifestyle Lifestyle Intervention group: The intervention for participants lasts for 9 days, the first 3 days are related to getting used to the conditions of the study environment.from the fourth day, the circadian rhythm disturbance protocol will be applied In the first three days of the study, participants eat breakfast at seven in the morning, lunch at noon and dinner at seven in the evening. From the fourth day, the intervention is as follows: breakfast at seven in the morning, lunch at seven in the afternoon and dinner at twelve at night.Sleep patterns in this group are also planned in such a way that the participants of the intervention group are awake during the night with 450 lux light in the room and are allowed to sleep at eleven o'clock in the morning every day until seven o'clock in the evening with 90 lux light. And research assistants oversee the accurate implementation of this model. Control group: Participants in the control group are also present on the experimental site for 9 days,The meal times in the control group in all 9 days of presence in the experimental site are as follows: they eat breakfast at seven in the morning, lunch at noon and dinner at seven in the evening, and the patterns of sleeping and waking up are as follows: During the night, between eleven o'clock at night and seven o'clock in the morning, with 0 lux light, they can have a complete and normal night's sleep. Impulsivity score in Bart's Impulsivity Questionnaire. Timepoint: Beginning of the intervention (before the start of the intervention) and end of the intervention (immediately after the end of the intervention). Method of measurement: Bart's Impulsivity Questionnaire. Assessment of Cognitive functions. Timepoint: Beginning of the intervention (before the start of the intervention) and end of the intervention (immediately after the end of the intervention). Method of measurement: Brief Cognitive Rating Scale. Assessment of presence or absence of mood rhythmicity. Timepoint: Four hours before the intervention and four hours after the intervention. Method of measurement: Mood Rhythm Instrument (MRhI). Evaluation of the performance of the reward system (mesocortico limbic circuit). Timepoint: Three hours before the intervention and three hours after the intervention. Method of measurement: Functional magnetic resonance imaging. Performance in high-risk decision test (due to reaction time). Timepoint: Three hours before the intervention and three hours after the intervention. Method of measurement: Functional magnetic resonance imaging (GO/NO GO task). Vulnerability score for substance use and addictive behaviors test. Timepoint: Two hours before the intervention and two hours after the intervention. Method of measurement: Vulnerability to substance use and addictive behaviors test. Impulsivity score in Bart's Impulsivity Questionnaire. Timepoint: Beginning of the intervention (before the start of the intervention) and end of the intervention (immediately after the end of the intervention). Method of measurement: Bart's Impulsivity Questionnaire. Assessment of Cognitive functions. Timepoint: Beginning of the intervention (before the start of the intervention) and end of the intervention (immediately after the end of the intervention). Method of measurement: Brief Cognitive Rating Scale. Assessment of presence or absence of mood rhythmicity. Timepoint: Four hours before the intervention and four hours after the intervention. Method of measurement: Mood Rhythm Instrument (MRhI). Evaluation of the performance of the reward system (mesocorticolimbic circuit). Timepoint: Three hours before the intervention and three hours after the intervention. Method of measurement: Functional magnetic resonance imaging. Performance in high-risk decision test (due to reaction time). Timepoint: Three hours before the intervention and three hours after the intervention. Method of measurement: Functional magnetic resonance imaging (GO/NO GO task). Vulnerability score for substance use and addictive behaviors test. Timepoint: Two hours before the intervention and two hours after the intervention. Method of measurement: Vulnerability to substance use and addictive behaviors test. Shahroud University of Medical Sciences Approved 2021-02-07 Ethics committee of Shahroud university of medical science Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran shahroud Semnan Iran (Islamic Republic of)