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IRCT20240605062020N1 IRCT 2024-07-25 Islamic Azad University Examining the effect of exercise in people with panic symptoms The effectiveness of cognitive-behavioral therapy combined with physical exercises on anxiety symptoms, resiliency and quality of life in individual with panic symptoms 2024-08-22 anticipated 30 Complete https://irct.ir/trial/77322 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Blocking is usually used in order to balance the number of samples assigned to each of the studied groups. This feature helps researchers to have the same number of samples assigned to each of the studied groups in cases where intermediate analyzes are needed during the sampling process. The randomization method here is block randomization with individual units and the use of SAS software as a randomization tool. Concealment of random assignment refers to the method used to perform a random sequence on the participants in the study, in a way that is done before assigning the individual to the group. The assignment is not specific. Without hiding the random sequence, there is a possibility of revealing the random sequence, which eventually weakens the randomization process. Here, to hide the allocation concealment of opaque sealed envelopes Waxed random sequence (SNOSE) was used, Blinding description: In this study, the participants, the researcher, and the person in charge of data collection have been kept blind. In such a way that none of those who were mentioned know which persons and which group is the control and which is the experiment. N/A Panic symptoms. Intervention 1: Intervention group: Intervention group: It is the group that receives the intervention. The intervention includes 10 sessions of cognitive behavioral therapy two days a week and 15 sessions of aerobic exercise three days a week. Intervention 2: Control group: It is a group that performs the pre-test and post-test together with the intervention group. The intervention of group therapy and exercise is not done for the control group. Yes - There is a plan to make this available What will be shared: The results of all things that can be published include: participant data file, study protocol, statistical analysis map, informed consent form, clinical study report, etc. can be shared. When: The access period starts 6 months after the results are published. To whom: To receive data and other study documents, researchers working in academic and scientific institutions or people working in the industry can apply. Conditions: The data and documentation of the study can be used for all research and treatment works. Where to obtain: Requesters can contact the e-mail address behrouzieh92@gmail.com to receive the desired documents or data. How to obtain: Applicants will receive the documents within a week after referring to the e-mail address behrouzieh92@gmail.com and stating the reason for using the documents, after reading and reviewing their application. Comments:
public Fatemeh Behrouzieh
Unit 14، No. 13, 12 Qajarian Alley, 10 Hashemi Street, Hashemi Rafsanjani Highway
Mashhad Iran (Islamic Republic of) 9186333080 +98 51 3525 8576 fbehrouzieh@icloud.com Islamic Azad University scientific Fatemeh Behrouzieh
Unit 14، No. 13, 12 Qajarian Alley, 10 Hashemi Street, Hashemi Rafsanjani Highway
Mashhad Iran (Islamic Republic of) 9186333080 +98 51 3525 8576 fbehrouzieh@icloud.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) All people with panic disorder who are between 12 and 25 years old. 12 years 25 years Both People who do not have symptoms of panic disorder. People whose age is less than 12 years and more than 25 years. Lifestyle Lifestyle Intervention group: Intervention group: It is the group that receives the intervention. The intervention includes 10 sessions of cognitive behavioral therapy two days a week and 15 sessions of aerobic exercise three days a week. Control group: It is a group that performs the pre-test and post-test together with the intervention group. The intervention of group therapy and exercise is not done for the control group. Anxiety score in Beck Anxiety Questionnaire. Timepoint: Anxiety levels are measured at the beginning of the study (before the start of the intervention) and at the end of the study (end of the intervention). Method of measurement: Beck anxiety questionnaire. Flexibility score in acceptance and action questionnaire. Timepoint: Measuring the degree of flexibility is done at the beginning of the study (before the start of the intervention) and at the end of the study (end of the intervention). Method of measurement: Flexibility in the acceptance and action questionnaire. نمره میزان کیفیت زندگی در زمینه‌یابی سلامت 36 آیتمی (فرم کوتاه)36-item quality of life score in health research (short form). Timepoint: Quality of life is measured at the beginning of the study (before the start of the intervention) and at the end of the study (end of the intervention). Method of measurement: 36-item health background questionnaire (short form). Islamic Azad University Approved 2024-06-05 Research Ethics Committee of Islamic Azad University - Neishabur branch Unit 14، No. 13, 12 Qajarian Alley, 10 Hashemi Street, Hashemi Rafsanjani Highway Mashhad Razavi Khorasan Iran (Islamic Republic of)