Clinical Trial Protocol Iranian Registry of Clinical Trials
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Clinical Trial Protocol Iranian Registry of Clinical Trials 23 Sep 2021 The effect of Benson relaxation method on the rate of fatigue due to caregivers burden of patients treated with hemodialysis. Protocol summary Main outcome variables Caregiver burden in physical, psychological, social and Study aim developmental dimensions and time dimension The effect of Benson relaxation method on the rate of care caregiver burden on caregiver of undergoing General information hemodialysis Design Reason for update A two-stage clinical trial with a control group, one-way Acronym blind and randomized groups using a random number IRCT registration information table.The sample size is 70 people. IRCT registration number: IRCT20201228049859N1 Settings and conduct Registration date: 2021-02-01, 1399/11/13 The trial will be held in selected teaching hospitals of Registration timing: prospective Isfahan University of Medical Sciences.Samples will be taken randomizing from the caregivers of hemodialysis patients and divided into two groups of control and Last update: 2021-02-01, 1399/11/13 intervention and the information obtained from the Update count: 0 questionnaire will be compared in before and after the Registration date intervention. The research units in the intervention group 2021-02-01, 1399/11/13 will be unaware of the existence of the control group. Participants/Inclusion and exclusion criteria Registrant information Entry requirements: sample should be the main Name caregiver of the patient with a history of at least 3 massoumeh maki months of hemodialysis and live with him / her and not Name of organization / entity take care his / her profession. The degree of dependence Islamic Azad Univercity of the patient on the caregiver is semi-dependent to Country complete dependence and the caregiver experiences Iran (Islamic Republic of) moderate to high care pressure and is 25 to 50 years old. Phone Be literate, have the ability to perform relaxation +98 31 5261 1811 techniques and take . should not have a history of Email address No entry [email protected]؛ chronic illness and mental illness requirements:Use of other pharmacological and non- Recruitment status pharmacological methods of relaxation Recruitment complete Intervention groups Funding source First, the questionnaire is completed by the samples of both groups then Benson relaxation method training will be given by the samples of the intervention group .The Expected recruitment start date samples are perform the Benson relaxation method for 2021-02-08, 1399/11/20 one month, twice a day for 15 minutes each time .At the Expected recruitment end date end of the intervention, the fatigue responsibility 2021-03-10, 1399/12/20 questionnaire will be completed again by the samples of Actual recruitment start date both groups. empty 1 Actual recruitment end date Secondary Ids empty Trial completion date empty empty Ethics committees Scientific title The effect of Benson relaxation method on the rate of fatigue due to caregivers burden of patients treated with 1 hemodialysis. Ethics committee Name of ethics committee Public title Ethics committment of Isfahan University of Medical The effect of Benson relaxation method on the rate of Science fatigue due to caregivers burden of hemodialysis Street address patients Daneshgah Blvd.,hakim nezami Ave Purpose City Supportive Isfahan Inclusion/Exclusion criteria Province Inclusion criteria: Isfehan Be the primary caregiver and family member. The Postal code degree of patient dependence on the caregiver is semi- 8189739433 dependent to complete dependent Experience moderate Approval date to high care pressure. Be careful of reading and writing 2020-08-15, 1399/05/25 literacy. Caregivers age 25 to 50 years. Have no history Ethics committee reference number of chronic physical or mental illness. Do not be under IR.MUI.MED.REC.1399.733 stress management training during the study. Exclusion criteria: Change the type of patient treatment before Health conditions studied randomization Use of other methods to reduce stress and smoking and sedatives during the intervention 1 Age From 25 years old to 50 years old Description of health condition studied Gender Burden of treatment Both ICD-10 code Y07.521 Phase ICD-10 code description N/A Mental health provider, perpetrator of maltreatment and Groups that have been masked neglect Participant Primary outcomes Sample size Target sample size: 70 Randomization (investigator's opinion) 1 Randomized Description Randomization description Burden of treatment The research sample is a simple individual randomization Timepoint method using a table of random numbers from the Baseline and one month after intervention caregivers of hemodialysis patients who are eligible for Method of measurement inclusion in the study and Assignment of samples to the Burden of treatment inventory intervention and random control group using a selection of sealed envelopes. Secondary outcomes Blinding (investigator's opinion) Single blinded empty Blinding description Study participants are unaware of the assignment of the Intervention groups control group and assume that all samples receive intervention.To perform blinding, the intervention will be performed in a place or time when there is no encounter 1 between the control and intervention groups. Description Placebo Intervention group: Benson's relaxation method is taught Not used in three thirty-minute sessions in the form of lectures Assignment and practical presentations, educational pamphlets and Parallel follow-up of the correct implementation of the Other design features intervention for one month, twice a day, in the morning 2 and in the evening. 3 Category Recruitment center Lifestyle Name of recruitment center Amin Hospital 2 Full name of responsible person Hamid Melali Description Street address Control group: Without intervention Ibn Sina Street Category City N/A Isfahan Province Recruitment centers Isfehan Postal code ۸۱۴۸۶۵۳۱۴۱ 1 Phone Recruitment center +98 31 3445 5051 Name of recruitment center Fax Al-Zahra Hospital +98 31 3445 9002 Full name of responsible person Email Parviz Kashefi [email protected] Street address Web page address University Blvd.,Sefeh St http://amin.mui.ac.ir City Isfahan Sponsors / Funding sources Province Isfehan 1 Postal code 8174675731 Sponsor Phone Name of organization / entity +98 31 3620 2020 Esfahan University of Medical Sciences Fax Full name of responsible person +98 31 3669 1510 Shaghayegh haghjoy javanmard Email Street address [email protected] Vice Chancellor for Research and Technology, Web page address Building No. 4 - Isfahan University of Medical Sciences http://alzahra.mui.ac.ir and Health Services, Hezar Jerib St City Isfahan 2 Province Recruitment center Isfehan Name of recruitment center Postal code 8346181746 Noor and Ali Asghar Hospitals Phone Full name of responsible person +98 31 3668 8138 Ramin Sami Fax Street address +98 31 3668 5149 Intersection of Hasht Behesht Street and Governor Email Street [email protected] City Web page address Isfahan http://research.mui.ac.ir/ Province Grant name Isfehan Grant code / Reference number Postal code Is the source of funding the same sponsor 8145831451 organization/entity? Phone Yes +98 31 3222 2127 Title of funding source Fax Esfahan University of Medical Sciences +98 31 3222 2135 Proportion provided by this source Email 100 [email protected] Public or private sector Web page address Public http://nour.mui.ac.ir Domestic or foreign origin 3 Domestic Person responsible for updating data Category of foreign source of funding empty Contact Country of origin Name of organization / entity Type of organization providing the funding Islamic Azad University Academic Full name of responsible person Massoumeh maki Person responsible for general inquiries Position Consultant Contact Latest degree Name of organization / entity Master Islamic Azad University Other areas of specialty/work Full name of responsible person Nursery Massoumeh maki Street address Position Nursing & midwifery department , Islamic Azad Consultant University falavarjan branch, university Blvd , Latest degree City Master Isfahan Other areas of specialty/work Province Nursery Isfehan Street address Postal code Nursing & midwifery department , Islamic Azad 8189739433 University falavarjan branch, university Blvd , Phone City +98 31 3743 5263 Isfahan Email Province [email protected] Isfehan Postal code Sharing plan 8189739433 Phone Deidentified Individual Participant Data Set (IPD) +98 31 3743 5263 Yes - There is a plan to make this available Email Study Protocol [email protected] Yes - There is a plan to make this available Statistical Analysis Plan Person responsible for scientific Yes - There is a plan to make this available inquiries Informed Consent Form Yes - There is a plan to make this available Contact Clinical Study Report Name of organization / entity Yes - There is a plan to make this available Esfahan University of Medical Sciences Analytic Code Full name of responsible person Yes - There is a plan to make this available Nahid shahgholian Data Dictionary Position Yes - There is a plan to make this available Consultant Title and more details about the data/document Latest degree Sharing personal data is possible after identifying Master individuals and data related to the main outcome. Other areas of specialty/work When the data will become available and for how Nursery long Street address Access period starts 6 months after the results are Sefeh Ave published City To whom data/document is available Isfahan Documents received permission to study for researchers Province working in academic and scientific institutions and Isfehan individuals working in the industry will be there. Postal code Under which criteria data/document could be used 8189739433 It is possible to analyze the data in accordance with the Phone research method +98 31 3333 0245 From where data/document is obtainable Fax Email address +98 31 3669 9398 What processes are involved for a request to access Email data/document [email protected] The process of receiving data and documents includes: 4 receiving the application via e-mail address, providing the desired documents and sending it to the applicant. Comments 5.