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IRCT20220603055068N1 IRCT 2022-07-12 Shiraz University of Medical Sciences The effect of counseling and telephone follow-up on anxiety and the burden of care The effect of nurse counseling and telephone follow-up on anxiety and care burden of family caregivers of patients with spinal cord injury 2022-08-06 anticipated 60 Complete https://irct.ir/trial/63964 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The random allocation method in this study will be permutation block method. This method is implemented by considering blocks of 2 so that the total number of possible binary permutations is equal to 2. The desired random list of 60 which includes 30 blocks of 2 is produced and the order of allocation of each of the methods to the samples participating in the study is determined. The way to use the table of random numbers is that the starting point is random 30 numbers will be chosen randomly (row or column) and the permutation assigned to each number will be noted down and the method of allocating 60 people to two intervention and control groups will be determined, Blinding description: The method of blinding will be that the questionnaires will be distributed and collected with the help of a researcher who is not aware of the control and intervention group, and also the statistician who analyzes the data will not know the groups and the patients' family caregivers. They will also be unaware of the control and intervention group. N/A Family caregivers of patients with spinal cord injury. Intervention 1: Intervention group: The participants of the intervention group, after completing the questionnaires, within 4 weeks (12 absentee and telephone sessions) in connection with topics including: 1- Anxiety and strategies to deal with it 2- Crisis and ways to deal with it 3- Urinary tract infection 4- Skin care and prevention of bed sores 5 - Training related to moving people with spinal cord injury 6- Proper nutrition is taught in the first six absentee and telephone sessions, and then in the next six absentee and telephone sessions, based on the checklist prepared by the researcher, the patients' family caregivers are followed up.At the end of 4 weeks, they will complete the anxiety and care burden questionnaires in person again. Intervention 2: Control group: They will first complete a informed consent form, demographic and medical information questionnaires, and a caregiver.In the control group, there is no intervention and the family caregivers of the patients will receive only the usual care and routine training as needed.At the end of 4 weeks, they will complete the anxiety and care burden questionnaires in person again.At the end of the study, in order to observe ethical considerations, a booklet will be provided to the control group in line with all the materials presented during the educational intervention. Yes - There is a plan to make this available What will be shared: Obtaining an official letter of introduction from Hazrat Fatemeh School of Midwifery and Nursing in Shiraz and obtaining permission from the officials of Shiraz University of Medical Sciences Obtaining written consent from the samples to participate in the study - Assuring the research units about the confidentiality of the information received - Participate freely and completely voluntarily in the research samples and considering the right to withdraw from the research - Creating a private environment for interviewing the patient and completing a questionnaire Provide the results of the research if desired by the training center where the researcher has sampled. When: After studying and printing the results To whom: The results of the research will be provided to the participants and relevant organizations upon request. Conditions: Obtaining permission from the relevant authorities in the faculty, university and welfare centers. Keeping participants' information confidential Where to obtain: Shiraz. Zand St., Shiraz School of Nursing and Midwifery Library. Mr. Ghasemi's library manager. Phone: 00987136474254 How to obtain: The request for the results will be sent to the library of Shiraz School of Nursing and Midwifery. It will be provided to them with the coordination done. Comments:
public Zahra Malazam
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
Shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3647 4254 molazemzah@yahoo.com Shiraz University of Medical Sciences scientific Zahra Malazam
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
Shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3647 4254 molazemzah@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Ability to access the phone (fixed and mobile) Willingness to collaborate in the study Care age between 18 and 65 years Caring for a person with any spinal cord injury Lack of mental illness and acute cognitive disorders in caregivers Have at least six months of care for a patient with a spinal cord injury Have the ability to understand, speak, and read and write Persian 18 years 65 years Both Incomplete completion of the questionnaire information Failure to answer the researcher's phone three times in a row Severe hearing problems Patient care Reluctance to continue cooperation Behavior Behavior Intervention group: The participants of the intervention group, after completing the questionnaires, within 4 weeks (12 absentee and telephone sessions) in connection with topics including: 1- Anxiety and strategies to deal with it 2- Crisis and ways to deal with it 3- Urinary tract infection 4- Skin care and prevention of bed sores 5 - Training related to moving people with spinal cord injury 6- Proper nutrition is taught in the first six absentee and telephone sessions, and then in the next six absentee and telephone sessions, based on the checklist prepared by the researcher, the patients' family caregivers are followed up.At the end of 4 weeks, they will complete the anxiety and care burden questionnaires in person again. Control group: They will first complete a informed consent form, demographic and medical information questionnaires, and a caregiver.In the control group, there is no intervention and the family caregivers of the patients will receive only the usual care and routine training as needed.At the end of 4 weeks, they will complete the anxiety and care burden questionnaires in person again.At the end of the study, in order to observe ethical considerations, a booklet will be provided to the control group in line with all the materials presented during the educational intervention. Anxiety score in Spielberger questionnaire. Timepoint: Assess the level of caregivers' anxiety before the intervention and after the intervention. Method of measurement: State-Trait Anxiety Inventory. Caregiver care load score. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Zarit Burden Inventory. Shiraz University of Medical Sciences Approved 2022-05-31 Ethics Committee of Shiraz University of Medical Sciences Namazi Square, Namazi Hospital, Fatemeh School of Nursing and Midwifery Shiraz Fars Iran (Islamic Republic of)