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IRCT20210613051569N1 IRCT 2021-07-12 University of social welfare and rehabilitation sciences The effect of implementing pain self-management program on pain self-efficacy, pain intensity and pain acceptance in the elderly with chronic low back pain referred to clinics affiliated to Babol University of Medical Sciences in 2020 The effect of implementing pain self-management program on pain self-efficacy, pain intensity and pain acceptance in the elderly with chronic low back pain referred to clinics affiliated to Babol University of Medical Sciences in 2020 2021-07-23 anticipated 100 Complete https://irct.ir/trial/56892 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Unit randomization is done by block method with a block size of 4. For each of the 6 possible scenarios for the quadruple block, the numbers are assigned as follows AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6).The numbers between 1 and 6 are selected, and the treatment allocation list is determined according to each number..In this method, the cans are numbered in a random sequence. Inside the boxes, the desired intervention or a sheet on which the random allocation is written is provided to the executor with the condition that the boxes are completely sealed. Finally, the researcher assigns patients to the control and intervention groups based on patients' admission orders.Tools: Create random sequences of 4 random blocks Concealment to execute random sequences on study participants will be done. How to make blocks: Randomly select the block and read the letters from right to left. Hiding will be done by the method of cans that are numbered in random sequence. The cans are the same weight and shape and will be prepared by an independent researcher. N/A chronic low back pain. Intervention 1: Intervention group:After randomly dividing patients into intervention and control groups, the intervention group first completes the questionnaires and then is scheduled to receive self-management program training. Educational items include: pain control methods that include physical methods, psychological methods and medication methods and exercise. It should be noted that the educational content of the self-management program is in the form of a CD and an educational booklet whose content has been approved by experts, professors of orthopedics and neurosurgeons of Babol University of Medical Sciences, professors of geriatrics and physiotherapy, University of Rehabilitation Sciences and Social Health. Will be prepared and provided to patients in the intervention group. Patients will be given exercises to perform functional exercises and other sports exercises in coordination and under the supervision of a physiotherapist. Immediately after the intervention, the questionnaires will be completed for the second time and then the intervention group will be given a month to implement the training given at home and will be contacted by phone to follow up with patients. At the end of one month, the questionnaires are completed again (for the third time) by the members of the intervention group. Intervention 2: No intervention was performed on the control group. The control group will receive only routine care. This group will complete the questionnaires in parallel with the intervention group before, after and one month after the intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Zahra Maghdoori
Ganj Afrooz St., Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4715766721 +98 11 3219 2034 zahra9482@yahoo.com University of social welfare and rehabilitation sciences scientific Farahnaz Mohammadi Shahbolaghi
Department of Nursing, University of Rehabilitation Sciences and Social Health
Tehran Iran (Islamic Republic of) 1985713834 +98 21 2218 0036 f.mohammadi@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 60 years Capable of reading and writing Have cognitive health based on the Abbreviated Mental Test (AMT) criteria Willing to participate in the study Live in the city of Babol and related countryside areas Back pain for more than 3 months (12 weeks) Capable of exercise according to a physicians opinion 60 years no limit Both Any history of back surgery Any mobility disorders and disability Any history of psychiatric disorders Any history of malignancies Any history of participation in similar interventions M54.5 Low back pain Rehabilitation N/A Intervention group:After randomly dividing patients into intervention and control groups, the intervention group first completes the questionnaires and then is scheduled to receive self-management program training. Educational items include: pain control methods that include physical methods, psychological methods and medication methods and exercise. It should be noted that the educational content of the self-management program is in the form of a CD and an educational booklet whose content has been approved by experts, professors of orthopedics and neurosurgeons of Babol University of Medical Sciences, professors of geriatrics and physiotherapy, University of Rehabilitation Sciences and Social Health. Will be prepared and provided to patients in the intervention group. Patients will be given exercises to perform functional exercises and other sports exercises in coordination and under the supervision of a physiotherapist. Immediately after the intervention, the questionnaires will be completed for the second time and then the intervention group will be given a month to implement the training given at home and will be contacted by phone to follow up with patients. At the end of one month, the questionnaires are completed again (for the third time) by the members of the intervention group. No intervention was performed on the control group. The control group will receive only routine care. This group will complete the questionnaires in parallel with the intervention group before, after and one month after the intervention. Pain self-efficacy. Timepoint: Before the beginning of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Pain self-efficacy questionnaire. Pain intensity. Timepoint: Before the beginning of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Visual scale of pain. Pain acceptance. Timepoint: Before the beginning of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Chronic Pain Acceptance Questionnaire. University of social welfare and rehabilitation sciences Approved 2021-05-12 Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences Evin, Daneshjoo Blvd., Koodkiar impasse Tehran Tehran Iran (Islamic Republic of)