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IRCT20240203060885N1 IRCT 2024-02-20 Mashhad University of Medical Sciences Investigating the effectiveness of psychological education of the patient and spouse in people with obstructive sleep apnea following the CPAP device, improving sleep quality and reducing daily sleepiness Investigating the effectiveness of psychological education of the patient and spouse in people with obstructive sleep apnea following the CPAP device, improving sleep quality and reducing daily sleepiness 2024-02-13 anticipated 32 Complete https://irct.ir/trial/75299 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, permutation blocks method was used to generate the sequence of random assignment of people to the studied groups. Random allocation sequence of people was done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. In this study, there are six blocks AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6). One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second people are assigned to group A, and the third and fourth people are assigned to group B, and this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers, Blinding description: The participants in this research do not know about the sampling method and the members of the control group and only receive the intervention. N/A Patients with obstructive sleep apnea. Intervention 1: Intervention group: This group includes 17 patients with their partner, the affected patient has used the CPAP machine for one month, and after one month, intervention sessions (5 sessions) will be held for each person in person or online.The content of the sessions will be based on the cognitive-behavioral approach. In this way, one session of psychoeducation, two sessions of working on false beliefs of the patient and partner about apnea and the use of (cognitive) device, and two sessions will be behavioral.After finishing the sessions, the patient will use the device again for one month to determine the effectiveness of the intervention sessions. Intervention 2: Intervention group: This group includes 17 patients without a partner, the affected patient has used the CPAP machine for one month, and after one month, intervention sessions (5 sessions) will be held for the patient in person or online. The content of the sessions will be based on the cognitive-behavioral approach.In this way, one session of psychoeducation, two sessions of working on the patient's false beliefs about apnea and the use of the (cognitive) device, and two sessions will be behavioral. After finishing the sessions, the patient will use the device again for one month to determine the effectiveness of the intervention sessions. Intervention 3: Control group: The control group includes 17 patients along with their partner, the affected patient used the CPAP machine for one month, and after one month, all the content related to the intervention sessions was given to the patient and partner in the form of brochures without conducting the sessions. to be read weekly. After five weeks, the patient will use the device again for one month to determine the effectiveness of the intervention sessions. 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 further information
public Mahdiye Faramarzi Moghaddam
Hedayat St., 2.1 Hedayat, No. 83, second floor
Mashhad Iran (Islamic Republic of) 9194873999 +98 991 073 6552 Faramarzimahdiye01@gmail.com Mashhad University of Medical Sciences scientific Mahdiye Faramarzi Moghaddam
Hedayat St., 2.1 Hedayat, No. 83, second floor
Mashhad Iran (Islamic Republic of) 9194873999 +98 991 073 6552 faramarzimahdiye01@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with obstructive sleep apnea patients who want to use CPAP device completing questionnaires related to sleep quality and daily sleepiness marriage no limit no limit Both suffering from severe mental illnesses (psychotic, bipolar) G47.3 Sleep apnea N/A N/A N/A Intervention group: This group includes 17 patients with their partner, the affected patient has used the CPAP machine for one month, and after one month, intervention sessions (5 sessions) will be held for each person in person or online.The content of the sessions will be based on the cognitive-behavioral approach. In this way, one session of psychoeducation, two sessions of working on false beliefs of the patient and partner about apnea and the use of (cognitive) device, and two sessions will be behavioral.After finishing the sessions, the patient will use the device again for one month to determine the effectiveness of the intervention sessions. Intervention group: This group includes 17 patients without a partner, the affected patient has used the CPAP machine for one month, and after one month, intervention sessions (5 sessions) will be held for the patient in person or online. The content of the sessions will be based on the cognitive-behavioral approach.In this way, one session of psychoeducation, two sessions of working on the patient's false beliefs about apnea and the use of the (cognitive) device, and two sessions will be behavioral. After finishing the sessions, the patient will use the device again for one month to determine the effectiveness of the intervention sessions. Control group: The control group includes 17 patients along with their partner, the affected patient used the CPAP machine for one month, and after one month, all the content related to the intervention sessions was given to the patient and partner in the form of brochures without conducting the sessions. to be read weekly. After five weeks, the patient will use the device again for one month to determine the effectiveness of the intervention sessions. Patients with obstructive sleep apnea who use a CPAP machine. Timepoint: The measurement is done before the start of the intervention, immediately after the end of the intervention and eight weeks after the intervention. Method of measurement: Using the Petersburg Sleep Quality Questionnaire and Epworth Daily Sleepiness Questionnaire. Improving sleep quality. Timepoint: The measurement is done before the start of the intervention, immediately after the end of the intervention and eight weeks after the intervention. Method of measurement: Using the Petersburg Sleep Quality Questionnaire and the Epworth Daily Sleepiness Questionnaire. Reducing daily sleepiness. Timepoint: The measurement is done before the start of the intervention, immediately after the end of the intervention and eight weeks after the intervention. Method of measurement: Using the Petersburg Sleep Quality Questionnaire and the Epworth Daily Sleepiness Questionnaire. Mashhad University of Medical Sciences Approved 2024-02-04 Ethics Committee of Mashhad University of Medical Sciences East Hedayat St., Hedayat 2.1, plauqe. 83, second floor Mashhad Razavi Khorasan Iran (Islamic Republic of)