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IRCT20260212068841N1 IRCT 2026-06-20 Babol University of Medical Sciences Effect of Mindfulness on self-efficacy and rumination and resilience The effect of mindfulness-based cognitive therapy on self-efficacy and rumination and resilience on family caregiver of patient with cancer 2026-06-02 anticipated 90 Complete https://irct.ir/trial/89704 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Patients will be randomly assigned to two treatment and control groups using a block-wise random allocation method of equal size. The random sequence will be generated using a block-wise allocation method with a block size of four by Random Allocation software. Allocation concealment will be performed using sealed, numbered opaque envelopes. Each random sequence will be written on separate cards and the cards will be placed in sealed, opaque envelopes. These envelopes will be numbered sequentially and placed in a special box. When each participant enters, one of the envelopes will be opened in order and the desired group will be determined. This process will be carried out to ensure that the random allocation remains hidden until the participant enters the study, which is in accordance with CONSORT recommendations, a method to prevent bias in the randomization process. N/A self-efficacy, rumination and resilience. Intervention 1: Intervention group: Mindfulness techniques including conscious breathing, body scan, sitting meditation, conscious seeing and listening, and conscious walking will be taught in eight ninety-minute training sessions for eight consecutive weeks (one session per week) in groups of fifteen people. All educational materials provided will be presented in the sessions after the supervision and review of a psychiatrist. For the intervention group, the training program will be held in a group in the doctor's room of Imam Sajjad Hospital and the specialized clinic of an oncologist. The intervention will be carried out in the form of training and counseling. After each session, audio and video files, educational booklets, and weekly assignments will be provided to the participants. Intervention 2: Control group: They will receive no educational intervention during the intervention period. 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 I do not decide yet.
public Reza Delfani
Babol University of Medical Science, Ganj Afrooz Ave
Babol Iran (Islamic Republic of) 4754131045 +98 991 225 5614 rdadlf3@gmail.com Babol University of Medical Sciences scientific Abbas Shamsalinia
Nursing faculty of ramsar, Mottahari Ave
Ramsar Iran (Islamic Republic of) 4691714141 +98 11 5522 5151 abbasshamsalinia@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Age 18 years and over Being literate Fluency in Persian Having a relative or causal relationship with the patient Caring for just one patient Not receiving wages Not being a member of the medical staff Caring for a patient with cancer for at least the past two months Failure to participate in similar training courses upon entering the study 18 years no limit Both History of mental health problems such as anxiety disorders and depression, as reported by caregivers Unwillingness to participate in the study Behavior Other Intervention group: Mindfulness techniques including conscious breathing, body scan, sitting meditation, conscious seeing and listening, and conscious walking will be taught in eight ninety-minute training sessions for eight consecutive weeks (one session per week) in groups of fifteen people. All educational materials provided will be presented in the sessions after the supervision and review of a psychiatrist. For the intervention group, the training program will be held in a group in the doctor's room of Imam Sajjad Hospital and the specialized clinic of an oncologist. The intervention will be carried out in the form of training and counseling. After each session, audio and video files, educational booklets, and weekly assignments will be provided to the participants. Control group: They will receive no educational intervention during the intervention period. Self-efficacy. Timepoint: Before the start of the mindfulness training sessions, immediately, and two months after completing the eight mindfulness training sessions. Method of measurement: scherrer General Self-Efficacy Questionnaire. Rumination. Timepoint: Before the start of the mindfulness training sessions, immediately, and two months after completing the eight mindfulness training sessions. Method of measurement: Hoeksma and Maru Rumination Questionnaire. Resilience. Timepoint: Before the start of the mindfulness training sessions, immediately, and two months after completing the eight mindfulness training sessions. Method of measurement: Connor and Davidson Resilience Scale. Babol University of Medical Sciences Approved 2026-04-22 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz Ave Babol Mazandaran Iran (Islamic Republic of)