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IRCT20171031037145N2 IRCT 2020-11-21 Artesh University of Medical Sciences effect of stress reduction on chronic pain Effectiveness of Mindfulness-Based Stress Reduction (MBSR) on pain intensity, anxiety, depression and quality of life of patients with chronic pain: Randomized Clinical Trials 2019-04-21 anticipated 50 Complete https://irct.ir/trial/52402 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the announcement and invitation that was installed in Imam Reza hospital to participate in this research, the applicants called and expressed their desire to participate in the research. After the initial screening, patients were informed about the study and the form of informed consent were given to them. If the form is approved and signed, the therapist will conduct a structured clinical interview for DSM5 (SCID-5) and if they complied with the inclusion and exclusion criteria, the patient would enter the study as a research sample. Based on this, 50 patients were selected. After selecting patients and randomly assigning them to experimental and control groups. Patients were randomly assigned to two groups of 25 using 4 and 6 blocks with a ratio of 1: 1. Random allocation sequences of patients in both groups were performed using Randomizer software. Consecutive opaque numbered envelopes were used to conceal the allocation, Blinding description: The data analyzer did not know the names of the study groups, and the groups were numbered. N/A Chronic Pain. Intervention 1: Intervention group: The MBSR-based group intervention was based on the 8-session John Kabat-Zin approach, with a duration of 1.5 hours per session. The content of the MBSR 8 sessions was as follows: Session 1: Communication skills and conceptualization, the need to use mindfulness training, providing explanations about the auto-guidance system. Session 2: Review of last week's homework, body scan, meditation exercises, mindfulness-based breath training (MBRT).Session 3: Review of last week's homework, sitting meditation, practice review, three-minute breathing space training. Session 4: Review of last week's homework, a five-minute practice of "seeing or hearing," mindfulness-based breath training and body scan. Session 5: Review of last week's homework, breathing exercises, sitting meditation (awareness of breathing, body, sounds, and thoughts), explanations about stress and its relationship to pain, awareness of the effect of pleasant and unpleasant events on feelings, thoughts and body feelings. Session 6: Review of last week's homework, vigilant yoga, discussion of different views of thoughts or substitute thoughts, sitting meditation (Mindfulness of sounds and thoughts).Session 7: Review of last week's homework, sleep hygiene, repeating the homework of the previous sessions, and providing a list of fun activities. Session 8: Review of last week's homework, body scan, summing up the sessions, Check out and discuss about the programs and continuing the exercises for management of pain. Intervention 2: Control group: The control group did not receive any intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Disagreement of the supervisor of this research
public Farshad Sheybani
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 sheybani.f@iums.ac.ir Iran University of Medical Sciences scientific Farshad Sheybani
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 sheybani.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) presence of at least one symptom of pain without any specific medical reason for at least 6 months age between 18 and 60 years the education level of at least middle school (8th grades) 18 years 60 years Both substance abuse severe psychiatric problems such as psychosis R52.1 Chronic intractable pain Behavior N/A Intervention group: The MBSR-based group intervention was based on the 8-session John Kabat-Zin approach, with a duration of 1.5 hours per session. The content of the MBSR 8 sessions was as follows: Session 1: Communication skills and conceptualization, the need to use mindfulness training, providing explanations about the auto-guidance system. Session 2: Review of last week's homework, body scan, meditation exercises, mindfulness-based breath training (MBRT).Session 3: Review of last week's homework, sitting meditation, practice review, three-minute breathing space training. Session 4: Review of last week's homework, a five-minute practice of "seeing or hearing," mindfulness-based breath training and body scan. Session 5: Review of last week's homework, breathing exercises, sitting meditation (awareness of breathing, body, sounds, and thoughts), explanations about stress and its relationship to pain, awareness of the effect of pleasant and unpleasant events on feelings, thoughts and body feelings. Session 6: Review of last week's homework, vigilant yoga, discussion of different views of thoughts or substitute thoughts, sitting meditation (Mindfulness of sounds and thoughts).Session 7: Review of last week's homework, sleep hygiene, repeating the homework of the previous sessions, and providing a list of fun activities. Session 8: Review of last week's homework, body scan, summing up the sessions, Check out and discuss about the programs and continuing the exercises for management of pain. Control group: The control group did not receive any intervention. Anxiety: In this study, the severity of anxiety was measured using the Beck Anxiety Inventory. Timepoint: Before and after the intervention. Method of measurement: Beck Anxiety Inventory. Quality of life: Quality of life is a person's perception of the state of life in the field of culture and value system in which she lives, and this concept is related to goals, expectations, criteria and important matters. Timepoint: Before and after the intervention. Method of measurement: World Health Organization Quality of Life-BREF (WHOQOL-BREF). Pain intensity: An unpleasant sensory and psychological experience associated with possible or actual tissue damage. Timepoint: Before and after the intervention. Method of measurement: numeric pain rating scale. Depression: Depression is a transient decrease or persistence of neuropsychological stress that manifests itself as a physical component (such as headache, fatigue, insomnia, constipation, hypotension) and a psychological component (such as feelings of hopelessness, sadness, inferiority). Timepoint: Before and after the intervention. Method of measurement: Beck Depression Inventory-II (BDI-II). Artesh University of Medical Sciences Approved 2018-12-09 Ethics committee of AJA University of Medical Sciences End of Etemadzadeh Street, West Fatemi Street , Tehran, Iran Tehran Tehran Iran (Islamic Republic of)