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IRCT20230303057600N1 IRCT 2023-07-08 Islamic Azad University A Comparative Study on the Effectiveness of Meaning-Centered Pain Coping Skills Training and Mindfulness-Based Stress Reduction in Breast Cancer Patients A Comparative Study on the Efficacy of Meaning-Centered Pain Coping Skills Training and Mindfulness-Based Stress Reduction on Pain Levels, Pain Self-efficacy, Death Anxiety, and Life Expectancy in Breast Cancer Patients 2023-04-10 anticipated 45 Complete https://irct.ir/trial/68975 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Teaching and comparing meaning-based pain coping skills with mindfulness-based stress reduction on their effects on the pain scale, pain self-efficacy, death anxiety, and life expectancy of patients with breast cancer for the first time in Iran, Randomization description: The randomization was performed by assigning a number from 1 to 45 to each participant, and the corresponding numbers were written on separate pieces of paper. The pieces of paper were then placed in one pouch. Additionally, 15 pieces of paper were labeled with the words "pain-focused coping skills," another 15 with "mindfulness-based stress reduction," and the remaining 15 with "control," which were also folded and placed in a separate pouch. A participant was asked to select one piece of paper from each pouch randomly, and based on the selected papers, the participant's group assignment and name were determined. N/A Breast Cancer. Intervention 1: Intervention Group 1: They receive instruction for meaning-oriented pain coping skills for four weeks, receiving a 45- to 60-minute group session every week based on Winger and colleagues' protocol (2021). First session plan: conducting the pretest, communicating, reviewing the intervention, meaning and pain, guided imagery to relax, reliving meaningful moments, at-home practice: guided imagery, questioning meaningful moments. Second session plan: sources of meaning, scheduling meaningful activities, activity cycle- rest to speed up the meaningful activities, at-home practice: guided imagery, meaningful activities, activity cycles- rest. The third session, plan: response to suffering (physical, emotional, and spiritual), coping phrases, brief relaxation, at-home practice: the previous skills, coping phrases, and brief relaxation. Fourth session plan: life legacy (the past, present, and future), goal setting based on value, problem-solving, and planning for practicing the current skills. Intervention 2: Intervention Group 2: They received instruction for mindfulness-based stress reduction for eight weeks, a 90-minute session per week based on Kabat-Zinn Protocol (2013). The first session plan: Communicating and familiarizing the treatment goals, introducing the intervention plan, intervention schedule, mindfulness as the way of living, mindful eating practices, body monitoring, discussion and feedback about practices. The second session plan: yoga, discussing the interaction between mindful activities, familiarizing at-home practices and body monitoring, discussing mindfulness (no conflict and contrast), introducing seated meditation, seated mediation guide (10 minutes), discussion and feedback about seated meditation. The third session plan: yoga, seated meditation (15 minutes), practices based on mindfulness (watching and listening mindfully) for five minutes, discussing mindful attitudes (not being judgmental and being graceful), dividing mindfully, introducing mindful dialogue as a practice, Muraqabah (meditation) guide, walking and breathing based on mindfulness (a 1-minute breathing space). The fifth session plan: Yoga; seated Muraqabah (mediation); mindful breathing, body, voices, and thoughts; discussing mindful attitudes (actively accepting and releasing); attending to problematic feelings and emotions. The sixths session plan: mindfulness of thoughts, breathing practices to manage anger, mindfulness and relationships, and meditation in nature. The seventh session plan: awareness and kindness, meditation. The eighth session plan: summarizing the intervention and discussing how patients use mindfulness practices practically to transform their lifestyle. Intervention 3: Control Group: No intervention (they only participate in the pretest-posttest stage of the course and do not receive any intervention. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared When: 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The use of educational protocols by citing the source and author of the article and the main author will be unimpeded Where to obtain: Mina Ansari minaansari995@gmail.com How to obtain: 6 months after the results of the study protocols will be published and the applicant can send her request using the registered email Comments:
public Mina Ansari
No. 3,The 8th Dashtestan Pasdaran Avenue
Tehran Iran (Islamic Republic of) 1947854911 +98 21 2288 3845 minaansari995@gmail.com Islamic Azad University scientific Mina Ansari
No. 3,The 8th Dashtestan Pasdaran Avenue
Tehran Iran (Islamic Republic of) 1947854911 +98 21 2288 3845 minaansari995@gmail.com Islamic Azad University Iran (Islamic Republic of) Age range between 30 to 60 years old Having at least a diploma Based on clinical findings and cytology studies and doctor's diagnosis, they are diagnosed with stage 3 breast cancer and more than 6 months have passed since the diagnosis of breast cancer. Subjects must be under chemotherapy or radiotherapy. Subjects should not participate in other psychotherapy courses simultaneously. They should obtain an adequate score in the Brief Pain Inventory as the baseline. 30 years 60 years Female Having used psychedelic drugs in the past three months. Any major mental disorder (such as psychosis, bipolar disorder, and chronic depression) or physical illness other than cancer. C50 Malignant neoplasm of breast Behavior Behavior N/A Intervention Group 1: They receive instruction for meaning-oriented pain coping skills for four weeks, receiving a 45- to 60-minute group session every week based on Winger and colleagues' protocol (2021). First session plan: conducting the pretest, communicating, reviewing the intervention, meaning and pain, guided imagery to relax, reliving meaningful moments, at-home practice: guided imagery, questioning meaningful moments. Second session plan: sources of meaning, scheduling meaningful activities, activity cycle- rest to speed up the meaningful activities, at-home practice: guided imagery, meaningful activities, activity cycles- rest. The third session, plan: response to suffering (physical, emotional, and spiritual), coping phrases, brief relaxation, at-home practice: the previous skills, coping phrases, and brief relaxation. Fourth session plan: life legacy (the past, present, and future), goal setting based on value, problem-solving, and planning for practicing the current skills. Intervention Group 2: They received instruction for mindfulness-based stress reduction for eight weeks, a 90-minute session per week based on Kabat-Zinn Protocol (2013). The first session plan: Communicating and familiarizing the treatment goals, introducing the intervention plan, intervention schedule, mindfulness as the way of living, mindful eating practices, body monitoring, discussion and feedback about practices. The second session plan: yoga, discussing the interaction between mindful activities, familiarizing at-home practices and body monitoring, discussing mindfulness (no conflict and contrast), introducing seated meditation, seated mediation guide (10 minutes), discussion and feedback about seated meditation. The third session plan: yoga, seated meditation (15 minutes), practices based on mindfulness (watching and listening mindfully) for five minutes, discussing mindful attitudes (not being judgmental and being graceful), dividing mindfully, introducing mindful dialogue as a practice, Muraqabah (meditation) guide, walking and breathing based on mindfulness (a 1-minute breathing space). The fifth session plan: Yoga; seated Muraqabah (mediation); mindful breathing, body, voices, and thoughts; discussing mindful attitudes (actively accepting and releasing); attending to problematic feelings and emotions. The sixths session plan: mindfulness of thoughts, breathing practices to manage anger, mindfulness and relationships, and meditation in nature. The seventh session plan: awareness and kindness, meditation. The eighth session plan: summarizing the intervention and discussing how patients use mindfulness practices practically to transform their lifestyle. Control Group: No intervention (they only participate in the pretest-posttest stage of the course and do not receive any intervention. Pain. Timepoint: Before intervention, immediately after intervention, and 45 days after intervention completion. Method of measurement: Brief pain questionnaire (BPI). Pain self-efficacy. Timepoint: Before intervention, immediately after intervention, and 45 days after intervention completion. Method of measurement: Pain self-efficacy questionnaire (PSEQ). Death anxiety. Timepoint: Before intervention, immediately after intervention, and 45 days after intervention completion. Method of measurement: Templer death anxiety questionnaire (DAS). Life expectancy. Timepoint: Before intervention, immediately after intervention, and 45 days after intervention completion. Method of measurement: Schneider life expectancy questionnaire (ََAHS). Islamic Azad University Approved 2023-02-15 Ethics Committee of Islamic Azad University, Sari branch Sari Islamic Azad University, On the 7th kilometer of Darya Road, Sari City, Mazandaran Province, Postal code 194-48164 Sari Mazandaran Iran (Islamic Republic of)