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IRCT20230620058544N1 IRCT 2023-06-27 Gonabad University of Medical Sciences The effect of virtual training of mindfulness based cognitive therapy on pain severity and quality of life in women treated with breast cancer The effect of virtual training of mindfulness based cognitive therapy on pain severity and quality of life in women treated with breast cancer 2023-07-22 anticipated 54 Complete https://irct.ir/trial/70803 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Type of study: randomized clinical trial with a pre-test-post-test design with a control group. First, people will be randomly divided into two test and control groups and will enter the study. Both groups complete the quality of life and pain intensity questionnaire before the intervention. No action is taken in the control group and the experimental group is subjected to the intervention of cognitive therapy training based on mindfulness. One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared, Randomization description: Sampling will be done in an easy and purpose-based way according to the criteria for entering and exiting the research community. People will be selected from among the women undergoing primary breast cancer treatment in Isfahan treatment centers who meet the entry criteria, and then they will be randomly assigned to the intervention and control groups using four permutation blocks. Six possible states (BABA, ABBA, BAAB, AABB ABAB, BBAA) are listed and by throwing a dice, the number of blocks will be randomly selected until a sufficient number of samples, and people will be placed in two intervention (A) and control (B) groups. N/A Breast Cancer. Intervention 1: Intervention group: Before the start of the intervention, the virtual questionnaire of quality of life and brief pain intensity questionnaire will be completed by the test and control group. The test group is subjected to the intervention of cognitive therapy training based on mindfulness in virtual form during 8 sessions of 90 minutes (once a week) in the form of lectures and questions and answers. The first and last meeting will be held online on the Zinomite platform, and other meetings will be held offline through the formation of a group on the Yes social network in the form of sending a video. Also, in order to provide guidance and answer the questions of the participants, audio and video calls will be made during the week.he training program consists of two parts: a training course provided by the researcher (after training under the supervision of an experienced psychologist in mindfulness interventions), the other is a 45-minute home exercise (after each virtual session for 6 days a week). One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared. Intervention 2: Control group: Before the start of the intervention, the virtual questionnaire of quality of life and brief pain intensity questionnaire will be completed by the test and control group. There is no intervention on the control group. One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared. Finally, in order to comply with the ethical principles, the people in the control group who want individual counseling will receive the training program. 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 Arefeh Ebrahimi
Side of the Asian road
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 arefehebrahimi4@gmail.com Gonabad University of Medical Sciences scientific Arefeh Ebrahimi
Side of the Asian road
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 arefehebrahimi4@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) 1-Diagnosis of breast cancer (phase I and II) 2- Age range between 18 and 60 years 3-Consent to participate in the study 4- Ability to read and write 5- Absence of speech, hearing and vision problems 6-Access to social networks 7- Absence of active mental disorder 18 years 60 years Female 1-Diagnosis of metastatic breast cancer based on the opinion of an oncologist 2-Patient withdrawal from the study 3-Absence of more than two sessions in educational sessions C50 Malignant neoplasm of breast Other Other Intervention group: Before the start of the intervention, the virtual questionnaire of quality of life and brief pain intensity questionnaire will be completed by the test and control group. The test group is subjected to the intervention of cognitive therapy training based on mindfulness in virtual form during 8 sessions of 90 minutes (once a week) in the form of lectures and questions and answers. The first and last meeting will be held online on the Zinomite platform, and other meetings will be held offline through the formation of a group on the Yes social network in the form of sending a video. Also, in order to provide guidance and answer the questions of the participants, audio and video calls will be made during the week.he training program consists of two parts: a training course provided by the researcher (after training under the supervision of an experienced psychologist in mindfulness interventions), the other is a 45-minute home exercise (after each virtual session for 6 days a week). One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared. Control group: Before the start of the intervention, the virtual questionnaire of quality of life and brief pain intensity questionnaire will be completed by the test and control group. There is no intervention on the control group. One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared. Finally, in order to comply with the ethical principles, the people in the control group who want individual counseling will receive the training program. People's scores in Arnson's quality of life questionnaire. Timepoint: Checking the quality of life of the participants before the intervention and one week after the end of the intervention. Method of measurement: Arnson quality of life questionnaire. People's scores in the Brief Cleveland Pain Intensity Questionnaire. Timepoint: Examining the pain intensity of the participants before the start of the intervention and one week after the end of the intervention. Method of measurement: Brief Cleveland Pain Intensity Questionnaire. Gonabad University of Medical Sciences Approved 2023-05-03 Ethics committee of Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Side of the Asian road,Gonabad Gonabad Razavi Khorasan Iran (Islamic Republic of)