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IRCT20221118056532N1 IRCT 2022-12-18 Zanjan University of Medical Sciences Investigating of the effect of psychotherapy intervention on anxiety of gastrointestinal cancer patients and in Valiasr hospital oncology ward Zanjan in 2022 Investigating of the effect of psychotherapy intervention on anxiety of gastrointestinal cancer patients and in Valiasr hospital oncology ward Zanjan in 2022 2022-12-22 anticipated 50 Complete https://irct.ir/trial/66929 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To use the table of random numbers, we first determine the direction of reading the numbers in the table (for example, up, down, left or right), then even numbers are considered for the intervention group and odd numbers for the control group. In the next step, the researcher puts his hand on one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups, and this should continue until the samples are assigned to two groups, Blinding description: The study will be double-blind, so that the patients and the researcher responsible for data analysis will not have any intervention or control information regarding the allocation of people to groups. To blind the patients, we will provide a series of trainings and routine care to the control group. For the purpose of blinding the statistician who is responsible for data analysis, the intervention and control groups will be coded and provided to him for analysis without mentioning the intervention and control group. N/A Condition 1: Anxiety. Condition 2: cancer. Intervention 1: Intervention group: will participate in 6 psychotherapy sessions for 30 to 60 minutes and 2 sessions per week. The first session: supportive psychotherapy and its importance, getting to know the principles of the group, getting to know more about the members and getting to know the disease. The second session: discussion and exchange of opinions of members about cancer and its impact on life. Session 6-3: Focus on members' concerns and problems. Intervention 2: Control group: The control group will receive regular training and care during the study period. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Kazem Ashrafi
Shahid Beheshti Hospital, Arg Square, Zanjan
Zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 2403 Kazemashrafi78@gmail.com Zanjan University of Medical Sciences scientific Kazem Ashrafi
Shahid Beheshti Hospital, Arg Square, Zanjan
Zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 4001 Kazemashrafi78@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) volunteering to enter the study, Age above 18 years Having one of the gasterointestinal cancer 18 years no limit Both Having diagnosed psychological illness including anxiety and depression Participation in psychotherapy classes death of a loved one; Divorced in the last 6 months F06.4 D70.1 Anxiety disorder due to known physiological condition Agranulocytosis secondary to cancer chemotherapy Behavior Behavior Intervention group: will participate in 6 psychotherapy sessions for 30 to 60 minutes and 2 sessions per week. The first session: supportive psychotherapy and its importance, getting to know the principles of the group, getting to know more about the members and getting to know the disease. The second session: discussion and exchange of opinions of members about cancer and its impact on life. Session 6-3: Focus on members' concerns and problems. Control group: The control group will receive regular training and care during the study period. Depression. Timepoint: Before starting the study - 6 sessions. Method of measurement: BDI-II. Anxiety and depression score. Timepoint: Before the intervention - six sessions. Method of measurement: BDI-II,Depression questionnaire. Zanjan University of Medical Sciences Approved 2022-10-25 National Committee of ethics in biomedical research Ark square, Hospitalof Shahid Beheshti Educational & Treatment Center of Shahid Beheshti Zanjan Zanjan Iran (Islamic Republic of)