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IRCT20210515051300N1 IRCT 2021-07-20 Mashhad University of Medical Sciences The effectiveness of emotion regulation skills training on gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome The effectiveness of emotion regulation skills training on gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome 2021-07-19 anticipated 48 Complete https://irct.ir/trial/57576 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The permuted random blocking method is used to do randomization. In this method, 12 blocks of 4 will be randomly selected from a combination of letters A and B. These blocks are as follows AABB, ABBA, BBAA, BAAB, ABAB, and BABA. Allocating the letters A and B to the intervention and control groups will be done randomly before randomization and the data analyst will be unaware of the intervention and control groups. The researcher, having a list of people (a list of 48 people who are going to participate in the project), assigns a numeric code to each person. It then offers the anonymous list of members (containing only the numeric code) to the sample assignor to the groups. First, the sample assignor organizes the selected blocks as described, writes them on separate sheets of paper (12 separate sheets), and places them in sealed envelopes. Then s/he randomly selects the envelopes and, based on the previously selected codes, A and B, determines the numerical code number of the individuals assigned to A and B interventions and provides it to the researcher. For instance, if the BABA block is selected first, the first person on the list will be assigned to group B, the second person to group A, the third person to group B, and the fourth person to group A. Likewise, participants 5 to 48 will be assigned to groups A and B. N/A Gastrointestinal sensitivity, disease perception, anxiety sensitivity and quality of life in patients with irritable bowel syndrome. Intervention 1: 8 sessions of emotion regulation skills training are held twice a week for 90 minutesThese meetings are based on the Gross protocol.The content of the sessions includes familiarity with the concept of emotion and types of emotions,Talk about emotion performance and its benefits, introduce the Gross emotion regulation model and learning how to regulate emotion based on this protocol. Intervention 2: Control group: They do not receive any intervention. 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 Maintaining confidentiality
public Samane Soltanabadi
Khaghani19
Mashhad Iran (Islamic Republic of) 66373_ 91949 +98 51 3734 4825 samane.soltanabadi@gmail.com Mashhad University of Medical Sciences scientific Samane Soltanabadi
Khaghani19
Mashhad Iran (Islamic Republic of) 66373_91949 +98 51 3734 4825 samanesoltanabadi@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Irritable bowel syndrome with diagnosis of gastroenterologist and diagnostic criterion Romm-III Age 20 to 55 years Have at least 8 literacy classes Having informed consent to enter the research Have at least some insight into the psychological cause of your illness 20 years 55 years Both Severe physical condition (such as bleeding and severe pain) Acute psychiatric illness that makes it difficult to participate in treatment (such as psychotic disorders, bipolar disorder, major depression, suicide attempt) Absence for more than two sessions. K58.9, k58 Irritable bowel syndrome with diarrhoea, Irritable bowelsyndrome without diarrhoea Other N/A 8 sessions of emotion regulation skills training are held twice a week for 90 minutesThese meetings are based on the Gross protocol.The content of the sessions includes familiarity with the concept of emotion and types of emotions,Talk about emotion performance and its benefits, introduce the Gross emotion regulation model and learning how to regulate emotion based on this protocol. Control group: They do not receive any intervention. Gastrointestinal allergies. Timepoint: Beginning and end of the study. Method of measurement: Labas Digestive Sensitivity Questionnaire et al. Perception of disease. Timepoint: Beginning and end of the study. Method of measurement: Disease Perception Broadbent et al. Anxiety sensitivity. Timepoint: Beginning and end of the study. Method of measurement: Taylor and Cox Anxiety Sensitivity Questionnaire. Quality of Life. Timepoint: Beginning and end of the study. Method of measurement: Patrick and Dorsman Quality of Life Questionnaire. . Approved 2021-04-13 Ethics Committee of Mashhad University of Medical Sciences Khaghani 19, No. 192 Mashhad Razavi Khorasan Iran (Islamic Republic of)