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IRCT20200831048567N1 IRCT 2020-10-28 Iran University of Medical Sciences The effect of expressive writing on anxiety sensitivity and severity of symptoms in patients with irritable bowel syndrome The effect of expressive writing on anxiety sensitivity and severity of symptoms in patients with irritable bowel syndrome 2019-10-07 anticipated 72 Complete https://irct.ir/trial/50701 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Continuous method was used for selection and double blind method was used to allocate the participants to the study and control groups. In this way, the researcher writes different states of the two groups (4 modes: 1. control-intervention; 2. Intervention – control; 3. Intervention – intervention; 4. Control - control) on 4 note cards and puts each in an envelope. These envelopes were placed in a box and the researcher did not know in which group the participant would be placed until the card was chosen. Before assigning, encountering the research units, the researcher removed one of the envelopes from the box to determine which group of patients were included in the study, respectively. This process continued until all 4 cards were taken out of the box, then the cards were returned to the box and the random selection of cards was repeated. The sampling process continued until the desired sample volume was completed and then stopped, Blinding description: The study was single blinded; individuals were not aware of the study hypotheses or that there were writing condition. Participants were aware that they were consenting to take part in a writing intervention that could reduce their symptoms. N/A Irritable bowel syndrome. Intervention 1: Intervention group: Patients with irritable bowel syndrome who Receive expressive writing from a researcher. Intervention 2: Control group: Patients with irritable bowel syndrome who receive routine pre-discharge training from ward staff. Yes - There is a plan to make this available What will be shared: Research findings and results file (only part of the data such as information about the main outcome or the like can be shared). When: Start of access period after the publication of the article (late 1399) To whom: Researchers working in academic and scientific institutions Conditions: In this study, no studies and/or judgments were made about patients 'writings as well as their content analysis. only the information related to the participants' unidentifiable questionnaire file was statistically analyzed (using SPSS software version 16 with a level of significance of 0.05) in two sections of descriptive and inferential statistics. The findings and results of the present study will be allowed to be used in other related research at a broader level and reference in other studies. Where to obtain: 1. Dr. Alice Khachian / E-mail address khachian.a@iums.ac.ir 2. Marzieh Borjian (Master student of Internal Surgery Nursing, Iran University of Medical Sciences) / E-mail address: M.Borjian@yahoo.com Address of the Faculty of Nursing and Midwifery: Tehran, Vali Asr St., above Vanak Sq., Rashid Yasemi St. Faculty Contact Number: 021-43651000 / Postal Code: 1996713883 / Fax: 882011978 How to obtain: To receive the documentation file of the present study, applicants can send their request to use and determine how the findings of this research are used in their study, to the above-mentioned e-mail addresses. Will be provided to them. Comments:
public Marzieh Borjian
No 1, Sholevar Ave., South Kargar Street., Enghlab Square
Tehran Iran (Islamic Republic of) 1313935196 +98 21 8879 4302 M.Borjian@yahoo.com Iran University of Medical Sciences scientific Dr. Alice Khachian
School of Nursing & Midwifery Rashid Yasemi St. Vali Asr St.Tehran- Iran
Tehran Iran (Islamic Republic of) 199613883 +98 21 8879 4302 khachian.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having IBS based on a doctor's diagnosis Satisfaction and willingness of patients to participate in the study Having symptoms classified based on the irritable bowel syndrome Severity Index (SI-IBS); in the mild, moderate, or severe scale The diagnosis was made at least 3 months ago Be literate enough to write and complete questionnaires The patient is physically and mentally fit to write Does not suffer from acute mental disorders based on the doctor's diagnosis and registration Does not take anti-anxiety medications for the past 3 months based on the patient's record At the same time, participants do not have other functional or structural gastrointestinal disorders based on the patient's record 18 years 65 years Both Diagnosis of any disease during the study by the treating physician Patient’s dissatisfaction or unwillingness to cooperation or to continue with the study Patients who do not participate in pre-test or post-test evaluations Not writing in the booklet more than 2 times or a total of 4 sessions Hospitalization of the patient due to exacerbation of gastrointestinal symptoms during the study K58 Irritable bowel syndrome Other Other Intervention group: Patients with irritable bowel syndrome who Receive expressive writing from a researcher. Control group: Patients with irritable bowel syndrome who receive routine pre-discharge training from ward staff. Rate of anxiety sensitivity. Timepoint: Before the intervention and 1 month after the intervention (written emotional expression). Method of measurement: Based on the score of (0-144) Revised Anxiety Sensitivity Index (ASI-R). Severity of gastrointestinal symptoms. Timepoint: Before the intervention and 1 month after the intervention (written emotional expression). Method of measurement: Obtaining a score between 75-500 Based on Irritable Bowel Syndrome Severity Index (IBS-SI) Questionnaire. Anxiety Sensitivity Score in the Revised Anxiety Sensitivity Index (ASI-R) Questionnaire. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: Revised Anxiety Sensitivity Index (ASI-R) Questionnaire. Gastrointestinal symptom severity score in Irritable Bowel Syndrome Severity Index (IBS-SI). Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: Irritable Bowel Syndrome Severity Index (IBS-SI) Questionnaire. Iran University of Medical Sciences Approved 2019-06-30 Ethics committee of Iran University of Medical Sciences No 1, Sholevar Ave., South Kargar Street., Enghlab Square Tehran Tehran Iran (Islamic Republic of)