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IRCT20110629006917N6 IRCT 2022-08-19 Iran University of Medical Sciences The effect of emotional self- disclosure on disease activity, health status and sexual function in women with rheumatoid arthritis The effect of emotional self- disclosure on disease activity, health status and sexual function in women with rheumatoid arthritis in comparison with control group 2022-07-30 anticipated 72 Complete https://irct.ir/trial/64809 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: The selection of sample people will be done in a continuous method and the allocation of the samples to the test group (a) or control (b) will be done by the double block method. In this way, a person outside the research team will write different states of two groups (4 states in total: 1-A, B, 2-B, A, 3-A, A, and 4-B, B) on 4 note cards and will put each one in a closed envelope so that the researcher doesn't know the order of placement of people in two groups before opening the envelopes. N/A Rheumatoid arthritis. Intervention 1: Intervention group: First, the participants will complete questionnaires including demographic characteristic, clinical status of the disease, FSFI (Female Sexual Function Index) and AIMS2-SF (health status questionnaire). Also before the study, the disease activity of both groups will be measured using the DAS-28 tool by a rheumatologist. Then participants will receive a notebook to writing their feelings freely. In this study, the researcher will give complete oral explanations about the intervention implementation to participants in intervention group. Also, a written guide of the intervention implementation method will be given to them. The intervention group participants will express their feelings freely and voluntarily at home and preferably in a private room, once a day and 4 times a week for 4 weeks. Free writing of emotions will be regardless of spelling and compositional points. During the study period, the writing process of the patients will be followed up by the researcher at the end of each week via phone call. After the completion of the intervention, the study questionnaire will be sent via WhatSapp and email and participants will completed them again. Intervention 2: Control group: First, the participants will complete questionnaires of demographic information and clinical status of the disease, FSFI (Female Sexual Function Index) and AIMS2-SF (health status questionnaire) before studying the disease activity of both group using the DAS-28 will be measured. The control group will receive only routine care after the pre-test. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Elnaz Ashrafpour
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi Street, Vanak Square
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2886 elnazashrafpour@gmail.com Iran University of Medical Sciences scientific Leila Amini
Rashid Yasemi Street, Vali-e-asr Ave
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 Amini.l@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 18-45 years At least 6 months have passed since the diagnosis of the disease Able to read and write in Farsi Living with a spouse at the time of the study Having sexual activity at least once in the last 4 weeks Monogamous husband Living in Tehran 18 years 45 years Female Suffering from another chronic disease other than Rheumatoid arthritis in research units Current pregnancy or breastfeeding and less than 6 months have passed since the last delivery According to the patient, the occurrence of a stressful incident 3 months before the intervention Suffering from major medical diseases affecting sexual relations (Diabetes, history of psychiatric disorders such as severe Depression, Psychosis, Bipolar disorder, substance abuse) according to the patient' statement and the contents of his file Taking drugs affecting sexual performance Sexual disorders under treatment in women or husbands (desire phase disorder, arousal phase disorder, orgasm disorder, sexual pain disorders) M05 Rheumatoid arthritis with rheumatoid factor Rehabilitation Rehabilitation Intervention group: First, the participants will complete questionnaires including demographic characteristic, clinical status of the disease, FSFI (Female Sexual Function Index) and AIMS2-SF (health status questionnaire). Also before the study, the disease activity of both groups will be measured using the DAS-28 tool by a rheumatologist. Then participants will receive a notebook to writing their feelings freely. In this study, the researcher will give complete oral explanations about the intervention implementation to participants in intervention group. Also, a written guide of the intervention implementation method will be given to them. The intervention group participants will express their feelings freely and voluntarily at home and preferably in a private room, once a day and 4 times a week for 4 weeks. Free writing of emotions will be regardless of spelling and compositional points. During the study period, the writing process of the patients will be followed up by the researcher at the end of each week via phone call. After the completion of the intervention, the study questionnaire will be sent via WhatSapp and email and participants will completed them again. Control group: First, the participants will complete questionnaires of demographic information and clinical status of the disease, FSFI (Female Sexual Function Index) and AIMS2-SF (health status questionnaire) before studying the disease activity of both group using the DAS-28 will be measured. The control group will receive only routine care after the pre-test. Disease activity. Timepoint: In each of the two test and control groups before the start of the study and 8 weeks after the intervention. Method of measurement: In both groups, it will be measured by a rheumatology specialist using the 28-DAS tool. Health status. Timepoint: The measurement of this variable will be done before the start of the study, immediately and 8 weeks after the end of the intervention. Method of measurement: Completing the health status questionnaire (AIMS2-SF) by the participants. Sexual function. Timepoint: The measurement of this variable in all 6 areas will be done before the start of the study, immediately and 8 weeks after the end of the intervention. Method of measurement: Completion of the Female Sexual Function Index (FSFI) questionnaire by the participants. Iran University of Medical Sciences Approved 2022-06-20 Research Ethics Committees of Iran University of Medical Sciences Iran Nursing and Midwifery School, Rashid Yasemi Ave., Vali-e-Asr Ave., Tehran Tehran Tehran Iran (Islamic Republic of)