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IRCT20231003059602N1 IRCT 2023-10-16 Kerman University of Medical Sciences To Investigate the Effectiveness of Supported Mirror Viewing Effect on Adjustment, Self-efficacy, and Self-disgust in Patients with Permanent Intestinal Ostomy Comparison of the Effectiveness of Supported Mirror Viewing Effect on Adjustment, Self-efficacy and Self-disgust with Routine Care in Patients with Permanent Intestinal Ostomy 2023-10-07 anticipated 100 Complete https://irct.ir/trial/72940 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Due to the availability of the ostomy patients' information list in the ostomy center, the simple randomization method is used in this study. First, a person who is not involved in the study prepares a list of patients with permanent ostomy. After checking the inclusion and exclusion criteria, she/he determines the number of eligible patients. Then, she/he writes the patient's admission number, which is a 7-digit code, on a non-transparent paper and pours it into a container. Then another person takes the cards out of the box one by one. The codes with odd numbers from the right side will be assigned to the intervention group and the others will be in the control group. More than 50 people are selected in each group so that if the patient does not want to participate or is excluded from the study, the next person will be replaced. In this study, there is no possibility of blinding the patients and the researcher. N/A Colorectal Cancer. Intervention 1: Intervention group: In this research, the intervention of supported mirror-viewing is performed by the main investigator as a 60-minute face-to-face session in a private place for 50 patients who have the possibility to attend the ostomy center, and the same session is conducted with the presence of the researcher at the patient's home for those who are unable to attend to the center. The educational content of the session is given to the patients in the form of a brochure on the day of the training for practice at home. Intervention 2: Control group: 50 people who complete the questionnaires at all three specified times are included in the control group, which will receive routine care and training provided by the ostomy nurse. If there will be a positive effect of training on outcome measures, the intervention will be conducted for the control group too. 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 in this regard.
public Omsalimeh Roudi Rashtabadi
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5201 fatroody@yahoo.com Kerman University of Medical Sciences scientific Omsalimeh Roudi Rashtabadi
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5201 fatroody@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age 18 years and older Having at least one permanent intestinal, sigmoid, or ileum ostomy due to colorectal cancer, etc. for at least three months Receive routine training from the ostomy specialist nurse in the ostomy clinic Willingness to look at the ostomy area and their body in the mirror with the help of the nurse 18 years no limit Both Having a temporary ostomy K94.0 Colostomy complications Rehabilitation Rehabilitation Intervention group: In this research, the intervention of supported mirror-viewing is performed by the main investigator as a 60-minute face-to-face session in a private place for 50 patients who have the possibility to attend the ostomy center, and the same session is conducted with the presence of the researcher at the patient's home for those who are unable to attend to the center. The educational content of the session is given to the patients in the form of a brochure on the day of the training for practice at home. Control group: 50 people who complete the questionnaires at all three specified times are included in the control group, which will receive routine care and training provided by the ostomy nurse. If there will be a positive effect of training on outcome measures, the intervention will be conducted for the control group too. The score of Jin et al. Colostomy Self-disgust Questionnaire. Timepoint: At the point of recruitment day, immediately after the intervention and three months later. Method of measurement: Jin et al. Colostomy Self-disgust Questionnaire. The score of Bekkers et al. Stoma Self-efficacy Questionnaire. Timepoint: At the point of recruitment day, immeditely after the intervention and three months later. Method of measurement: Bekkers et al. Stoma Self-efficacy Questionnaire. The score of Simmons et al. Ostomy Adjustment Questionnaire. Timepoint: At the point of recruitment day, immediately after the intervention and three months later. Method of measurement: Simmons et al. Ostomy Adjustment Questionnaire. Kerman University of Medical Sciences Approved 2023-09-27 Ethics committee of Kerman University of Medical Sciences No. 2, Ibn Sina Street, Deputy of research and technology Bldg. Kerman Kerman Iran (Islamic Republic of)