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IRCT20220731055588N1 IRCT 2022-08-09 Shahid Beheshti University of Medical Sciences Design, Implementation and Evaluation of Preoperative Patient Self-Efficacy Training Program in Ostomy Care Design, Implementation and Evaluation of Preoperative Patient Self-Efficacy Training Program in Ostomy Care 2022-08-06 anticipated 80 Complete https://irct.ir/trial/65032 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation will be done using a coin toss by an independent researcher. To prepare the randomized list, a coin will be tossed 80 times. If the coin lands on A, it means the intervention group, and if it lands on B, it means the control group. The randomization results will be recorded in a list from 1 to 80 respectively. In order to hide the results from the researcher's view, according to the list, each of the results will be recorded on a sheet and will be placed in a sealed envelope. The list number corresponding to that result will be written on each envelope. After each sample enters the research, the envelopes from 1 to 80 will be opened and the placement of the patient in the intervention or control group will be determined. N/A Colostomy; Ileostomy; Colon Malignancies. Intervention 1: Intervention group: (Pre-surgery training In addition to usual training) The patients who are allocated in the intervention group will be invited to participate in an ostomy care training session within one week before surgery in the one of clinic visit sessions or during hospitalization. A training session for 45 minutes will be held in the hospital or clinic for each patient independently. The researcher along with a wound and ostomy nurse will lead the training session. The goals of the training session will include a) familiarizing the patient with the educational content at the level of cognitive perception and b) the ability to change the ostomy bag and take care of the skin around the ostomy at the level of imitation of the psychomotor domain. Educational content will be presented to patients by using lectures, practical simulation of ostomy bag replacement skills, presentation of educational booklets to patients and introduction of online pages in virtual social networks to learn more. Content will be presented in simple and understandable language for the patient. The educational booklet and online pages of social networks will be prepared by the researcher based on the educational content and with the final approval of the faculty members of Shahid Beheshti University of Medical Sciences. The online pages of social networks will contain uploaded texts, images and educational videos; The membership link will only be available to patients of the intervention group or one of their family members (if the patient wishes). The time of use of educational materials will be at the disposal of the patient, who can adjust it according to his needs. The ostomy bag replacement simulation tool will include one-piece and two-piece ostomy bag, ostomy size measurement template, scissors, marker, gloves, ostomy powder, ostomy paste, ostomy skin protection ring, ostomy belt, intestinal ostomy simulator. The patient will have Practical work on the simulator under the guidance of a wound and ostomy nurse to familiarize with how to change the ostomy bag and related tips to prevent skin complications related to ostomy. The patient's family and their caregivers will be allowed to attend the training session. Intervention 2: Control group: (Usual training) For the patients in the control group, there will be no training by the research team. These patients will be trained in the usual way, i.e. after surgery and before discharge. Yes - There is a plan to make this available What will be shared: All data collected from assessed variables can be shared after de-identification. When: As soon as the article is published, it can be shared. To whom: All researchers and interested parties are allowed to receive research data. Conditions: Sending a request via email is required to receive data by researchers and interested parties. Where to obtain: Sending a request via email is required to receive data by researchers and interested parties. email: m_ilkhani@yahoo.com How to obtain: Sending a request via email is required to receive data by researchers and interested parties. Comments:
public Mahnaz Ilkhani
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, No. 2660, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 m_ilkhani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mahnaz Ilkhani
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, No. 2660, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717433 +98 21 8865 5366 m_ilkhani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 to 65 years Lack of cognitive or mental impairment Ability to verbal communicate 18 years 65 years Both Performing emergency surgery Other Other Intervention group: (Pre-surgery training In addition to usual training) The patients who are allocated in the intervention group will be invited to participate in an ostomy care training session within one week before surgery in the one of clinic visit sessions or during hospitalization. A training session for 45 minutes will be held in the hospital or clinic for each patient independently. The researcher along with a wound and ostomy nurse will lead the training session. The goals of the training session will include a) familiarizing the patient with the educational content at the level of cognitive perception and b) the ability to change the ostomy bag and take care of the skin around the ostomy at the level of imitation of the psychomotor domain. Educational content will be presented to patients by using lectures, practical simulation of ostomy bag replacement skills, presentation of educational booklets to patients and introduction of online pages in virtual social networks to learn more. Content will be presented in simple and understandable language for the patient. The educational booklet and online pages of social networks will be prepared by the researcher based on the educational content and with the final approval of the faculty members of Shahid Beheshti University of Medical Sciences. The online pages of social networks will contain uploaded texts, images and educational videos; The membership link will only be available to patients of the intervention group or one of their family members (if the patient wishes). The time of use of educational materials will be at the disposal of the patient, who can adjust it according to his needs. The ostomy bag replacement simulation tool will include one-piece and two-piece ostomy bag, ostomy size measurement template, scissors, marker, gloves, ostomy powder, ostomy paste, ostomy skin protection ring, ostomy belt, intestinal ostomy simulator. The patient will have Practical work on the simulator under the guidance of a wound and ostomy nurse to familiarize with how to change the ostomy bag and related tips to prevent skin complications related to ostomy. The patient's family and their caregivers will be allowed to attend the training session. Control group: (Usual training) For the patients in the control group, there will be no training by the research team. These patients will be trained in the usual way, i.e. after surgery and before discharge. The ostomy self-efficacy: The Ostomy self-efficacy is equal to the score obtained by the patient in the ostomy self-efficacy questionnaire. The questionnaire has 22 items in a 5-item Likert scale. The questionnaire is in two dimensions includes ostomy care self-efficacy (13 items) and social self-efficacy (9 items). A higher score indicates higher self-efficacy. The lowest score that can be obtained in this tool is 22 and the highest score is 110. Timepoint: The stoma self-efficacy questionnaire will complete by patients before surgery and one month after surgery. Method of measurement: The stoma self-efficacy scale was designed and psychometrically evaluated by Beckers et al. (1996). The questionnaire has 22 items in two dimensions, including ostomy care self-efficacy (first 13 items) and social self-efficacy (next 9 items). Using a Likert scale, the answers are defined from not sure at all (score 1) to completely sure (score 5). A higher score indicates greater ostomy self-efficacy. The lowest score that can be obtained in this tool is 22 and the highest score is 110. Hospitalization time. Timepoint: One month after surgery. Method of measurement: Clinical records and patient interview. The number of readmissions. Timepoint: One month after surgery. Method of measurement: Clinical records and patient interview. The number of emergency visits. Timepoint: One month after surgery. Method of measurement: Clinical records and patient interview. Peristomal skin condition. Timepoint: One month after surgery. Method of measurement: DET ostomy skin tool. Shahid Beheshti University of Medical Sciences Approved 2022-06-21 Ethics Committee of Pharmacy, Nursing and Midwifery Faculties of Shahid Beheshti University of Medic School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, No. 2660, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)