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IRCT20240327061372N1 IRCT 2024-05-24 Mashhad University of Medical Sciences A mobile application for patients with anal fistula Designing, developing and evaluating a mobile application to homecare after anal fistula surgical procedure 2024-08-05 anticipated 40 Complete https://irct.ir/trial/76169 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, people are randomly divided into two groups of intervention and control using quadruple blocks, Blinding description: This study was conducted using one-way blinding method. In order to reduce the amount of errors in the study so that the researcher or the group of researchers do not cause errors in the study unknowingly, the researchers anonymize the participants' information by using unidentifiable codes and deleting information. they did In this statistical analysis study, the group of patients will be identified with codes A and B. N/A An anal fistula is an abnormal tunnel under the skin that connects the anal canal in the colon to the skin of the buttocks. Most anal fistulas form in reaction to an anal gland that has developed a pus-filled infection (abscess).. Intervention 1: Intervention group: Patients who install the designed software when they receive the clinical letter and are interested in participating in the study, in this group, they are trained to complete the basic questionnaire, how to work with patients, and the informed consent form. . they receive. During the study, he was in contact with the patients through the application. who is placed in the Akhla group, must complete the patient history list every day for the first seven days, which includes complications such as fever, infectious symptoms, pain, etc., and if the patient needs a photo of the desired location. Wounds or submissions. In addition, the patient should read all the instructions of the program. After this period of time, he is required to complete the list once a week for three months. These patients will be monitored for up to one week for long-term side effects and short-term up to three months to check the quality of life of the patients. At the end of the third week and at the end of the third month, the satisfaction of the application will be evaluated in the application.The Persian version of the SUS questionnaire will be used to check the satisfaction of the system usability scale. Intervention 2: Control group: The control group will receive the usual recommendations at discharge. In the control group, if the patient returns to the clinic for a routine visit after surgery, the checklist and questions related to returning to daily activities and sexual activities will be completed in the clinic. Otherwise, they will be asked over the phone. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr Seyyed Mohammad Tabatabaei
Vakil abal Blvd.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3840 2972 moh.taba@gmail.com Mashhad University of Medical Sciences scientific Dr Abbas Abdollahi
Ahmad abad Blvd.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3840 2972 abdollahia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Patients with anal fistula who undergo surgical treatment at Ghaem hospital in Mashhad Patients must have a smartphone 18 years no limit Both Anal fistula following Crohn's disease Anal fistula following Colorectal cancer One of the family members is a member of the treatment staff Lack of access to a smartphone Unwillingness to cooperate and use the application K60.3 Anal fistula Other Other Intervention group: Patients who install the designed software when they receive the clinical letter and are interested in participating in the study, in this group, they are trained to complete the basic questionnaire, how to work with patients, and the informed consent form. . they receive. During the study, he was in contact with the patients through the application. who is placed in the Akhla group, must complete the patient history list every day for the first seven days, which includes complications such as fever, infectious symptoms, pain, etc., and if the patient needs a photo of the desired location. Wounds or submissions. In addition, the patient should read all the instructions of the program. After this period of time, he is required to complete the list once a week for three months. These patients will be monitored for up to one week for long-term side effects and short-term up to three months to check the quality of life of the patients. At the end of the third week and at the end of the third month, the satisfaction of the application will be evaluated in the application.The Persian version of the SUS questionnaire will be used to check the satisfaction of the system usability scale. Control group: The control group will receive the usual recommendations at discharge. In the control group, if the patient returns to the clinic for a routine visit after surgery, the checklist and questions related to returning to daily activities and sexual activities will be completed in the clinic. Otherwise, they will be asked over the phone. Time to wound healing. Timepoint: To wound healing, our team will in touch with patients every day through application. The patient who is in the intervention group is required to complete the history checklist every day for the first seven days, after this period, the patient is required to complete the checklist once a week for three months. Method of measurement: based on wound assessment by physician or wound image. Infectious complication. Timepoint: to third months after surgery, we are in touch with patients through application, continuously. so, any complications will be diagnosed as soon as possible. The patient who is in the intervention group is required to complete the history checklist every day for the first seven days, after this period, the patient is required to complete the checklist once a week for three months. Method of measurement: based on wound assessment by physician or wound image. Quality of life in anal fistula patients. Timepoint: Three months after surgery. Method of measurement: (Based on QoLAF questionnaire). Patient satisfaction with the treatment process in intervention group. Timepoint: At the end of the third week and at the end of the third month. Method of measurement: Based on SUS questionnaire. Time to daily activities. Timepoint: To third months after surgery, we are in touch with patients through application, continuously. The patient who is in the intervention group is required to complete the history checklist every day for the first seven days, after this period, the patient is required to complete the checklist once a week for three months. Method of measurement: Based on the patient's statement. Mashhad University of Medical Sciences Approved 2024-03-11 Research Ethics Committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad Ahmad abad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)