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IRCT20231206060275N1 IRCT 2024-02-05 Gonabad University of Medical Sciences Comparing the effect of familiarizing older adult candidates on their anxiety. Comparing the effects of familiarizing surgical process through watching videos, and visiting the operating environment on anxiety of elderly candidates for cataract surgery. 2024-02-20 anticipated 81 Complete https://irct.ir/trial/74214 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients will randomly assign into three groups using the balanced blocking randomization method with three permutation blocks. To do this, the letters A, B, and C were consider for the two intervention and control groups, respectively. Possible modes in the permutation block method are six modes that include (ACB, CBA, CAB, BCA, BAC, and ABC). Each mode will write on a card and the cards will assign the number one to six. Then, a mode will select by rolling of a dice, one of the six possible modes will select. Based on the selected mode, patients will allocate into three groups. This process will continue until the sample size will complete, Blinding description: In this study, the outcome evaluator will be a person other than the main researcher who will not be aware of the study groups. The data and study groups will provide to the statistical analyst as codes. N/A anxiety. Intervention 1: For this group, the video related to the surgical procedure and operating room environment and the processes before, during and after the operation will be shown. The duration of this film is 10 minutes, which is shown individually for each patient on the day before the operation in the ophthalmologist's office. Intervention 2: Intervention group: The day before the operation, the patient will visit the operating environment and the patient's inpatient department. While familiarizing the patient with the personnel and the environment, the cataract surgery process will be explained. Intervention 3: Control group: The control group will go through the usual procedure of surgery and no intervention will be done. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals when publishing an article. When: Data access begins 3 months after publication of results To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Any data analysis will be allowed with the consent of the main researcher. Where to obtain: The main researcher (correspondence) How to obtain: It will be sent in the shortest time with an official request and through an email. Comments:
public Akram Nami
Saadi ave. Parastar blvd, Bohlool Hospital
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 Eoc@gmu.ac.ir Gonabad University of Medical Sciences scientific Akram Nami
Saadi ave. Parastar blvd, Bohlool Hospital
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 Eoc@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Not having a history of mental, cardiovascular, and respiratory disorders Age 60 years and older No hearing impairment No use of sedatives and beta-blockers Not having a previous history of cataract surgery Not having severe anxiety 60 years no limit Both Unwillingness to continue participating The occurrence of events that affect the patient's anxiety F06.4 Anxiety disorder due to known physiological condition Prevention Prevention N/A For this group, the video related to the surgical procedure and operating room environment and the processes before, during and after the operation will be shown. The duration of this film is 10 minutes, which is shown individually for each patient on the day before the operation in the ophthalmologist's office. Intervention group: The day before the operation, the patient will visit the operating environment and the patient's inpatient department. While familiarizing the patient with the personnel and the environment, the cataract surgery process will be explained. Control group: The control group will go through the usual procedure of surgery and no intervention will be done. Anxiety score in the Spiel berger questionnaire. Timepoint: At the beginning of the study, before the intervention, after the intervention and half an hour before the surgery. Method of measurement: the Spielberger questionnaire. Breathing rate, heart rate, blood pressure. Timepoint: At the beginning of the study and before the intervention, after the intervention, half an hour before the operation. Method of measurement: Counting breathing and heart rate in one minute, mercury sphygmomanometer. Gonabad University of Medical Sciences Approved 2023-11-14 Ethics committee of Gonabad University of Medical Sciences saadi Av , Parastar Blvd, ems department Gonabad Razavi Khorasan Iran (Islamic Republic of)