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IRCT20181030041501N1 IRCT 2020-05-08 Gorgan University of Medical Sciences The effect of nursing counseling on the anxiety level of elderly before endoscopy The effect of nursing counseling on the anxiety level of elderly patients undergoing upper gastrointestinal endoscopy 2020-04-18 anticipated 198 Complete https://irct.ir/trial/34971 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization: Patients will be randomly and equally (n=99) allocated to two intervention and control groups by a nurse, working in the inpatient ward, who has been trained in the random allocation of patients. Random allocation will be done as follows; first, we will consider two AB and BA combinations designated with the code names 1 and 2, respectively by throwing a homogeneous hexagon. If the odd number occurs, we will write down combination 1 (AB) and If the even number occurs, we will write down combination 2 (BA). This step will be repeated 99 times to create a random sequence of twin blocks. Then we randomly assign the patients to the members of this sequence (A and B). For example, the sequence of random blocks can be as follows: BABAABABABBA… Afterwards, by throwing a flawless coin, the patients assigned to the letter A will fall into the intervention group and the patients assigned to the letter B will fall into the control group. N/A The anxiety of elderly patients undergoing upper gastrointestinal endoscopy. Intervention 1: Intervention group: The patients in the intervention group will be received 30 minutes face to face educational counseling on the night before endoscopy. The educational counseling will be done based on the content of the booklet which produced by researchers and then the booklet is given to the patient. Intervention 2: Control group: The patients in the control group will receive the pre-endoscopic preparations and routine care. Yes - There is a plan to make this available What will be shared: All data will be shared after identifying people. When: Six months after publishing, the results of the data file will be presented. To whom: Data will be available to researchers working in academic institutions. Conditions: Meta analysis on data are allowed. Where to obtain: Please contact the person responsible for the study. How to obtain: Access to data through e-mail after obtaining permission from researchers is possible. Comments: To receive information, please email both the following addresses: kolagari_gorgan@yahoo.com; dr.kolagari@goums.ac.ir
public Sohrab Kor
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
Gorgan Iran (Islamic Republic of) 4917136536 +98 17 3217 5338 Nurse.kor@gmail.com Gorgan University of Medical Sciences scientific Shohreh Kolagari
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
Gorgan Iran (Islamic Republic of) 4917136536 +98 17 3245 6900 dr.kolagari@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Age over 60 years old Upper gastrointestinal endoscopy is prescribed at least one day in advance No previous endoscopic history Having the ability to establish verbal communication Not taking corticosteroid drugs Willingness to participate in the study 60 years 80 years Both Using hypnotic or sedative drugs before endoscopy Addiction Known case of psychiatric disease Having any lesion or ulcer in the mouth F06.4 Anxiety disorder due to known physiological condition Other Other Intervention group: The patients in the intervention group will be received 30 minutes face to face educational counseling on the night before endoscopy. The educational counseling will be done based on the content of the booklet which produced by researchers and then the booklet is given to the patient. Control group: The patients in the control group will receive the pre-endoscopic preparations and routine care. Level of anxiety. Timepoint: Before intervention and a day after intervention (before endoscopy). Method of measurement: Spielberger Anxiety Inventory. Level of salivary cortisol. Timepoint: Before intervention and a day after intervention (before endoscopy). Method of measurement: Saliva cortisol measurement kits, made by Diametra in Italy using ELISA method. Blood pressure. Timepoint: Before intervention and a day after intervention (before endoscopy). Method of measurement: The Sazgan Gostar portable monitoring system, Vista Model, made in Iran. Heart rate. Timepoint: Before intervention and a day after intervention (before endoscopy). Method of measurement: The Sazgan Gostar portable monitoring system, Vista Model, made in Iran. Respiratory rate. Timepoint: Before intervention and a day after intervention (before endoscopy). Method of measurement: The Sazgan Gostar portable monitoring system, Vista Model, made in Iran. Arterial blood saturation percentage. Timepoint: Before intervention and a day after intervention (before endoscopy). Method of measurement: The Sazgan Gostar portable monitoring system, Vista Model, made in Iran. Gorgan University of Medical Sciences Approved 2018-12-31 Ethics Committee of Golestan University of Medical Sciences Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan, Iran Gorgan Golestan Iran (Islamic Republic of)