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IRCT20210122050105N1 IRCT 2021-01-25 Esfahan University of Medical Sciences Effect of intra-rectal midazolam administration before urodynamic study on pain, stress and cooperation of patient during test in women Effect of intra-rectal midazolam administration before urodynamic study on pain, stress and cooperation of patient during test in women 2021-02-03 anticipated 80 Complete https://irct.ir/trial/53838 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients with inclusion criteria were randomly divided into two groups using random allocation software. It is an individual randomization unit. Randomization is done in a simple way. A list of random numbers created with computer statistical software is used. It is not possible to blind the technician, but Collectors of data related to the patient's pain and stress as well as data analysts are blind to the intervention. 4 Evaluation of the sedative effect of midazolam in reducing pain and stress and increasing patient cooperation during urodynamic testing. Intervention 1: Intervention group: In the case group (intervention), 10 minutes before the start of the test, 0.3 mg according to the patient's weight and with a maximum dose of 15 mg midazolam is administered rectally via a catheter.15 ml midazolam ampoule is used for this purpose. To do this, insert the catheter about 10 cm into the anus and after administering midazolam, remove the tube extension. Urodynamic testing is then performed on patients in a standard manner. Before the intervention and after the intervention, during the test, the patients' blood pressure, heart rate and arterial blood oxygen saturation percentage, and at the end of the test, the amount of pain and stress and the patient's cooperation are evaluated and recorded. Intervention 2: Control group: In the control group, urodynamic test is performed by the standard method without rectal administration of midazolam, before and during the test, patients' blood pressure, heart rate, and arterial blood oxygen saturation percentage and at the end of the test, the amount of pain and stress and patient cooperation are evaluated and recorded. 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 "No more information"
public Narjes Saberi
Isfahan University of Medical Sciences,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3222 2127 narjessaberi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Narjes Saberi
Isfahan University of Medical Sciences,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 narjessaberi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Women between the ages of 20 to 75 Having urinary disorders Candidates for urodynamic testing 20 years 75 years Female History of heart and respiratory diseases History of known psychiatric disorders History of taking sedatives or anti-anxiety drugs 1 month before the test History of spinal cord injury History of sensory bladder disorder Treatment - Drugs Treatment - Drugs Intervention group: In the case group (intervention), 10 minutes before the start of the test, 0.3 mg according to the patient's weight and with a maximum dose of 15 mg midazolam is administered rectally via a catheter.15 ml midazolam ampoule is used for this purpose. To do this, insert the catheter about 10 cm into the anus and after administering midazolam, remove the tube extension. Urodynamic testing is then performed on patients in a standard manner. Before the intervention and after the intervention, during the test, the patients' blood pressure, heart rate and arterial blood oxygen saturation percentage, and at the end of the test, the amount of pain and stress and the patient's cooperation are evaluated and recorded. Control group: In the control group, urodynamic test is performed by the standard method without rectal administration of midazolam, before and during the test, patients' blood pressure, heart rate, and arterial blood oxygen saturation percentage and at the end of the test, the amount of pain and stress and patient cooperation are evaluated and recorded. Evaluation of the effect of rectal administration of midazolam on the patient's pain during urodynamic test. Timepoint: after the test. Method of measurement: Pain measuring ruler that measures the patient's pain from 0 to 10 at the same time as the number and shape.(Visual Analogue Scale). Evaluation of the effect of rectal administration of midazolam on patient stress during urodynamic testing. Timepoint: after the test. Method of measurement: stress measuring ruler that measures the patient's stress from 0 to 5 at the same time as the number and shape.(Visual Analogue Scale). Evaluation of the effect of rectal administration of midazolam on patient cooperation during urodynamic testing. Timepoint: after the test. Method of measurement: This index is graded from 0 to 3 and will be recorded by the technician performing the test after completing the steps. The degree of cooperation is classified as follows: 0, indicates poor cooperation (non-cooperation, the patient disrupts the test and needs to repeat the test); 1, indicates sufficient cooperation (patient cooperation is not complete but there is no need to repeat the test); 2, indicates good cooperation (cooperation is appropriate for most of the test and the patient cooperates for a better test); 3, Excellent cooperation (cooperates fully with the technician and executes instructions at all times during the test). Evaluation of changes in the patient's blood pressure after rectal administration of midazolam before performing urodynamic test. Timepoint: At the beginning of the study (before the intervention). During the test (after the intervention). Method of measurement: Mercury sphygmomanometer. Evaluation of changes in patient heart rate after rectal administration of midazolam before urodynamic test. Timepoint: At the beginning of the study (before the intervention). During the test (after the intervention). Method of measurement: Pulse oximeter device. Investigation of changes in saturation percentage of arterial blood oxygen saturation of the patient after rectal administration of midazolam before performing urodynamic test. Timepoint: At the beginning of the study (before the intervention). During the test (after the intervention). Method of measurement: Pulse oximeter device. Esfahan University of Medical Sciences Approved 2021-01-03 Ethics committee of Isfahan University of Medical Sciences Ostandari Street, Khorshid Hospital, Urology Department Isfahan Isfehan Iran (Islamic Republic of)