Effect of intra-rectal midazolam administration before urodynamic study on pain, stress and cooperation of patient during test in women

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210122050105N1

Enrollment

Registered

2021-01-25

Start date

2021-02-03

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of the sedative effect of midazolam in reducing pain and stress and increasing patient cooperation during urodynamic testing.

Interventions

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 ad

Eligibility

Sex/Gender

Female

Age

20 Years to 75 Years

Inclusion criteria

Inclusion criteria: Women between the ages of 20 to 75 Having urinary disorders Candidates for urodynamic testing

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 ar	—

Measure

Time frame

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 ar

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarjes Saberi

Esfahan University of Medical Sciences

narjessaberi@med.mui.ac.ir+98 31 3222 2127

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026