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IRCT20150905023897N6 IRCT 2023-05-16 Tarbiat Modares University Investigating the effect of midwifery-designed training on perceived anxiety and pain intensity from hysterosalpingography in infertile women Investigating the effect of midwifery-designed training on perceived anxiety and pain intensity from hysterosalpingography in infertile women 2023-05-20 anticipated 86 Complete https://irct.ir/trial/68926 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Other design features: In this research, it should be measured the level of target group's knowledge about hysterosalpingography. To achieve this, a questionnaire should be prepare by researcher whose validity and reliability are also measured, Randomization description: In order to perform randomization, the researcher put 4 balls, including 2 white balls: intervention and control, and 2 black balls: even day and odd day, which he named in this way and put them in a container and asked someone to pick up two different colors. This is the way that those balls were selected: even day and intervention, odd day and control. In this way, people who visit on even days are in the intervention group, and people who visit on odd days are in the control group, Blinding description: After admission, people are randomly assigned to each of the intervention and control groups. None of them were informed about their group and they just trained about the stages what should they do. 2 Female infertility. Intervention 1: Control group: Control group: After accepting people according to the entry criteria, and obtaining informed consent, people are randomly assigned to the control and intervention groups. The control group does not receive any educational or counseling intervention and only the center's routine admission is done for them. The other mentioned cases are the same in both groups. including questionnaires and timings necessary to measure the variables. Intervention 2: Intervention group: After accepting people according to the entry criteria, and obtaining informed consent, people are randomly assigned to control and intervention groups. People in the intervention group receive educational items and counseling (educational intervention) before performing hysterosalpingography. Yes - There is a plan to make this available What will be shared: Information on the main outcome of the study When: 2023 To whom: Academic researchers Conditions: Use for additional research in the future Where to obtain: Email Addressing Responsible for study How to obtain: Submit a request to study and follow up Comments:
public Shahideh Jahanian Sadatmahalleh
Jalal E Al Ahmad
Tehran Iran (Islamic Republic of) 141173116 +98 21 8288 4826 shahideh.jahanian@modares.ac.ir Tarbiat Modares University scientific Shahideh Jahanian Sadatmahalleh
Jalal E Al Ahmad
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 2230 6480 shahideh.jahanian@modares.ac.ir Tarbaiat Modares University Iran (Islamic Republic of) Voluntary infertile women Age 20-49 years Iranian nationality Ability to speak Persian Literacy Not suffering from known anxiety disorders or other mental illnesses affecting anxiety under treatment No history of HSG People who are inclined to participate in the study. 20 years 49 years Female Patient withdrawal from the study Failure to complete the HSG process for any reason Presence of tubal or uterine lesions, such as cervical stenosis, which cause "severe pain" in the HSG process N97.1 Female infertility of tubal origin Behavior Behavior Control group: Control group: After accepting people according to the entry criteria, and obtaining informed consent, people are randomly assigned to the control and intervention groups. The control group does not receive any educational or counseling intervention and only the center's routine admission is done for them. The other mentioned cases are the same in both groups. including questionnaires and timings necessary to measure the variables. Intervention group: After accepting people according to the entry criteria, and obtaining informed consent, people are randomly assigned to control and intervention groups. People in the intervention group receive educational items and counseling (educational intervention) before performing hysterosalpingography. The patient's heart rate. Timepoint: Heart rate measurement at the beginning of the study (before the intervention), half an hour before the intervention, immediately and half an hour after the intervention. Method of measurement: Pulse meter. The patient's blood pressure. Timepoint: Blood pressure measurement at the beginning of the study (before the intervention), half an hour before the intervention, immediately and half an hour after the intervention. Method of measurement: Sphygmomanometer. Patients' awareness of hysterosalpingography. Timepoint: Measuring the patient's knowledge about hysterosalpingography at the beginning of the study (before the intervention), half an hour before the intervention, immediately and half an hour after the intervention. Method of measurement: Hysterosalpingography awareness questionnaire (made by a researcher). Patient anxiety. Timepoint: Measuring the patient's anxiety at the beginning of the study (before the intervention), half an hour before the intervention, immediately and half an hour after the intervention. Method of measurement: State Trait Anxiety Inventory (STAI). Perceived pain from the hysterosalpingography procedure. Timepoint: Measurement of perceived pain in the initial study (before the intervention), half an hour before the intervention, treatment and half an hour after the intervention. Method of measurement: Visual analog scale. Tarbiat Modares University Approved 2022-10-03 Ethics committee of Tarbiat Modares University Tarbiat Modares University, Nasr bridg, Ale ahmad high way,Tehran Tehran Tehran Iran (Islamic Republic of)