Determining the effect of the educational program designed by midwives on the level of anxiety and perceived pain intensity of performing
Design
Clinical trial with control and intervention group, single groups, single-blind, randomized, phase 2 on 86 patients, random number table was used for randomization.
Settings and conduct
This study is conducted on infertile women who are candidates for HSG, referring to the imaging department of Royan Research Institute. After admission, people are placed in intervention and control groups based on even and odd days. For blinding, none of the subjects were told which group they were in.
Participants/Inclusion and exclusion criteria
Entry requirements: Infertile women volunteer for Hysterosalpingography
Age range 20-49 years
Iranian nationality
Ability to speak Persian
Literacy for reading and writing
Not suffering from known anxiety disorders or other mental illnesses affecting anxiety under treatment
Failure to enter: History of (HSG)
Early diagnosis of tubal and uterine lesions that cause severe pain in a person.
Intervention groups
In the intervention group, after accepting and obtaining informed consent, the people of this group are offered a face-to-face training program where people can ask their questions to the trainer. People complete the relevant questionnaires after each stage.
In the control group, after accepting and providing an explanation about the research, people complete the questionnaires and tools with informed consent. And no educational intervention is done for them.
Main outcome variables
Reduction of anxiety and pain perceived by women undergoing (HSG).
Decrease heart rate and blood pressure of people
Increasing people's awareness of (HSG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150905023897N6
Registration date:2023-05-16, 1402/02/26
Registration timing:prospective
Last update:2023-05-16, 1402/02/26
Update count:0
Registration date
2023-05-16, 1402/02/26
Registrant information
Name
ِDr. Shahideh Jahanian Sadatmahalleh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4826
Email address
shahideh.jahanian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of midwifery-designed training on perceived anxiety and pain intensity from hysterosalpingography in infertile women
Public title
Investigating the effect of midwifery-designed training on perceived anxiety and pain intensity from hysterosalpingography in infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 20 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Single
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr bridg, Ale ahmad high way,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.MODARES.REC.1401.144
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.1
ICD-10 code description
Female infertility of tubal origin
Primary outcomes
1
Description
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
2
Description
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
3
Description
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)
4
Description
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)
5
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
ُShahideh Jahanian Sadatmahalleh
Street address
East Hafez St, North Bani Hashem St, Resalat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2000
Fax
+98 21 2230 6481
Email
info@royaninstitute.org
Web page address
https://www.royan.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Phone
+98 21 8800 6544
Fax
+98 21 8800 6544
Email
pres@modares.ac.ir
Web page address
https://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4826
Fax
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbaiat Modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Phone
+98 21 2230 6480
Fax
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbaiat Modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 2230 6480
Fax
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome of the study
When the data will become available and for how long
2023
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Use for additional research in the future
From where data/document is obtainable
Email Addressing Responsible for study
What processes are involved for a request to access data/document