The effect of virtual counseling and educational booklets on self-efficacy and anxiety of mothers with premature babies discharged from the neonatal intensive care unit
Comparison of the effect of virtual counseling and educational booklet on self-efficacy and anxiety of mothers with premature babies discharged from the neonatal intensive care unit
Design
In this study, two intervention groups including virtual counseling and educational booklets and a control group with a parallel design will participate.
Then, the samples will be randomly assigned to a group of 45 people for the intervention1 (receiving virtual counseling), a group of 45 for the intervention2 (receiving a training book) and a control group of 45 using 6 permutation blocks.
Settings and conduct
Mothers with premature babies discharged from the Neonatal Intensive Care Unit of Fatemieh Hospital in Hamedan who meet the inclusion criteria will be randomly allocated into three groups. The first group will receive virtual counseling, the second group will receive an educational booklet, and the third group will be the control group. Questionnaires will be completed before the intervention and 2 weeks later.
Participants/Inclusion and exclusion criteria
A healthy single baby with a birth age of 32-36 weeks
Intervention groups
Virtual consulting group: counseling sessions will be held in 4 sessions of 20-30 minutes 2 times a week with an interval of 3 days online.
Educational booklet group: In this group, after completing the questionnaires at the time of discharge, the educational booklet for post-discharge care of premature babies is given to the mothers, and for 2 weeks after completing the first questionnaire, the self-efficacy and anxiety questionnaires are repeated by the people of this group. The group will be completed.
Control group: In this group, the questionnaires will be completed electronically at the time of discharge and 2 weeks after that.
Main outcome variables
self-efficacy and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221217056842N2
Registration date:2023-12-03, 1402/09/12
Registration timing:registered_while_recruiting
Last update:2023-12-03, 1402/09/12
Update count:0
Registration date
2023-12-03, 1402/09/12
Registrant information
Name
Mansoureh Refaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
mansourehrefaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual counseling and educational booklets on self-efficacy and anxiety of mothers with premature babies discharged from the neonatal intensive care unit
Public title
The effect of virtual counseling and educational booklet on self-efficacy and anxiety of mothers with premature babies discharged from hospital
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
preterm birth between 32 and 36 week
singleton pregnancy
Ability to read and write in persian
Speaking in Persian
Ability to use online software
Internet access
Living with spouse
Exclusion criteria:
Abnormalities in the baby
Participation in training courses related to the topic of the research
Medical illnesses and drug use
History of any mental disorder
The occurrence of unfortunate and stressful events in the last 6 months (death of relatives, divorce, serious accidents, etc.)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random allocation will be determined by one of the researchers based on the permutation blocking method in three groups A, B and C using RAS( Random allocation software) software. The determined sequence will be written from beginning to end and placed in the sealed envelopes. Then, each envelope is assigned a number corresponding to the number of samples, from 1 to 135. Then the numbered envelopes are given to another researcher who is not aware of the random allocation process. Then the samples are placed in the control, virtual counseling and educational booklet groups in the order of arrival and in the order of the number of envelopes. After collecting the data, the data is entered into the software based on the number and group A, B and C. Thus the statistical analyst will not be aware of the type of assigned group.
Blinding (investigator's opinion)
Single blinded
Blinding description
After collecting the data, the data is entered into the software based on the number and group A, B and C and thus the statistical analyst will not be aware of the type of assigned group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Hamadan University Of Medical Sciences
Intervention group: For the first intervention group (virtual counseling), the time and application needed to hold virtual counseling sessions will be informed by phone. Individual counseling sessions will be held in 4 sessions of 20-30 minutes, 2 times a week with an interval of 3 days, online in the MEET application. The first counseling session will be held in the first three days after discharge (as agreed with the participant).
Category
Lifestyle
2
Description
Intervention group: In the second intervention group, after completing the questionnaires at the time of discharge, the mothers will be given a educational booklet. Self-efficacy and anxiety questionnaires will be completed again 2 weeks later by the people of this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Mansoureh Refaei
Street address
Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mansourehrefaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3131 4058
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Mansoureh Refaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0439
Email
mansourehrefaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mansoureh Refaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0439
Email
mansourehrefaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mansoureh Refaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0439
Email
mansourehrefaei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available