Determining The effect of developmental care education using Teach-back method on perceived stress and self- esteem of mothers with hospitalized premature newborn
Design
Field trial with control group, with parallel, randomized groups, 70 patients
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, complete the demographic characteristics checklist, the Perceived Stress Scale of Cohen et al and Rosenberg Self-Esteem Scale. In the intervention group, mothers individually, during the first 10 days of their newborns' stay in the neonatal intensive care unit, during 4 sessions lasting 45 to 60 minutes based on the same study, are exposed to developmental care education using Teach- back method will be done by the researcher.
No training will be given to the control group. immediately after completing the training, complete the Perceived Stress Scale of Cohen et al and Rosenberg Self-Esteem Scale. The place of the training is a room in the neonatal intensive care unit of Imam Sajjad Hospital (AS), in order to preserve the privacy of mothers.
Participants/Inclusion and exclusion criteria
Admission requirements: Willingness and informed consent to participate in the study, mothers with hospitalized premature newborn. Conditions of non-entry: Previous participation in studies similar to the current research.
Intervention groups
Intervention group: In this group, mothers individually, during the first 10 days of their newborns' stay in the neonatal intensive care unit, during 4 sessions lasting 45 to 60 minutes based on the same study, are exposed to developmental care education using Teach- back method will be done by the researcher. Control group: non-intervention: this training group will not be given.
Main outcome variables
Perceived stress and self- esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230712058758N1
Registration date:2023-10-07, 1402/07/15
Registration timing:registered_while_recruiting
Last update:2023-10-07, 1402/07/15
Update count:0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Zeinab Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 7253 1080
Email address
zaynabmokhtari792@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of developmental care education using Teach-back method on perceived stress and self- esteem of mothers with hospitalized premature newborn
Public title
The effect of developmental care education using Teach-back method on perceived stress and self- esteem of mothers with hospitalized premature newborn
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The experience of the first premature newborn admitted to the neonatal intensive care unit
A mother with a premature newborn with a history of hospitalization in the neonatal intensive care unit
single newborn
Willingness and informed consent to participate in the study
Gestational age more than 25 and less than 35 weeks
Mothers with mild, moderate or severe perceived stress on the Cohen Perceived Stress Scale
Exclusion criteria:
Newborn weight less than 800 grams at birth
Newborns suffering from birth defects
Previous participation in studies similar to the current research
Having a history of depression or other psychiatric disorders in the mother
Working in medical science
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of blocks in such a way that blocks of size 2, 4 and 6 will be used. For example, in the case where the block size is 2, we will have two states AB and BA (A and B are the intervention and control groups). In order to create the sequence and concealment, the online software with the following address will be used and a special randomization code will be generated: Sealed Envelope Ltd. 2021. Create a blocked randomization list. [online] Available from: http://www.sealedenvelope.com/simple-randomizer/v1/lists [Accessed 16 July 2022]
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-08-30, 1402/06/08
Ethics committee reference number
IR.YUMS.REC.1402.093
Health conditions studied
1
Description of health condition studied
premature newborn
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Perceived stress
Timepoint
The level of perceived stress by mothers at the beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
The Perceived Stress Scale of Cohen et al
2
Description
Self- esteem
Timepoint
The level of self- esteem by mothers at the beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Rosenberg Self-Esteem Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, mothers individually, during the first 10 days of their newborns' stay in the neonatal intensive care unit, during 4 sessions lasting 45 to 60 minutes based on the same study, are exposed to developmental care education using Teach- back method will be done by the researcher. In this group, the teach-back method with the 5T model will be used. The 5T model is a standard and operational definition of teach-back method that includes 5 steps; triage, tools, take responsibility, tell me and try again. The triage, tool, and take responsibility steps focus on effective comprehension of information and the tell me and try again steps to assess whether the patient has received the information. The Take Responsibility and Tell Me steps are referred to as " Teach Back lead-in." The steps of the teach-back method will include such things; Step 1: The teacher will ensure that he has used simple language and explained the concepts or process to the care recipient. Medical words and terms will be avoided. Step 2: The teacher will ask the care recipient to repeat the content in his own language: How did he understand the concepts or process that the researcher explained? Step 3: The teacher will identify and correct the care recipient's misperception or incorrect performance. Step 4: The instructor will question the care recipient again about what was taught to ensure that the misunderstanding has been corrected. Step 5: The instructor will repeat steps 4 and 5 until he is convinced that the care recipient understands the concepts or has the ability to perform the procedure correctly and safely. In the teach-back method using the same study, after teaching new information, mothers will be asked to explain that information in their own language. Then the level of knowledge of mothers and the adequacy of their explanations will be determined. The mother will repeat the instructions in her own language. In this way, the researcher will be able to evaluate the mother's understanding of the information. If the mother does not repeat the information correctly, the training phase will be completed for that information and progress will be resumed for the new information. However, if there is a defect or error in it, the information will be corrected and repeated by the researcher, and the mother will be asked to express the information in her own language. After completing the cycle, the mother will be asked: "Do you have any other questions?" If possible, open questions will be asked and closed questions will be avoided.
Category
Lifestyle
2
Description
Control group: non-intervention: this training group will not be given.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Zeinab Mokhtari
Street address
Imam Sajjad Hospital, Next to Hotel Azadi, Yasuj, Kohgiloyeh and Boyerahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 0166
Email
zaynabmokhtari792@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Zeinab Mokhtari
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alley 26, Haft Tir Blvd., Nurabad, Fars, Islamic Republic of Iran
City
Nurabad
Province
Fars
Postal code
7351794374
Phone
+98 71 7253 1080
Email
zaynabmokhtari792@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zeinab Mokhtari
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alley 26, Haft Tir Blvd., Nurabad, Fars, Islamic Republic of Iran
City
Nurabad
Province
Fars
Postal code
7351794374
Phone
+98 71 7253 1080
Email
zaynabmokhtari792@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zeinab Mokhtari
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alley 26, Haft Tir Blvd., Nurabad, Fars, Islamic Republic of Iran
City
Nurabad
Province
Fars
Postal code
7351794374
Phone
+98 71 7253 1080
Email
zaynabmokhtari792@gmail.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