Comparison of the Effect of Two Educational Methods Booklet and Role-Playing on Mother’s Knowledge and Perception of Self-Efficacy Regarding Infant Pain Management
Determining and comparing knowledge and Perception of Mothers' Self-Efficacy about infant Pain Management in the Control, Booklet and Role playing Groups before and after the Intervention.
Design
Quasi-experimental Study with control group, with parallel groups, on 75 infants
Settings and conduct
In the intervention group, an educational booklet containing contents in the field of management in the infant is given to the mother. Then, in two one and a half hour sessions, the researcher discusses the contents of the booklet face to face with the mother. In the intervention group, two educational contents will be taught to the mother through role-playing in two sessions of one and a half hours. For this purpose, individual sessions will be held in coordination with the mother and according to her wishes in the baby's bed. In the control group, they will receive routine training. These exercises are oral and include generalities about calming the baby, such as non-nutritious cuddling and sucking with the mother's finger.
Participants/Inclusion and exclusion criteria
Their babies are full-time and are fed under the mother's breast.The mother should live next to the baby; Mothers with a history of pain management education.Changes in the baby's clinical condition
Intervention groups
Three intervention groups. One Group will receive a pain management training booklet in addition to routine care. In addition to routine care, the second group receives pain management training through role-playing, and the third group receives only routine training.
Main outcome variables
Knowledge; Perception of Mothers' Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100823004617N17
Registration date:2021-01-27, 1399/11/08
Registration timing:registered_while_recruiting
Last update:2021-01-27, 1399/11/08
Update count:0
Registration date
2021-01-27, 1399/11/08
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Two Educational Methods Booklet and Role-Playing on Mother’s Knowledge and Perception of Self-Efficacy Regarding Infant Pain Management
Public title
Comparison of the Effect of Two Educational Methods Booklet and Role-Playing on Mother’s Knowledge and Perception of Self-Efficacy Regarding Infant Pain Management
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Their babies are full-term and are fed under the mother's breast
48 hours after the baby was admitted to the ward.
The mother resides with the baby.
The mother is physically and mentally healthy
The mother is literate.
The baby has no history of hospitalization.
Exclusion criteria:
The mother is an employee of the health care system
Mothers with a history of pain management education.
Discharge or death of the baby or transfer of the baby to other medical centers
Withdrawal from continuing to participate in the study
Changes in the baby's clinical condition and malaise
Age
From 14 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences.,Attar Neyshabouri St., Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-11-02, 1399/08/12
Ethics committee reference number
IR.TBZMED.REC.1399.771
Health conditions studied
1
Description of health condition studied
Infants Pain Management
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Mothers' knowledge about Infant Pain Management
Timepoint
Before the Intervention and 72 Hours after The Intervention
Method of measurement
Using a Researcher-Made Questionnaire
2
Description
Understanding Mothers' Self-Efficacy in Infant Pain Management
Timepoint
Before the Intervention and 72 Hours after The Intervention
Method of measurement
Using a Researcher-Made Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The control group will receive routine ward training. These exercises are oral and include generalizations about calming the baby, such as non-nutritious cuddling and sucking with the mother's finger. These trainings are usually given to the mother before performing a painful procedure such as blood sampling, venipuncture, etc., or the baby's pain following bloating.
Category
Treatment - Other
2
Description
In intervention second group , in addition to routine care, an educational booklet will be given to mothers. This booklet contains content on the definition of pain, pain symptoms in infants, management methods in infants and in particular common non-pharmacological methods in pain management (skin-to-skin care, non-nutritious sucking, sucrose and breast milk) . After reading the content by the mother, the researcher will discuss the contents of the booklet face to face with the mother in two one and a half hour sessions in order to answer any questions or ambiguities in the content of the booklet. With the coordination of the mother and according to her desire, it will be formed in the baby's bed. In this method, to ensure the mother's learning, scenarios will be prepared by the researcher and mothers will be asked to explain how to control and manage pain in the baby. For example, the mother is asked to 'explain the correct amount and method of giving sucrose to a baby weighing 3 kg'. During the intervention, the mother's strengths and weaknesses are fed to her by the researcher.
Category
Treatment - Other
3
Description
In the third intervention group, in addition to routine care, the educational content will be taught to the mother through role-playing in two sessions of one and a half hours. For this purpose, individual sessions will be held in coordination with the mother and according to her wishes in the baby's bed. The image will be used to better understand theoretical issues such as pain symptoms in the baby. Common non-pharmacological methods of pain management, such as skin-to-skin care, non-nutritious sucking, oral sucrose, and practical breastfeeding, will be taught to the mother. For this purpose, depending on the circumstances, the mannequin or the baby (if the baby is asleep from the mannequin) will be used to educate the mother. To ensure the mother's learning, scenarios will be developed by the researcher and mothers will be asked to demonstrate how to control and manage pain in the baby using the methods described on the baby / mannequin. For example, the mother is asked to 'determine the amount of sucrose received for a baby weighing 3 kg and show the correct way to give sucrose to the baby'. During the intervention, the mother's strengths and weaknesses are fed to her by the researcher.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Dr. Mahnaz Jabraeili
Street address
Children's Hospital., Shesgelan Street., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
kodakanhospital@tbzmed.ac.ir
Web page address
https://childrenhospital.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
No. 2 Central Building, Research Deputy of Tabriz University of Medical Sciences., Golgasht Street., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 4280
Email
research-vice @tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shariati Street., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
jabraeilim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery.,Shariati Street.,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
jabraeilim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shariati Street., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
0098 41 3364658
Email
jabraeilim@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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