The effect of kangaroo mother care by role-playing method on resilience and breastfeeding self-efficacy in mothers of premature neonates, Fatemieh hospitalized in neonatal intensive care unit, Hamadan, 2021
The effect of kangaroo mother care by role-playing method on resilience and breastfeeding self-efficacy
Design
Clinical trial with one control group and one intervention group , one-blind, randomized
Settings and conduct
Neonatal Intensive Care Units, Fatemieh Health Services Center, Hamedan
the person who will analyze the data will be blinded
Participants/Inclusion and exclusion criteria
All mothers of newborns admitted to the intensive care unit of Fatemieh Hospital
Intervention groups
To perform the intervention, the mothers of the experimental group, each mother individually attends two sessions of 30 minutes in the conference room and is taught how to perform cuddle care using the baby model. First, the researcher talks to the mother and answers their questions about how to care for, hug, and caress the baby. It then helps them wear a special blouse designed according to the kangaroo care standard and protocol. These blouses are loose, have sleeves, short buttons with a distance from the front of the dress that can be easily opened and closed. The mother then sits in a comfortable chair in a sitting or half-sitting position that feels comfortable. The baby modeling researcher, who only has a hat and diaper, places it vertically between the mother's two breasts. Closes the bottom buttons of the mother blouse. This model will be placed completely in the mother's breast and in the fabric fence, reducing the possibility of falls and hypothermia. The researcher then stands next to the mother and asks her to try to make eye contact with the model while smiling and caressing and talking to her. Mothers in the intervention group, after training in embrace care by role-playing method, perform embrace care with the supervision. Mothers in the control group will receive a routine kangaroo mother care training (pamphlet).
Main outcome variables
Resilience and self-efficacy of breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044082N4
Registration date:2021-04-20, 1400/01/31
Registration timing:prospective
Last update:2021-04-20, 1400/01/31
Update count:0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kangaroo mother care by role-playing method on resilience and breastfeeding self-efficacy in mothers of premature neonates, Fatemieh hospitalized in neonatal intensive care unit, Hamadan, 2021
Public title
The effect of kangaroo mother care by role-playing method on resilience and breastfeeding self-efficacy in mothers of premature neonates, Fatemieh hospitalized in neonatal intensive care unit, Hamadan, 202
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants weighing 1,800 grams or less
Have a minimum APGAR score of 5 minutes for births 7 and above
Do not undergo photo therapy
The baby is 30 weeks old
older Single twin babies
The baby has not had surgery
the infant should have the conditions to leave the incubator and warmer according to the opinion of a specialist doctor
The baby has the ability to suck on the mother's breast
Non-use of psychiatric drugs and tobacco by the mother
Mothers age 18 years and older
Mothers have the ability to read and write
Second childbirth onwards
The first infant admitted to the intensive care unit
Mothers' desire to participate in the study
Healthy babies without severe physical disorders
Exclusion criteria:
psychiatric problems in mothers (depression, bipolar, etc.)
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, two neonatal intensive care units are available to researchers. For random allocation of samples in the control and intervention groups, 6 types of 4 blocks will be used as random block allocation by alternative method. Thus, the letter A will be considered for the intervention group and the letter B for the control group. On the pieces of paper, write the following blocks and put them in an envelope and we will randomly place them. Next, according to the possible order, sampling will start as AABB, BBAA, ABBA, BAAB, ABAB, BABA. According to the order of the letters in the blocks, the mothers of the babies will be assigned to the intervention or control group. The next blocks will then be selected in the same way
Blinding (investigator's opinion)
Single blinded
Blinding description
The person analyzing the data will be blinded to the assignment of individuals in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Hamedan University of Medical Sciences
Street address
Begining of khajeh rashid Boulvard Hamedan University of Medical sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.UMSHA.REC.1399.1042
Health conditions studied
1
Description of health condition studied
Resilience and self-efficacy of breastfeeding mothers admitted to neonatal intensive care units
ICD-10 code
R09.0
ICD-10 code description
Asphyxia and hypoxemia
Primary outcomes
1
Description
Resilience
Timepoint
Before training, at the time of discharge and one week after discharge
Method of measurement
Conner- Davidson Resilience Scale
2
Description
breastfeeding self-efficacy
Timepoint
Before training, at the time of discharge and one week after discharge
Method of measurement
Dennis breastfeeding self-efficacy
Secondary outcomes
empty
Intervention groups
1
Description
To perform the intervention, the mothers of the experimental group, each mother individually attends two sessions of 30 minutes in the conference room and is taught how to perform cuddle care using the baby model. For this purpose, the researcher first teaches the mothers and helps them to embrace the baby's model and place it between her breast. while the mother's hand is around the baby's model and holds baby's model between her breasts with kindness and look at baby's model and caress baby's model head with the other hand. The mother practices the procedure under the supervision of a researcher to feel ready to perform kangaroo care for her baby. then researcher helps them wear a special blouse designed according to the kangaroo care standard and protocol. These blouses are loose, have sleeves, short buttons with a distance from the front of the dress that can be easily opened and closed. The mother then sits in a comfortable chair in a sitting or half-sitting position that feels comfortable. The researcher then places the baby, who has only a hat and diaper, vertically between the mother's two breasts. The bottom buttons of the mother's blouse will closed, this way the baby will be completely in the mother's breast and in the fabric fence, reducing the possibility of falls and hypothermia. The researcher then stands next to the mother and asks her to try to make eye contact with the model while smiling and caressing and talking to her. Mothers in the intervention group will perform kangaroo mother care for their babies three times a day and each time 30 minutes .
Category
Rehabilitation
2
Description
Control group: Mothers in the control group will receive a routine kangaroo mother care training (pamphlet)