The effectiveness of embrace care combined with the music on attachment of mothers with premature infants in the NICU at the Al-Zahra hospital of Isfahan in 2015
This study will be done with aim to investigate the effectiveness of embrace care combined with the music on attachment of mothers with premature infants in the NICU at the Al-Zahra hospital of Isfahan in 2015. This is a non blind clinical trial.
The study population would be included all mothers of newborns with gestational age of 30 to 36 weeks that their babies is admission in the neonatal intensive care unit of Al-Zahra hospital in Isfahan, that 64 of them will selected and randomly will be placed in two experimental and control groups. In both groups, at baseline, mothers behavior during breast-feeding by using Avant mother-infant attachment questionnaire is recorded. In the intervention group with the beginning of mother embrace care,for 20 minutes instrumental music during three days (once a day) is played.in the control group just will perform the mother embrace care. Then in both groups by using mother-infant attachment check list, maternal behavior during breastfeeding for 15 minutes is recorded. This 15-minute, each minute is divided into 30 seconds. In first 30 seconds observation and in second 30 seconds behavior are recorded. If the mother contact with her baby is less than 15 minutes, assessment in that turn will not be accepted and will be evaluated in the next turn.
Inclusion criteria: Non-mother's addiction to drugs and alcohol and tobacco; No history or current risk of mental illness; The age of 18-40; Training and skills in the field of embrace care.
Exclusion criteria: Infant body temperature reduction; Increasing need for oxygen about 10 -20%.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010125601N5
Registration date:2016-02-09, 1394/11/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
Saeideh Aghagoli
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25366621496
Email address
aqagholi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Expected recruitment start date
2016-02-05, 1394/11/16
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of embrace care combined with the music on attachment of mothers with premature infants in the NICU at the Al-Zahra hospital of Isfahan in 2015
Public title
Effectiveness of embrace care combined with the music on attachment of mothers with premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non-mother's addiction to drugs and alcohol and tobacco; No history or current risk of mental illness; The age of 18-40; Training and skills in the field of embrace care.
Exclusion criteria: Infants with craniofacial deformities and other clear congenital malformations; Disturbing the stability and the clinical condition of the mother and newborn baby; Infant discharge before the end of the intervention; Infant body temperature reduction; Increasing need for oxygen of 10 -20%.
Age
From 7 months old to 9 months old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee Ethics, Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
Ir.mui.rec.1394.3.409
Health conditions studied
1
Description of health condition studied
premature babies care
ICD-10 code
Z76.3
ICD-10 code description
Healthy person accompanying sick person
Primary outcomes
1
Description
Mother - infant attachment
Timepoint
Baseline and end of study
Method of measurement
Avant mother-infant attachment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group with the beginning of mother embrace care, for 20 minutes instrumental music during three days (once a day)is played.
Category
Behavior
2
Description
In the control group just will perform the mother embrace car
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Maryam Vahdati
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Nematbakhsh
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Vahdati
Position
Student of Ms. Nursing of infant care
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
m.vahdati58@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Talakoub
Position
Ms.c of Nursing Child
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
talakoub@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Vahdati
Position
Student of Ms. Nursing of infant care
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
m.vahdati58@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)