.
we decided to study the effect of music on the anxiety of mothers of infants admitted to the neonatal intensive care unit.
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Design
This is a clinical trial study on 120 mothers admitted to the neonatal intensive care unit of hospitals of Amir Kola, Bouali Sina in Sari and Rohani in Babol.
Settings and conduct
This is a clinical trial study on 120 mothers who were admitted to the neonatal intensive care unit of hospitals of Amir Kola, Bouali Sina in Sari and Rohani in Babol. The samples are randomly divided into two groups of 60 experimental and control groups. For the experimental group, 10 minutes of soft music is broadcasted through mobile phones and headphones for each mother individually in 10 sessions. There is no intervention for the control group. Both groups of mothers fill the Spielberger anxiety questionnaire before the start of the study and on the 10th day.
Participants/Inclusion and exclusion criteria
the mothers of infants admitted to NICU, whom have a reading and writing literacy, their baby has any kind of chromosomal abnormalities,Their baby is hospitalized for at least 10 days in the NICU
Intervention groups
Mothers who receive music therapy are included in the intervention group.
Mothers who do not receive music therapy fall into the control group
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170820035793N2
Registration date:2018-05-06, 1397/02/16
Registration timing:retrospective
Last update:2018-05-06, 1397/02/16
Update count:0
Registration date
2018-05-06, 1397/02/16
Registrant information
Name
Azita Karimi
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
a.karimi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of music on anxiety in mothers of infants admitted to neonatal intensive care units
Public title
Effect of music on anxiety in mothers of infants admitted to neonatal intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The samples will be selected from the mothers of infants admitted to NICU.
Mothers will enter a research that does not have chronic, physical and psychological illnesses.
whom have a reading and writing literacy.
Their baby has any kind of chromosomal abnormalities, have no severe critical conditions such as intraventricular hemorrhage and cardiopulmonary arrest at birth.
It is their first maternal experience.
Their baby is hospitalized for at least 10 days in the NICU.
Exclusion criteria:
. The exit criteria consist of Mothers with history of chronic physical and psychological illness,
Have more than one child.
Mothers who are not interested in music .
whose baby has chromosomal disorders or critical conditions such as intravesical hemorrhage and cardiopulmonary arrest at birth.
Mother's lack of cooperation to continue during intervention.
Mother-to-be-known addiction to alcohol and addiction and psychotropic drugs.
Getting sleepy medications by the mother on the day of the intervention.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Then, they will be randomly assigned to two groups: experimental (60 people) and control (60 people). The questionnaires are already marketed divided into with or without music, and the mother who randomly takes the music questionnaire will be in the experimental group.
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
The Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafroz AV,Babol University of Medical Sciences, Babol, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2017-07-28, 1396/05/06
Ethics committee reference number
MUBABOL.HRI.REC1396.42
Health conditions studied
1
Description of health condition studied
Anxiety of Mother
ICD-10 code
F06.0
ICD-10 code description
Psychotic disorder with hallucinations due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
Ten days
Method of measurement
the Spielberger anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group": Whit Music
Category
Treatment - Devices
2
Description
"Control group": whitout music
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Hospital
Full name of responsible person
Azita Karimi
Street address
Boali Hospital، Pasdaran boulevadr، Sari، Mazandaran Province، IR Iran
City
Sari
Province
Mazandaran
Postal code
4761856464
Phone
+98 11 4227 9933
Email
a.karimi2646@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ghadimi Reza
Street address
Babol university Medical sciences Ganjafroz street
City
Babol
Province
Mazandaran
Postal code
981132194727
Phone
+98 11 4227 9933
Email
a.karimi2646@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Azita Karimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4761856464
Phone
+98 11 4227 9933
Email
a.karimi2646@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyedeh Roghayeh Gafarian Amiri
Position
Assiatant professor school ofMedical Faqulty member of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11321920023
Fax
+98 11 3219 9936
Email
jafarianamiri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azita Karimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol, University of MedicalSciences, Ganjafroz street,Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
4761856464
Phone
+98 11 4227 9933
Email
a.karimi2646@yahoo.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