the effect of music and mother's lullaby on physiological responses and sleep of preterm infants
Design
Clinical trial with control group, with parallel groups, without blinding
Settings and conduct
The researcher will refer to Ali ebn Abitaleb hospital and then the sample according to inclusion criteria will be divided to three homogeneous groups. Intervention will perform for each group once a day for 14 days. Physiological responses will be documented 10 min before intervention, during intervention and 20 min after intervention and sleep status will record on first day of intervention and 14th day.
Participants/Inclusion and exclusion criteria
inclusion criteria: Infants with gestational age more than 30 weeks,
infants without congenital anomalies
Intervention groups
Intervention group1: they shall be held in their mother's tender embrace and recorded lullaby in Persian will play for 20 min for them.
Intervention group2: they shall be held in their mother's tender embrace and mother will sing for 20 min for them.
Control group: they shall be held in their mother's tender embrace without any intervention for 20 min.
Main outcome variables
Physiological responses,Sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216042011N1
Registration date:2019-02-15, 1397/11/26
Registration timing:prospective
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
monirsadat nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3252 6603
Email address
m.nematolahi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of music and mother`s lullaby on physiological responses and sleep of preterm infants in NICU
Public title
Comparing the effect of music and mother`s lullaby on physiological responses and sleep of preterm infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age more than 30 weeks
Lack of congenital anomalies
Lack of mechanical ventilation
Exclusion criteria:
having hear difficulties
receive sedatives three hours before intervention
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sample will be selected from preterm infants according to inclusion criteria,then by using of random numbers table, infants will be placed in three groups.
On Saturdays and Sundays, eligible babies will be placed in recording mother's lullaby group, on Mondays and Tuesdays will be placed in live mother's lullaby group , and on Wednesdays and Thursdays, the baby will not be subjected to any intervention.
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 Kerman University of Medical Sciences
Street address
,Medical University Campus,Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.KMU.REC.1397.269
Health conditions studied
1
Description of health condition studied
Physiological responses
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial oxygen saturation
Timepoint
Before, during and after intervention
Method of measurement
Pulseoximetery
2
Description
sleep
Timepoint
The first and the 14th day of intervention
Method of measurement
BISQ questionnare
3
Description
heart rate
Timepoint
Before, during and after intervention
Method of measurement
Cardiopulmonary Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:The First intervention group shall be held in their mother's tender embrace and by using the headphones, the recorded lullaby sounds in Persian will be set for twenty minutes every evening. Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days.
Category
Other
2
Description
Intervention group 2:The second intervention group shall be held in their mother's tender embrace and the mother will sing lullaby for twenty minutes. Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days.
Category
Other
3
Description
Control group: In this group, infant shall be held in their mother's tender embrace for 20 min without playing music for them.Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abitaleb
Full name of responsible person
monirsadat Nematollahi
Street address
Hazrat Ali ebn Abitaleb hospital, Mofateh Blvd.,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Fax
+98 34 3428 0022
Email
aliebn@rums.ac.ir
Web page address
www.http://aliebn.rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Dehnaviyeh
Street address
Kerman medical sciences university, Haft Bagh highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5402
Fax
+98 34 3132 5856
Email
rdehnavi@gmail.com
Web page address
http://kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Monirsadat Nematollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 1, Sheykh Ahmadkafi Aven. ,Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3252 6603
Fax
+98 34 3132 5856
Email
m.nematolahi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Monirsadat Nematollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Campus of Kerman university of medical sciences ,Haft bagh Alavi highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3252 6603
Fax
+98 34 3132 5856
Email
m.nematolahi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Monirsadat Nematollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No 1., Sheykh Ahmadkafi Aven., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3252 6603
Fax
+98 34 3132 5856
Email
m.nematolahi@kmu.ac.ir
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
relied on secrecy
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available