The purpose of this study was to Assess of impact the auditory familiar stimulation on physiological responses caused by painful stimuli in newborns hospitalized in NICU. Inclusion criteria: Infants hospitalized in neonatal intensive care units in selected hospitals in Tehran; when measuring pain or at least 3 hours before it, Sedatives have not received; The lack of Underlying disease and extensive surgery (e.g., abdominal surgery, etc.) that is causing pain; The lack of crippling diseases and anatomical defects members (hands and feet); No hearing impaired; At least 36 weeks gestational age; Requiring Blood samples is. Exclusion criteria: During the study, the infant is in trouble, as it is connected to the ventilator; when sampling is not done once the needles into the skin; when sedatives or tranquilizers should be used for infants during Blood samples. The population included all infants admitted to the intensive care unit of a hospital, sampling is simple random sampling. There are 60 samples and is performed by both sexes. From 10 minutes before to 10 minutes after taking blood samples mother's voice is played And physiological responses before, during and 10 minutes after blood samples are document and pain at the time of entry and one minute after needle insertion is measured Using NIPS scale, Then effects on physiological responses to pain compared with a control group of infants who are not playing mother's voice.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011416225N1
Registration date:2014-08-03, 1393/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-03, 1393/05/12
Registrant information
Name
Elham Azarmnejad
Name of organization / entity
Baghiatollah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982122286057-22289941
Email address
azarm.elham@yahoo.com
Recruitment status
Recruitment complete
Funding source
Baghiatollah University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-08-26, 1393/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing of impact the auditory familiar stimulation on physiological responses caused by painful stimuli in newborns hospitalized in NICU
Public title
Familiar auditory stimuli on physiological responses induced by painful stimulation in infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Infants hospitalized in neonatal intensive care units in selected hospitals in Tehran; when measuring pain or at least 3 hours before it, Sedatives have not received; The lack of Underlying disease and extensive surgery (e.g., abdominal surgery, etc.) that is causing pain; The lack of crippling diseases and anatomical defects members (hands and feet); No hearing impaired; Must have at least 36 weeks gestational age; Requiring Blood samples is.
Exclusion criteria: During the study, the infant is in trouble, as it is connected to the ventilator; when sampling is not done once the needles into the skin; when sedatives or tranquilizers should be used for infants during Blood samples
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baghiatollah University of Medical Sciences
Street address
Mollasadra street
City
Tehran
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
س/5291/3/340
Health conditions studied
1
Description of health condition studied
Understand the relationship between auditory stimulation on physiological responses induced by painful stimulation in infants hospitalized in intensive care
ICD-10 code
General sy
ICD-10 code description
Acute pain R52.0
Primary outcomes
1
Description
Physiological responses
Timepoint
Before the intervention, during intervention, post-intervention
Method of measurement
Using a pulse oximeter Mobile
Secondary outcomes
1
Description
Pain
Timepoint
Before the intervention, during intervention, post-intervention
Method of measurement
NIPS pain scale
Intervention groups
1
Description
In the test group, the mother's voice is played for 10 minutes before and 10 minutes after blood sampling continues. Mother's voice can be recorded using a software program, Cool Edit2000,and with two small speakers on either side of the Infant's head at a distance of 20 cm from the Infant's ear, placed in the incubator. The Voice being broadcast in about 50 to 60 dB is set.
Category
Other
2
Description
In the control group, no interventions are not just physiological variables (heart rate, respiratory rate, blood pressure, oxygen saturation, and pain) are measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiatollah Hospital
Full name of responsible person
Forough Sarhangy
Street address
Mollasadra street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baghiatollah University of Medical Sciences
Full name of responsible person
Dr. Rokhsari
Street address
Alley Borna-Sheikh Bahai Avenue South
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiatollah 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
Baghiatollah University of Medical Sciences
Full name of responsible person
Elham Azarmnejad
Position
Master student
Other areas of specialty/work
Street address
Shahed Alley-Kelagermahalle street
City
Jouybar
Postal code
4771966349
Phone
+98 11 4254 2397
Fax
Email
azarm.elham2yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiatollah University of Medical Sciences
Full name of responsible person
Elham Azarmnejad
Position
M.S
Other areas of specialty/work
Street address
Shahed alley- Kelagermahalle street
City
Jouybar
Postal code
4771966349
Phone
+98 11 4254 2397
Fax
Email
azarm.elham@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baghiatollah University of Medical Sciences
Full name of responsible person
Elham Azarmnejad
Position
MS
Other areas of specialty/work
Street address
Shahed alley- Kelagermahale street
City
Jouybar
Postal code
4771966349
Phone
+98 11 4254 2397
Fax
Email
azarm.elham2yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)