The study was a randomized clinical trial on 60 term infants hospitalized in Baghiatollah Hospital in 2014. The newborns were randomly divided into intervention(n = 30) and control groups (n = 30). The infants of the intervention group received their mother's heartbeat 10 minutes before the bleeding was started up to 10 minutes after the bleeding was completed. Control group infants received blood samples without heartbeat. Pain intensity every 10 minutes in 3 steps: 10 minutes before the intervention (before playing the mother's heart sounds), during intervention, and 10 minutes after the intervention (immediately after the completion of the sound) with the Infant Pain Scale (NIPS) Neonatal Scale and Physiological variables were recorded by mobile pulsed oximetry device.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072916225N3
Registration date:2017-08-07, 1396/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
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 Hospital
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 mother's heart rate on physiological responses caused by painful stimuli in newborns hospitalized in NICU
Public title
The effect of mother's heart rate in hospitalized neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Infants hospitalized in neonatal intensive care units when measuring pain or at least 3 hours before it, Sedatives have not received; The lack of Underlying disease and extensive surgery ; The lack of crippling diseases and anatomical defects members ; No hearing impaired; Must have at least 36 weeks gestational age. 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
Age
To 1 day 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
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
Mother's heart beat relationship to physiological responses from painful stimuli in infants admitted to the intensive care unit
ICD-10 code
ICD-10 code description
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 heartbeat 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 Hospital
Full name of responsible person
Baghiatollah Hospital
Street address
Mollasadra street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiatollah Hospital
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
Baqiatollah hospital
Full name of responsible person
Elham Azarmnejad
Position
Master of nursing
Other areas of specialty/work
Street address
Mollasadra street
City
Tehran
Postal code
Phone
+98 217736000600
Fax
Email
azarm.elham@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiatollah Hospital
Full name of responsible person
Elham Azarmnejad
Position
Master of nursing
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 Hospital
Full name of responsible person
azarm.elham@yahoo.com
Position
Master of nursing
Other areas of specialty/work
Street address
Shahed alley- Kelagermahale street
City
Jouybar
Postal code
Phone
+98 11 4254 2397
Fax
Email
azarm.elham@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)