The current research is a clinical trial study, in which samples were selected using nonprobability purposive convenience sampling method, divided into 3 groups and enrolled into the study based on inclusion criteria. In this study, 75 infants with 48 hours old and gestational age between 28 to 34 weeks hospitalized in neonatal intensive care unit at Imam Reza and Omolbanin Hospitals in Mashhad, Iran, in addition to routine care, received recorded sound of mother's heartbeats twice a day for eight consecutive days. The infants in control group received routine care and silent headphones for 40 minutes. The infants in intervention group received recorded sound of mother's heartbeats for 20 minutes in addition to routine cares. The placebo group listened to the recorded sound of another person's heartbeats for 20 minutes. Each intervention for all three groups included a forty-minute period. The first ten minutes involved baseline measurements prior to playing the sound. In the second and third ten minutes, recorded sound of mother's heartbeats was played for the intervention and placebo groups. Finally, the sound was stopped and the related measurements were performed after playing the recorded sound in the fourth ten minutes. Data collected in each intervention included oxygen saturation percentage, heartbeat per minute, respiratory rate per five minutes and duration of deep sleep after playing the sound. An expert did infant hearing screening after discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080629210N1
Registration date:2016-12-19, 1395/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-19, 1395/09/29
Registrant information
Name
Zahra Yazdani
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
yazdaniz931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Sciences
Expected recruitment start date
2016-05-17, 1395/02/28
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of recorded maternal heart rate on sleep and Physiological Parameters in preterm infants.
Public title
The effect of recorded maternal heart rate on sleep and Physiological Parameters in preterm infants.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the infant must have spontaneous breathing and needs no mechanical ventilation; parents should be willing and consent to participate in the study; birth weight over 1000 g , no congenital abnormalities; lack of hearing problems in newborns; 28 to 34 weeks of gestational age; lack of clear infection; no maternal addiction.
Exclusion criteria: need for assisted mechanical ventilation during the intervention; unwillingness of parents to continue to participate in the project; Grade 3 and 4 intraventricular hemorrhage; history of alcohol and coffee consumption; successive apnea; incidence of seizures in newborns; hearing problems; intrauterine growth restriction (IUGR); anemia with hemoglobin≤ 10 g/dL(hemoglobin less or equal to 10 grams per deciliter)
Age
From 7 months old to 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Mashhad University Of Medical Science
Street address
Daneshgah Street
City
mashhad
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.MUMS.REC.1395.72
Health conditions studied
1
Description of health condition studied
Premature infant
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
The duration of deep sleep
Timepoint
After intervention
Method of measurement
Ales doctor tools
2
Description
Respiratory rate
Timepoint
Q 5 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Observation
3
Description
Heart rate
Timepoint
Q 1 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Monitor
4
Description
Oxygen saturation
Timepoint
Q 1 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Monitor
Secondary outcomes
empty
Intervention groups
1
Description
Group I: Control group: Infants receive no intervention in this group and they will be monitored in terms of dependent variables for 40 minutes. The headphone will be placed on the infants' ears for 40 minutes, but no sound will be played.
Category
Other
2
Description
Group II: Placebo: The recorded sound of another person's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes.
Category
Other
3
Description
Group III: intervention: The recorded sound of mother's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Imam Reza Hospital
Full name of responsible person
Zahra Yazdani
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Mashhad Omolbanin Hospital
Full name of responsible person
Zahra Yazdani
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Mashhad University Of Medical Sciences
Full name of responsible person
Tayebeh Reyhani
Street address
Faculty of Nursing and Midwifery
City
Mashhad
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, Mashhad University Of Medical Sciences