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The effect of recorded maternal heart rate on sleep and Physiological Parameters in preterm infants.

The effect of recorded maternal heart rate on sleep and Physiological Parameters in preterm infants.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016080629210N1
Enrollment
75
Registered
2016-12-19
Start date
2016-05-17
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature infant. Disorders related to short gestation and low birth weight, not elsewhere classified

Interventions

Intervention 1: 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 inf
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 4
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.
Group III: intervention: The recorded sound of mother's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes.

Sponsors

Vice Chancellor For Research, Mashhad University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Months to 8 Months

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The duration of deep sleep. Timepoint: After intervention. Method of measurement: Ales doctor tools.;Respiratory rate. Timepoint: Q 5 minute from 10 minutes before intervention until 10 minutes after intervention. Method of measurement: Observation.;Heart rate. Timepoint: Q 1 minute from 10 minutes before intervention until 10 minutes after intervention. Method of measurement: Monitor.;Oxygen saturation. Timepoint: Q 1 minute from 10 minutes before intervention until 10 minutes after intervention. Method of measurement: Monitor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Yazdani

Mashhad University Of Medical Sciences

yazdaniz931@mums.ac.ir; yazdani.zahra.sh64@gmail.com+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026