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Effect of Hearing Simulated Intrauterine Sound on the Behavioral and Physiological Indicators of pain due to Blood Sampling in Preterm Infants

Effect of Hearing Simulated Intrauterine Sound on the Behavioral and Physiological Indicators of pain due to Blood Sampling in Preterm Infants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190520043648N1
Enrollment
80
Registered
2019-07-04
Start date
2019-06-22
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

behavioral and physiological Indicators of pain. Encounter for routine child health examination

Interventions

Intervention 1: Intervention group:In the present study,Intrauterine simulated sound will be provided with medical educational software for intrauterine sound.This sound contains a relaxed Intrauterin

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 6 Days

Inclusion criteria

Inclusion criteria: Premature Infants Aged 28 to 36 Weeks Weight less than 2500 grams Chronological Age is Less than one Week Physiological Stability (heart rate less than 160 beats per minute, less than 60 breaths per minute. Arterial oxygen saturation greater than 85%) First Minute apgar and fifth minute apgar = 7 more than 30 minutes passed from the last feed Positive Moro Reflex

Exclusion criteria

Exclusion criteria: History of intubation Use of analgesic or relaxing drugs and anticonvulsant during the last 24 hours Having intraventricular hemorrhage or leukomalacia Having any genetic abnormalities and any neurological disorder Shaking and touching the neonate during blood sampling by the mothers Within 4 hours before the intervention, any painful intervention or analgesic medication or other pharmacological or Non-pharmacological intervention has been performed Mother addiction The presence of any acute or chronic disease before or during pregnancy of the mother (such as heart disease and diabetes, preeclampsia, history of depression, etc.) Receiving any narcotic drug during and after delivery(In lactating mothers)

Design outcomes

Primary

MeasureTime frame
Pain level in the Neonatal Infant Pain Scale (NIPS) Behavioral checklist. Timepoint: The researcher will filming neonatal behavioral changes with a video camera each time for 1 minute in 3 steps, including 5 minutes before and after intervention, during which time (during blood sampling time) and 5 minutes after the completion of blood sampling. Method of measurement: Neonatal Infant Pain Scale (NIPS) Behavioral checklist.

Secondary

MeasureTime frame
Mean score of physiological indices including heart rate and hemoglobin saturation from oxygen. Timepoint: Each time for 1 minute in 3 steps including 5 minutes before and after the intervention, during it (during the bleeding time) and 5 minutes after the completion of blood sampling. Method of measurement: For measuring physiological parameters of pain including heart rate and hemoglobin saturation of oxygen, a calibrate pulse oximetry device, the model NOVAMETRIX will be used.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShamime Yarahmadi

Rasht University of Medical Sciences

Yarahmadi.shamim@gmail.com+98 13 3377 3366

Outcome results

None listed

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