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The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants

The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05578079
Enrollment
60
Registered
2022-10-13
Start date
2022-10-14
Completion date
2023-04-25
Last updated
2023-07-24

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

Conditions

Pain

Keywords

Premature, Pain, Music

Brief summary

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby. Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

Detailed description

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby. Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

Interventions

OTHERMusic

Intervention-1 group will listen to the classical music that the Arts of Fugue by Bach.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 37 Weeks
Healthy volunteers
No

Inclusion criteria

* Parent being voluntary to participate in the study * Being born at 32-36+6 gestastional week * The baby's condition is stable * Having passed hearing test * Having not congenital malformation

Exclusion criteria

* Birth weight below 2500 g * Receiving analgesics or sedatives * Need for mechanical ventilation * Heel blood collection is not successful in the first time

Design outcomes

Primary

MeasureTime frameDescription
Baby's heart rate2 minutes before collecting heel bloodThe baby's pulse rate will be measured.
Baby's respiratory rate2 minutes before collecting heel bloodThe baby's respiratory rate will be measured.
Baby's oxygen saturation2 minutes before collecting heel bloodThe baby's oxygen saturation will be measured.
Premature Infant Pain Profile (PIPP)2 minutes before collecting heel bloodPIPP scores will be evaluated separately by two experts in the field.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026