Clinical trial NCT05578079: The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants
Official title: The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Premature
Pain
Music
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baby's heart rate
timeFrame: 2 minutes before collecting heel blood
measure: Baby's heart rate
timeFrame: During heel blood collection
measure: Baby's heart rate
timeFrame: 2 minutes after collecting heel blood
measure: Baby's respiratory rate
timeFrame: 2 minutes before collecting heel blood
measure: Baby's respiratory rate
timeFrame: During heel blood collection
measure: Baby's respiratory rate
timeFrame: 2 minutes after collecting heel blood
measure: Baby's oxygen saturation
timeFrame: 2 minutes before collecting heel blood
measure: Baby's oxygen saturation
timeFrame: During heel blood collection
measure: Baby's oxygen saturation
timeFrame: 2 minutes after collecting heel blood
measure: Premature Infant Pain Profile (PIPP)
timeFrame: 2 minutes before collecting heel blood
measure: Premature Infant Pain Profile (PIPP)
timeFrame: During heel blood collection
measure: Premature Infant Pain Profile (PIPP)
timeFrame: 2 minutes after collecting heel blood
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Research and Training Hospital
Study officials:
affiliation: Tepecik Research and Training Hospital
name: Defne ENGUR, Assoc.Prof.
role: STUDY_CHAIR
References: