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CompletedNCT05578079Updated Jul 24, 2023

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

An interventional study of Music and Music in Pain, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey. Open to participants aged 32 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
32 Weeks to 37 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain

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Keywords

  • Premature
  • Pain
  • Music
03

In context

Premature Birth

2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 1,691 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 192 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
32 Weeks to 37 Weeks
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Control group

    No music will be played to the control group.

  • Active comparator
    Intervention 1

    The Intervention-1 group will listen to the music which determined by the researchers by examining the literature (DOI: 10.4274/jpr.24892). The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach.

    Other: Music

  • Active comparator
    Intervention 2

    The Intervention-2 group will listen to lullaby.

    Other: Music

Interventions

  • OtherMusic

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

  • OtherMusic

    Intervention-2 group will listen to lullaby.

06

What researchers measure

Primary outcomes

  1. Baby's heart rate

    The baby's pulse rate will be measured.

    Time frame: 2 minutes before collecting heel blood

  2. Baby's heart rate

    The baby's pulse rate will be measured.

    Time frame: During heel blood collection

  3. Baby's heart rate

    The baby's pulse rate will be measured.

    Time frame: 2 minutes after collecting heel blood

  4. Baby's respiratory rate

    The baby's respiratory rate will be measured.

    Time frame: 2 minutes before collecting heel blood

  5. Baby's respiratory rate

    The baby's respiratory rate will be measured.

    Time frame: During heel blood collection

  6. Baby's respiratory rate

    The baby's respiratory rate will be measured.

    Time frame: 2 minutes after collecting heel blood

  7. Baby's oxygen saturation

    The baby's oxygen saturation will be measured.

    Time frame: 2 minutes before collecting heel blood

  8. Baby's oxygen saturation

    The baby's oxygen saturation will be measured.

    Time frame: During heel blood collection

  9. Baby's oxygen saturation

    The baby's oxygen saturation will be measured.

    Time frame: 2 minutes after collecting heel blood

  10. Premature Infant Pain Profile (PIPP)

    PIPP scores will be evaluated separately by two experts in the field.

    Time frame: 2 minutes before collecting heel blood

  11. Premature Infant Pain Profile (PIPP)

    PIPP scores will be evaluated separately by two experts in the field.

    Time frame: During heel blood collection

  12. Premature Infant Pain Profile (PIPP)

    PIPP scores will be evaluated separately by two experts in the field.

    Time frame: 2 minutes after collecting heel blood

07

Study locations

1 site
  • Tepecik Research and Training Hospital
    İzmir, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05578079
Lead sponsor
Izmir Katip Celebi University
Responsible party
Pınar Dogan (Research Ass., Izmir Katip Celebi University) — Principal investigator
First posted
Oct 13, 2022
Start date
Oct 14, 2022
Primary completion
Apr 25, 2023
Completion
Apr 25, 2023
Last update
Jul 24, 2023

Study contacts

Defne ENGUR, Assoc.Prof.
study chair · Tepecik Research and Training Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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