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Completed

NCT Number: NCT05578079

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

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.

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Key information

Conditions

Pain Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

32 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tepecik Research and Training Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

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

Primary outcomes

  1. Baby's heart rate

    Time frame: 2 minutes before collecting heel blood

    The baby's pulse rate will be measured.

  2. Baby's heart rate

    Time frame: During heel blood collection

    The baby's pulse rate will be measured.

  3. Baby's heart rate

    Time frame: 2 minutes after collecting heel blood

    The baby's pulse rate will be measured.

  4. Baby's respiratory rate

    Time frame: 2 minutes before collecting heel blood

    The baby's respiratory rate will be measured.

  5. Baby's respiratory rate

    Time frame: During heel blood collection

    The baby's respiratory rate will be measured.

  6. Baby's respiratory rate

    Time frame: 2 minutes after collecting heel blood

    The baby's respiratory rate will be measured.

  7. Baby's oxygen saturation

    Time frame: 2 minutes before collecting heel blood

    The baby's oxygen saturation will be measured.

  8. Baby's oxygen saturation

    Time frame: During heel blood collection

    The baby's oxygen saturation will be measured.

  9. Baby's oxygen saturation

    Time frame: 2 minutes after collecting heel blood

    The baby's oxygen saturation will be measured.

  10. Premature Infant Pain Profile (PIPP)

    Time frame: 2 minutes before collecting heel blood

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

  11. Premature Infant Pain Profile (PIPP)

    Time frame: During heel blood collection

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

  12. Premature Infant Pain Profile (PIPP)

    Time frame: 2 minutes after collecting heel blood

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

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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