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The Effect of Music Played During Heel Blood Collection on Pain in Premature Babies

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05578079
Collaborator
(none)
108
Enrollment
1
Location
3
Arms
11.6
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music
  • Other: Music
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Music Played During Heel Blood Collection on Pain in Premature Babies: A Randomized Controlled Study
Anticipated Study Start Date :
Oct 14, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.
Active Comparator: Intervention 2

The Intervention-2 group will listen to lullaby.

Other: Music
Intervention-2 group will listen to lullaby.

Outcome Measures

Primary Outcome Measures

  1. Baby's heart rate [2 minutes before collecting heel blood]

    The baby's pulse rate will be measured.

  2. Baby's heart rate [During heel blood collection]

    The baby's pulse rate will be measured.

  3. Baby's heart rate [2 minutes after collecting heel blood]

    The baby's pulse rate will be measured.

  4. Baby's respiratory rate [2 minutes before collecting heel blood]

    The baby's respiratory rate will be measured.

  5. Baby's respiratory rate [During heel blood collection]

    The baby's respiratory rate will be measured.

  6. Baby's respiratory rate [2 minutes after collecting heel blood]

    The baby's respiratory rate will be measured.

  7. Baby's oxygen saturation [2 minutes before collecting heel blood]

    The baby's oxygen saturation will be measured.

  8. Baby's oxygen saturation [During heel blood collection]

    The baby's oxygen saturation will be measured.

  9. Baby's oxygen saturation [2 minutes after collecting heel blood]

    The baby's oxygen saturation will be measured.

  10. Premature Infant Pain Profile (PIPP) [2 minutes before collecting heel blood]

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

  11. Premature Infant Pain Profile (PIPP) [During heel blood collection]

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

  12. Premature Infant Pain Profile (PIPP) [2 minutes after collecting heel blood]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
32 Weeks to 37 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Families being voluntary to participate in the study

  • Gestational age is 32-37 weeks

  • Not taking analgesics or sedatives

  • The baby's condition is stable

Exclusion Criteria:

  • Gestational age less than 32 weeks or greater than 37 weeks

  • Taking analgesics or sedatives

  • The baby's condition is unstable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tepecik Research and Training Hospital İzmir Turkey

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

  • Study Chair: Defne ENGUR, Assoc.Prof., Tepecik Research and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pınar Dogan, Research Ass., Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT05578079
Other Study ID Numbers:
  • 05
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pınar Dogan, Research Ass., Izmir Katip Celebi University
Premature
Pain
Music
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Oct 13, 2022